Feasibility of the Hemomindful Program: a mindfulness-based program performed during hemodialysisAbstract
Introduction: Recent evidence indicates that mindfulness-based programs (MBPs) improve overall well-being and the ability to cope with kidney failure and hemodialysis stressors. However, intradialytic MBPs are poorly investigated.
Objective: The aim of this study was to describe the study protocol, evaluate the feasibility and perceived effects of the Hemomindful Program.
Methods: The results presented are from a mixed-methods randomized controlled trial. Thirty-two adults with kidney failure were randomized into the Hemomindful Program, which consisting of 8 weekly individual sessions of 1 hour delivered at chairside during hemodialysis combined with the treatment as usual (TAU), or TAU alone. Feasibility was assessed based on retention of the study protocol, adherence to the Hemomindful Program, its safety, and participant satisfaction. Semi-structured interviews were conducted with participants in the intervention arm immediately following treatment. Data were analyzed using descriptive statistics and discursive textual analysis.
Results: The overall rate of adherence to the study protocol was 84.38%. Among the participants in the Hemomindful Program (n = 16), 15 had four or more sessions (93.7%) and 12 completed the protocol (75%). Degree of importance attributed to the intervention was 8.58 (SD = 2.06) and intention to maintain the formal and informal mindfulness practices after the intervention was 6.67 (SD = 2.93) and 8.5 (SD = 2.31). The qualitative analysis indicated satisfaction with the perceived changes (greater awareness in daily activities, less reactivity, management of pain and discomfort) and the structure of the program.
Conclusion: The Hemomindful Program showed positive indicators of feasibility, with good retention, acceptability and safety.
Keywords:
Mindfulness; Hemodialysis; Kidney Failure, Chronic; Pain; Feasibility Studies
Resumo
Introdução: egundo evidências recentes, os programas baseados em mindfulness (PBM) melhoram o bem-estar geral e a capacidade de lidar com a insuficiência renal e os fatores de estresse na hemodiálise. Entretanto, PBM intradialíticos são pouco investigados.
Objetivo: Descrever o protocolo do estudo, avaliar a viabilidade e efeitos percebidos do Programa Hemomindful.
Métodos: Os resultados apresentados são de um ensaio clínico randomizado de métodos mistos. Trinta e dois adultos com insuficiência renal foram randomizados para o Programa Hemomindful, que consiste em 8 sessões individuais semanais de 1 hora realizadas na cadeira durante a hemodiálise, combinadas com o tratamento usual (TAU), ou TAU isolado. A viabilidade foi avaliada conforme retenção do protocolo, adesão ao Programa Hemomindful, sua segurança e satisfação do participante. Realizamos entrevistas semiestruturadas com participantes do braço de intervenção imediatamente após o tratamento. Dados foram analisados utilizando estatísticas descritivas e análise textual discursiva.
Resultados: A taxa geral de adesão ao protocolo foi de 84,38%. Entre os participantes do Programa (n = 16), 15 realizaram quatro ou mais sessões (93,7%) e 12 completaram o protocolo (75%). O grau de importância atribuído à intervenção foi 8,58 (DP = 2,06) e a intenção de manter as práticas formais e informais de mindfulness após a intervenção foi 6,67 (DP = 2,93) e 8,5 (DP = 2,31). A análise qualitativa indicou satisfação com as mudanças percebidas (maior consciência nas atividades diárias, menor reatividade, manejo da dor e desconforto) e com a estrutura do programa.
Conclusão: O Programa Hemomindful apresentou indicadores positivos de viabilidade, com boa retenção, aceitabilidade e segurança.
Introduction
People with kidney failure undergoing regular dialysis often have a significant number of symptoms that can disrupt daily activities and reduce overall life satisfaction1. Numerous symptoms are documented, including fatigue, pain, low mood, dry skin, disrupted sleep, and muscle cramps, with fatigue being the most prevalent and pain the most severe2,3. People in hemodialysis (HD) have a lower quality of life and are more likely to develop mental disorders such as depression and anxiety1,4, higher levels of stress5, and other comorbidities, which makes adherence to treatment and survival more difficult in this population.
