Effect of Bedtime Mindfulness Meditation on Anxiety and Spiritual Well-Being in Hemodialysis Patients (BM-BOM)

Effect of Bedtime Meditation on Spiritual Well-Being and Anxiety in Hemodialysis Patients

This study evaluates whether Bedtime Meditation Based on Mindfulness (BM-BOM) can reduce anxiety and improve spiritual well-being in patients undergoing hemodialysis.

People receiving long-term hemodialysis often experience emotional stress, anxiety, and spiritual distress due to chronic illness, treatment burden, and lifestyle limitations. These problems may affect their quality of life and overall well-being. Mindfulness meditation is a simple, low-cost, and safe non-drug approach that may help patients feel calmer, more focused, and more spiritually connected.

In this study, adult hemodialysis patients are randomly assigned to one of two groups. The intervention group receives a guided mindfulness meditation program. Participants attend a single 2.5-hour training session led by a certified mindfulness instructor and then practice guided meditation during their hemodialysis sessions twice a week for four weeks using audio recordings. Each session lasts approximately 15 minutes and includes breathing awareness, body awareness, and short reflection.

The control group follows the same schedule and duration but rests quietly with eyes closed without guided meditation.

Participants complete questionnaires before and after the four-week program to measure anxiety and spiritual well-being. The results of this study will help determine whether guided mindfulness meditation can be used as a practical and supportive complementary therapy for patients receiving hemodialysis.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Anxiety; Chronic Kidney Disease; Spiritual Well-being
• Intervention / Treatment: Behavioral: Bedtime Meditation Based on Mindfulness (BM-BOM); Behavioral: Passive Rest (Control)

Detailed Description

This randomized controlled trial investigates the effectiveness of Bedtime Meditation Based on Mindfulness (BM-BOM) in reducing anxiety and improving spiritual well-being among patients undergoing maintenance hemodialysis.

Hemodialysis patients frequently experience psychological distress, including anxiety, emotional burden, and spiritual challenges associated with long-term treatment dependency, physical limitations, and uncertainty about health outcomes. Although standard hemodialysis care focuses primarily on physiological management, psychosocial and spiritual needs are often insufficiently addressed. Mindfulness-based interventions offer a structured, non-pharmacological approach that promotes present-moment awareness, emotional regulation, relaxation, and adaptive coping. However, evidence regarding their combined effects on anxiety and spiritual well-being in hemodialysis populations remains limited.

This study employs a single-blind randomized controlled design with pre- and post-intervention measurements. Eligible participants are adult patients with stage V chronic kidney disease who have been receiving outpatient hemodialysis for at least three months and are able to communicate effectively and provide informed consent. Participants with severe cognitive impairment, diagnosed psychological disorders, or medical conditions that prevent participation in the intervention are excluded.

A total of 58 participants are randomly allocated in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence. Participants are blinded to group allocation. Outcomes are assessed using self-reported standardized questionnaires administered at baseline and again after completion of the four-week intervention period.

Participants in the intervention group receive a structured mindfulness program. The program begins with a single 2.5-hour face-to-face training session delivered by a certified mindfulness practitioner, introducing core principles of mindfulness, breathing awareness, and body awareness. Following the training, participants practice guided BM-BOM at the beginning of each hemodialysis session, twice weekly for four consecutive weeks. Each session lasts approximately 15 minutes and is delivered using standardized audio guidance in the Indonesian language. The audio guidance includes three sequential components: focused breathing awareness (approximately 5 minutes), body scan and bodily awareness (approximately 7 minutes), and closing reflection and grounding (approximately 3 minutes). Attendance and adherence are monitored during each session.

Participants in the control group follow the same schedule, setting, and duration but do not receive mindfulness guidance. They are instructed to rest quietly with eyes closed during the first 15 minutes of hemodialysis. This approach controls for time, attention, and environmental exposure while minimizing expectancy effects.