Due to the complexity of kidney failure, complementary interventions to hemodialysis that help reduce stressors in this population are necessary. Recent evidence indicates that mindfulness-based programs (MBPs) to improve general well-being and increase the ability to deal with kidney failure and hemodialysis stressors6,7 may be a promising and safe complementary therapy during hemodialysis, acting on quality of life and physical aspects of the kidney failure disease8.
There are many studies that indicate the positive effects of MBPs in improving the well-being of people with chronic diseases9,10,11,12. Mindfulness is defined as the awareness of being in the present moment, paying attention to what is happening in our body, mind, and emotions, and to all internal or external events, without judgment or resistance, with an open and gentle atitude13. MBPs are based on the knowledge of contemplative traditions, medicine, psychology, and education. They approach the experience with a focus on the present moment, using skills and qualities of mindfulness meditation practice to involve participants in intensive training based on experiential investigation14.
Some studies have assessed the feasibility and effects of traditional MBPs, such as Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR), with positive results in participant quality of life and self-efficacy15. They are considered feasible strategies as a complementary treatment for Renal Replacement Therapy (RRT)8,16. However, other studies report that conventional MBPs such as MBSR and MBCT, with weekly sessions of two hours or more and long mindfulness practices (45 minutes), can decrease the adherence of people with kidney failure, especially those in HD, due to the stressful treatment at the physical, emotional, and psychological level17, the time demands, and travel costs8,18.
The feasibility and effects of MBPs adapted to the specific needs of people with a high demand of health services, such as older adults19 and people on RRT6,8,17,20,21,22,23,24, have improved. Reilly-Spong et al.17 adapted the MBSR model to a hybrid format of teleconference and face-to-face meetings for people in RRT and demonstrated that this model allowed for a shorter travel time and reduced travel costs. Participants suggested performing the intervention during HD to help manage the pain and anxiety that usually arise during sessions. However, few studies evaluated the feasibility of mindfulness-based interventions (MBIs) performed during HD sessions in adults8. These studies propose interventions with brief mindfulness meditation practices (5–30 minutes) with the support of audios20,22,23,24 or with guided practices using virtual reality glasses (25 minutes) with auditory and visual resources21 during HD. However, in these models, the shared practice and interaction between instructor and participant is minimal or nonexistent. These methodological elements are recommended in the Guidelines of Good Practice and Integrity regarding MBPs, and contextual treatment approaches are based on mindfulness and acceptance14,25. With the aim of expanding accessibility, reducing travel time and costs, and optimizing treatment time, the Hemomindful Program was developed, a new mindfulness-based stress management program during HD sessions6.
Robust research protocols and randomized controlled trials (RCT) to assess the feasibility and effects of MBIs in people with kidney failure are incipient and scarce7. Although recent studies in this population indicate that MBI are viable and safe, aspects of the protocol design, adherence to practices, and participant satisfaction using mixed method analysis need to be further explored. The present study aims to describe the study protocol of a randomized clinical trial and evaluate the feasibility and preliminary effects of the Hemomindful Program performed during hemodialysis.
Method
Study Design
The presented results are from a mixed-methods randomized controlled trial to evaluate the effects the Hemomindful Program combined with the usual treatment (TAU) (the intervention group - IG) compared to TAU alone (the control group - CG) concerning pain and heath conditions in people with kidney failure undergoing HD, with a follow-up of up to three months.
This study is registered in the Clinical Trials (NCT 04610593) website and was approved by the Research Ethics Committee of the Clinical Hospital of Porto Alegre (HCPA) (CAAE: 40658214.6.0000.5336 GPPG / HCPA).
Participants
A convenience sample was selected. Participants were eligible for the trial if they were aged 18 years or over, had been receiving HD treatment for at least three months, could speak and understand Portuguese, were literate, had an interest in participating in the research, and scored the minimum cut-off point (≥ 24) of the mini-mental state examination (MMSE)26. Participants were excluded if they had any severe mental health disorder (diagnosed by the medical team), were medically unstable, or had previous experience with meditation or any other mind-body interventions (e.g. yoga) in the past 12 months.
Interventions
Usual treatment in the hemodialysis unit
The usual care for people with kidney failure who perform HD was offered to all participants by professionals from different areas (medicine, nursing, nutrition, physical education, pharmacy) who assist them according to the individual treatment plan.
Hemomindful program
The program is a standardized MBP for stress management and quality of live promotion for people with kidney failure undergoing HD. The intervention was explained in a handbook and consisted of eight weekly sessions of up to 60 minutes performed individually at the bedside. It was designed considering the characteristics and needs of this population, and based on the MBSR protocol27, mindfulness-based relapse prevention (MBRP)12, and Body in Mind Training (BMT)28. The Hemomindful Program includes mainly mindfulness meditation practices, in addition to cognitive and behavioral psychology strategies and health education to deal with stress, pain and challenges related to kidney failure and HD treatment.
The program is divided into three comprehensive themes and practices aiming to develop mindfulness skills gradually and progressively, encouraging greater kindness and acceptance of experiences throughout the program. Table 1 shows the details of themes, objectives, didactic content, and practices for each session.
Four main techniques of formal mindfulness meditation were worked on: mindful breathing, body scanning, conscious movements, and compassionate practice, as well as brief practices to be used informally in everyday life, whether to get off autopilot or deal with challenging situations, like pain. The brief practices include: Self-care pause, STOP (stop, take a breath, observe, proceed) and Self-compassionate pause.
Each session has different moments: Checking (how the participant is doing at that moment); mindfulness practice; inquiry of the experience; psychoeducation; home chores; and closure check. The mindfulness concept and skill are developed from the experience with exercises and 5 to 20-minute audio practices by the instructor, in which the participant and instructor practice together with the support of shared headphones and different guided practices. In each session, informative materials on the topic of the session, exercises and a diary were distributed to participants to describe their experiences with the practices during the week.
In addition, participants were encouraged to perform formal and informal practices at home and on other days at least once a day. To deepen their practice, they received audios of guided practices recorded by the instructor on CD or digital format. At the end of the intervention, the information materials used in each session were compiled in a manual to support continued practice.
The Hemomindful Program was conducted by a certified mindfulness instructor trained in the MBRP and BMT protocols, and consolidated meditative practice, and with more than ten years of experience. The instructor was part of the multi-professional team at the HD unit where the study was conducted.
Notes were made in field diaries and audio recording of all sessions were taken during the intervention to document participant receipt of treatment and any deviations from the intervention checklists.
Procedures
The screening involved checking the list of individuals seen at HD Unit and identifying those who met the eligibility criteria using information from electronic medical records. The project coordinator then explained the research in detail to each potential participant, informing about the voluntary nature of participation, and that they could leave the study at any time with no effect on their treatment. Those who agreed to participate in the study signed the informed consent form. A final screening and other data collection phases were conducted face to face by trained interviewers. After collecting baseline data, the intervention group (IG) participants received information about the Hemomindful Program, while the control group (CG) participants remained in the TAU routine, without receiving additional instruction, and were reminded that after completing the study they could undertake the program if they wished. Participants were not blinded to group status. The sample size was estimated based on previous research and on differences between groups at a significance level of 5% with a power of 85% and an effect size of Cohen d = 1.0. This required the enrollment of 30–40 participants (15–20 participants per group). Randomization was performed using the stratified 1:1 random allocation method. During the recruitment period (April –June 2019), 32 participants were enrolled, with 16 individuals randomized to the Hemomindful program (IG) and 16 individuals to the TAU (CG) (Figure 1). The randomization sequence was created with the R language statistical environment using the minDiff package29 by a researcher who was neither involved in the evaluations nor in the selection of participants.
Results related to the effects of the program included self-reported quantitative and qualitative measures and levels of inflammatory biomarkers measured at baseline, 8 weeks, and 3 months after the intervention (January – May 2020). Pain, assessed by the Profile of Chronic Pain: Screen - PCP:S scale30, was the primary outcome of the study. This study will focus on the study design, feasibility outcomes, and effects perceived by participants of the Hemomindful program, while the complete effectiveness outcomes of the program comparing CG and IG will be reported elsewhere.