The primary outcomes are changes in spiritual well-being and anxiety levels from baseline to post-intervention. Spiritual well-being is measured using the Indonesian version of the Spiritual Well-Being Scale (SWBS), and anxiety is assessed using the Indonesian version of the Zung Self-Rating Anxiety Scale (ZSARS). Both instruments have demonstrated acceptable validity and reliability in Indonesian populations.

Data analysis includes descriptive statistics to summarize participant characteristics and inferential testing to compare within-group and between-group changes. Normality and homogeneity assumptions are evaluated prior to hypothesis testing. Paired statistical tests are used to assess pre- and post-intervention changes within groups, and independent statistical tests are used to compare outcome differences between groups. Effect sizes are calculated to support interpretation of clinical relevance.

Ethical approval is obtained from the institutional research ethics committee, and all participants provide written informed consent prior to participation. Participant confidentiality is maintained throughout the study in accordance with ethical guidelines.

The findings of this trial aim to provide evidence on the feasibility, safety, and effectiveness of guided mindfulness meditation as a complementary intervention that can be integrated into routine hemodialysis care to support psychological and spiritual well-being.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Centre Java
    • Surakarta, Centre Java, Indonesia, 57126
      • UNS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with chronic kidney disease (CKD) stage V.
• Undergoing outpatient hemodialysis for at least three months.
• Aged 18 years or older.
• Able to communicate effectively.
• Willing to participate and provide written informed consent.

Exclusion Criteria:

• Severe cognitive impairment.
• Diagnosed psychological or psychiatric disorders.
• Any medical condition that prevents participation in the mindfulness intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BM-BOM Intervention Group; Participants received a 2.5-hour face-to-face mindfulness training delivered by a certified practitioner, followed by guided Bedtime Meditation Based on Mindfulness (BM-BOM) practice during hemodialysis sessions twice weekly for four consecutive weeks. Each session lasted approximately 15 minutes and was delivered using standardized audio guidance consisting of breathing awareness, body scan, and closing reflection.	Behavioral: Bedtime Meditation Based on Mindfulness (BM-BOM); A structured mindfulness-based intervention consisting of guided breathing awareness, body scan, and closing reflection delivered via standardized audio recordings. Participants practiced BM-BOM for approximately 15 minutes during hemodialysis sessions twice per week for four weeks after completing a 2.5-hour introductory training session led by a certified mindfulness practitioner.
Active Comparator: Control Group (Passive Rest); Participants rested quietly with their eyes closed for approximately 15 minutes at the beginning of each hemodialysis session twice weekly for four weeks, without structured mindfulness guidance. This controlled for time, attention, and treatment environment	Behavioral: Passive Rest (Control); Participants rested quietly with eyes closed for approximately 15 minutes during hemodialysis sessions without any guided mindfulness or structured intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spiritual Well-Being Score	Spiritual well-being will be measured using the Indonesian version of the Spiritual Well-Being Scale (SWBS). The SWBS assesses overall spiritual well-being through self-reported questionnaire items. Higher scores indicate better spiritual well-being. The primary outcome is the change in SWBS total score from baseline to post-intervention.	Baseline (Week 0) and after 4 weeks of intervention (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Score	Anxiety will be assessed using the Indonesian version of the Zung Self-Rating Anxiety Scale (ZSARS), a 20-item self-reported questionnaire. Higher scores indicate higher anxiety levels. The secondary outcome is the change in ZSARS total score from baseline to post-intervention.	Baseline (Week 0) and after 4 weeks of intervention (Week 4)

Collaborators and Investigators

• Sponsor: Universitas Muhammadiyah Surakarta

Publications and helpful links

General Publications

• Murwani WG, Rosyid FN, Hudiyawati D. Effect of Bedtime Meditation on Spiritual Well-Being and Anxiety in Hemodialysis Patients: A Randomized Controlled Trial. Manuscript in preparation / submitted for publication, 2025.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety Reduction; Spiritual Well-Being; Hemodialysis Patients; Bedtime Meditation; BM-BOM
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2025-BMBOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPD) with external researchers. The dataset will remain confidential and will only be accessible to the research team, in accordance with ethical approval and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No