Outcome Measures
The profile of the participants was assessed through a questionnaire with sociodemographic and clinical information, which was developed by the research team to obtain information, such as age, race, education, economic level of the participants according to the Brazilian Economic Research Association (ABEP)31 criteria, comorbidities, treatment time, and previous meditation.
The MMSE was used to track cognitive impairments26. The MMSE is composed of questions that correlate in five dimensions: concentration, language/praxis, orientation, memory, and attention, with a maximum score of 30 points. The 23/24 cut-off point is the most commonly used. This instrument was applied and validated for the Brazilian context, demonstrating high sensitivity and specificity in detecting cognitive impairment26.
Feasibility was assessed by the number of participants who completed the protocol, adherence to the Hemomindful Program, implementation, safety, and satisfaction with the treatment. Retention to the study protocol was assessed using the primary data of all participants at the beginning of the study.
Adherence to the Hemomindful Program was measured using the weekly records of the research team in the field diaries about participation in each session and frequency of formal and informal mindfulness practice at home reported by the participants (number of days per week). Implementation and safety were assessed based on field diary records of adverse events observed by the research team.
Satisfaction with the treatment and experience of the participants were assessed immediately after completion of the intervention (8 weeks post-randomization) through a semi-structured qualitative individual interview using a questionnaire for reflections on the Hemomindful program, adapted from Bowen and collaborators12, with closed-ended questions (answers on a Likert scale from 0 to 10; “10 = very likely/very important”) and open-ended questions addressing topics such as the degree of importance of the program, perceived changes, the intervention during HD sessions, the continuity of mindfulness practices after the intervention, and suggestions for improving the intervention for future use. The interviews were digitally recorded, anonymized, and transcribed verbatim for analysis. The interview took between 15 and 30 minutes.
Data Analysis
For quantitative data, descriptive statistical analysis was performed. Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed using frequency and proportion. Comparisons were evaluated by Pearson’s χ2 test or Student’s t-test. All numerical analyses were conducted in SPSS version 23. The qualitative data about treatment satisfaction and experience of the participants in the Hemomindful Program was literally transcription and the discursive textual analysis method was used, consisting of three stages: unitarization, categorization, and analysis of the categories32. The analysis was performed by two independent coders. Coding was based on a semantic approach in which the codes are derived from the explicit meaning of the data. They then independently coded the data on the main themes and theme categories. The categorization of the data was completed through an interactive process and a consensus approach to disagreements.
Quantitative descriptive analysis of the characteristics of the sample were carried out for the CG and IG groups, while the qualitative analysis was only carried out for the IG group.
Results
Baseline Characteristics
Of the 67 potential volunteers, 32 were selected (28 being ineligible and 7 declined to take part) (Figure 1). The average age was 55 years (min 24, max 84, SD = 15.6), the majority were women (n = 19; 59.4%), blacks and browns (according to self-reported skin color) represented 50% of the sample (n = 16), and most lived with family members (n = 29; 90.6%). Nineteen had primary or higher education (59.4%), 15.6% (n = 5) were in paid employment, and the majority of participants were in economic class C (n = 15; 46.8%). The duration of HD therapy, on average, was 6.28 years (min 0.3, max 20.3, SD = 5.67), and participants had an average of 3.94 comorbidities (SD = 2.32) associated with kidney failure, with pain being the most prevalent (n = 19; 59.37%). The groups were similar in terms of sociodemographic and clinical characteristics (Table 2).
Baseline characteristics of participants randomized to the Hemomindful Program or Usual As Treatment (TAU) (n = 32)
Retention in the Protocol and Baseline Data
None of the participants (n = 32) left the protocol (100% retention). Baseline data was collected from all participants at the start of the study. In the IG group, there were four drop-outs over the 8 weeks (25%) due to “tiredness” and “lack of motivation to practice” (n = 1), transfer to another treatment unit (n = 1), transplant (n = 1), and death (n = 1). In the CG group, one volunteer (6.25%) was lost due to kidney transplantation. The general rate of retention to the study protocol was 84.38%.
Adherence, Implementation, and safety of the Hemomindful Program
The participants of the IG group (n = 16), 93.75% (n = 15) performed four or more sessions of the Hemomindful Program and 75% (n = 12) completed the eight scheduled sessions. Some sessions had to be rescheduled because the participant was unwell at the scheduled time (e.g. nausea, vomiting, complications in the HD access), and were held on another day of HD planned for the participant.
During the study, all the participants provided data on mindfulness practice at home, 12 provided complete data for weeks 1-8 (intervention period) and four participants provided partial data that were used to estimate their average days of practice at home per week. Participants who completed the eight sessions of the Hemomindful Program (n = 12) reported an practicing formal mindfulness for an average of 1.88 (SD = 1.97) days and a total of 13.17 minutes (min 1, max 49; SD = 13.75) and a short or informal weekly practice of 3.79 (SD = 2.15). The program lasted 26.50 days (min 7, max 49; SD = 15.07) (days between the first and eighth sessions). The average weekly involvement with mindfulness practices at home was different according to the week evaluated, with more frequent formal practices at weeks 3 and 6 and informal practices at weeks 1 and 3 (Table 3).
Mean frequency (in days per week) of formal and informal mindfulness practice at home and throughout the period
The participants received 13 audios of mindfulness practices, ranging from 3’27” to 16’50”, totaling 147 minutes of guided practice. The main formal practices worked on were self-care pauses (n = 12), breathing (n = 10), and mountain meditation (n = 10). The informal practice of pausing or STOP (Stop, Take a breath, Observe, Proceed) to breathe was the most prevalent, mentioned by all participants (n = 16), and the practice of mindfulness when eating and conscious movements were mentioned 25 and 8 times, respectively, during the program. Participants also reported carrying out informal mindfulness when playing with their children and grandchildren, bathing, brushing their teeth, and gardening. They also reported changing their habits, such as watching less television, decreasing the use of cell phones, observing nature, painting, and taking more care of their appearance, among others.
During the study, no participant reported serious or unexpected adverse events. Some participants noticed mild and/or moderate side effects during the intervention, such as increased pain perception in conscious movement practices or when invited to investigate the experience of pain (n = 3) and anxiety (n = 3) during practice.
Satisfaction and Experience with the Treatment
Participants who completed the Hemomindful Program (n = 12, 75%) rated it as “very important”, with an average score of 8.58 (SD = 2.06). When asked why they attributed the chosen value, they mentioned that the program was important for different reasons, such as: “reducing stress”, “learning new things”, “spiritual benefit”, “tranquility”, “willpower”, “more mood”, “energy”, “disposition”, “learn”, “change for the better”, “know yourself better”, “enjoy the good things”. Among the participants who attributed lower values to the importance of the program (n = 2), one was unable to answer why, and another said that the program did not match his expectations.
Regarding the degree of interest in mindfulness at the end of the intervention, the participants had an average score of 8.5 (SD = 2.15) on a Likert scale from 0 to 10. On the probability of continuing to perform formal mindfulness practices (e.g., mindfulness of breathing, body scanning, conscious movements, among others) and informal ones (STOP, eating and walking with mindfulness, among others) they indicated an average score of 6.67 (SD = 2.93) and 8.5 (SD = 2.31), respectively.
From the answers to qualitative open-ended questions about their experience of the Hemomindful Program, two broad themes emerged: the participants’ perception of perceived changes and comments on the structure of the program, subdivided into three categories each, with representative quotes shown in Table 4.
When analyzing perceived changes, three categories emerged: mindfulness in daily activities, non-reactivity, and management of pain and discomfort. Participants reported that the program contributed to increased mindfulness in daily activities, helping them to be more present and aware when carrying out daily activities such as bathing, eating, walking, and dressing. In addition, they noticed changes in interpersonal relationships and in the way they related to the demands of everyday life, adopting a posture of greater observation and tranquility. As for non-reactivity, many participants perceived a change when relating to internal and external experiences, especially in relation to unpleasant experiences. The reports expressed how they learned to “step back and take a deep breath” to make conscious choices instead of simply reacting automatically to the experience. Some participants commented on the use of mindfulness practices to deal with the challenges of kidney failure and RRT, such as HD time, water restriction, and dietary changes imposed by treatment. Regarding the management of pain and discomfort, participants observed changes in dealing with these stressors. They reported that practicing mindfulness helped them to deal with physical sensations and unpleasant thoughts and emotions, and to make choices that helped their self-care and the regulation of their emotions. Attitudes such as recognizing and exploring the pain without trying to control it, as well as thoughts and emotions of “letting go” and using resources such as STOP to breathe and perform conscious movements were mentioned. Pain reduction and positive changes on an emotional level were reported. One participant reported that her pain increased when she observed the sensations of her body, and another said that she did not notice any pain-related changes.
On the program structure theme, the following categories emerged: better use of HD time; materials, practices, and staff; and continuing the program. The better use of HD time was mentioned by 50% (n = 6) of the participants who completed the intervention. They considered that, in addition to feeling the time passing faster, they could use the time to learn to practice mindfulness and deal with the anxiety and irritation that arise during HD. In respect of materials, the participants appreciated the use of some items during the intervention, such as the bell, headphones, and the practitioner’s manual. Most of the participants were satisfied (or “very satisfied”) with the mindfulness practices, with one participant suggesting that formal practices could be more objective and diverse. The majority were also satisfied with the content and the length of the sessions of the Hemomindful Program, with only one participant suggesting that the sessions could take less than an hour. Most participants reported that the presence and attitude of the research team and investigation of experiences by the instructor enabled good interaction and exchange of experiences. The majority of the participants reported that they would (or were likely to) continue the program because they considered it to be useful and it provided important learning opportunities.
Discussion
Our study shows that the Hemomindful Program presented positive indicators of feasibility. The retention rate in the Hemomindful Program was high compared to results from previous studies with people with kidney failure17,20,21,23,24, with 93.75% of the participants having four or more sessions and 75% completing the eight sessions of the program. Thomas et al.24 had a 71% retention rate in an MBI with brief mindfulness practices during HD compared to TAU only. In the feasibility study of an adapted MBSR17, carried out outside the context of HD treatment, with two face-to-face and six sessions by teleconference, 84% of participants had three or more sessions and only 36% completed the program. Other studies that investigated the feasibility and effects of MBI in reducing stress in people with kidney failure, carried out outside the of context using traditional group protocols, such as MBCT15 and MBSR33, did not clearly report the participants’ adherence rates. Dropouts in our study were due to similar reasons as in previous studies: tiredness, lack of interest in carrying out the program, transfer to another unit, transplantation, health deterioration, and death15,17,24.
Participants reported practicing formal mindfulness at home one or two days a week on average. Only one study on MBI for people with end-stage renal disease investigated their involvement with formal mindfulness practices at home, and the participants reported practicing three times a week on average24. Ribeiro et al.19 assessed adherence of older people (50-80 years) with multiple comorbidities to mindfulness practice during and after a 6-week intervention performed individually and found no association between duration of engagement and changes in psychological state and quality of live. An RCT that evaluated the effects of MBCT in preventing depression relapse showed an inverse association between the duration of formal mindfulness practice performed at home and the probability of relapse to depression34.
Informal mindfulness practices 4 or 5 days a week were reported by all participants. Other studies also showed greater adherence to informal mindfulness practices33,34,35. Research conducted with people practicing mindfulness for a year or more has shown that the frequency of informal practice is more important for increasing psychological well-being and flexibility than formal practice34.
Satisfaction with the Hemomindful Program was evidenced through quantitative and qualitative results, with the participants attributing a degree of importance (8.5) similar to that in another study performed during HD sessions (8.3)24 and better than that of a study with MBCT adapted for teleconferencing (8.0)17. Our results indicate that participating in the Hemomindful Program contributed to the extension of the participants’ mindfulness practices beyond the context of HD, especially when performing activities of daily living such as eating, dressing, walking, talking with friends and family, among others. Our results point to a reduced reactivity to everyday situations related both to factors associated with the kidney failure treatment, such as food and water restrictions, or use of medications, and to various personal and family situations. The habitual way of the human being is the “way of doing”, of solving problems with the aim of reducing the distance between where we are and where we would like to be. This mode is effective for solving external problems, but when it comes to solving internal problems, it only creates more problems, because when trying to search for causes and reasons why things are not as we would like them to be, thoughts of analysis, judgment and comparison often arise that can generate guilt, anxiety and stress12,13. The ability of mindfulness to consciously perceive internal and external experiences in an attentive, gentle, curious and non-judgmental way is the opposite of the automatic, reactive mode12,36.
A better management of pain and discomfort was one of the changes perceived by the participants. Mindfulness is an important construct in the field of chronic pain in adults, as it emphasizes a non-judgmental attitude towards the experience of the present moment, carefully observing - rather than reacting automatically – to the physical sensations, emotions and thoughts that are present27,37. MBPs are considered a promising complementary treatment for people suffering from pain such as headache38, back pain35 and fibromyalgia39. Studies suggest that practicing mindfulness regularly can lead to changes in pain acceptance and intensity perception39,40.
Few studies have evaluated the feasibility of MBI in the context of HD, which also proved to be feasible21,24. Studies are investigating the feasibility of an adapted intervention of the Hemomindful Program that follows the international recommendations on MBPs for clinical and educational research, with mindfulness practice as a central element, with solid conceptual bases and adequate psychoeducational support14,25. The qualitative analysis highlighted different parts of the program, such as the role of the instructor and research team, the way of teaching, the way instructors asked questions participants about their experiences, and gave them the opportunity to talk to other people. The importance of the experience of the investigation process for the development of mindfulness skills is described in other studies as an essential element in learning and the process of change12,14.
The use of different educational materials during the intervention were also valued by the participants. These resources are used to increase the focus during practice and facilitate learning6,34, and the decision to use them was based on difficulties reported in other studies in the context of HD24 and recommendations from studies with people with kidney failure outside the context of HD17,18.
Another important aspect is that the Hemomindful Program was conducted by an instructor who was part of the dialysis staff, which may have contributed to intervention adherence, given that MBPs developed by trained and certified care team professionals usually have better adherence results40.
Limitations and Future Directions
Our study has some limitations, which should be noted. First, the study used a convenience sample of patients from a single HD unit, which may have caused some bias in the results. Second, the Hemomindful Program is a multifaceted program composed of different mindfulness practices and psychoeducational contents and techniques, making it difficult to discern the relative importance of each element of the program. Future studies should, therefore, carry out RCTs with active control groups to identify the influence of each element of the program. Finally, adherence to formal and informal mindfulness practices was measured based on participant reports, which could result in an under- or over-notification of the practice performed. We consider it is important to improve ways of measuring adherence to formal and informal mindfulness practices and to evaluate the profile of people who adhere to certain practices. More research is needed to qualify the current intervention protocol and identify the mechanisms underlying the observed positive preliminary effects.
Conclusions
The Hemomindful Program was found to be a complementary intervention to TAU based on the positive indicators of feasibility and good retention, acceptability and safety. In addition, preliminary qualitative results were presented on the impact on the management of pain and discomfort associated with the treatment of HD and adherence to behaviors related to treatment, health and well-being of the Hemomindful Program participants. According to our results, these benefits not only help with pain management, but also contribute to improving general well-being during HD treatment. If further studies support these effects, the Hemomindful Program can be useful in a broad spectrum of health conditions to help reduce pain-related suffering.
Acknowledgments
We are sincerely grateful to everyone who participated in this study. We would also like to thank the Hemodialysis Unit team of the Hospital de Clínicas de Porto Alegre, especially the nursing team who highly contributed to the study. Special thanks to the nurse Maria Conceição Proença for her unwavering support to this research and the pursuit of holistic and multiprofessional work. To the support of the Research and Graduate Groups of the HCPA and Fundo de Incentivo à Pesquisa (FIPE); to the PUCRS and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); and to everyone who somehow made this study possible. This study is endorsed by the Grupo Brasileiro de Reabilitação em Nefrologia (GBREN). The interpretation and conclusions contained herein are those of the researchers and do not represent the views of GBREN.
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Note – TAU: Treatment as Usual.
