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

NCT07378748 | Completed

• 1 other identifier: 2025-BMBOM
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Spiritual Well-being; Chronic Kidney Disease; Hemodialysis

Keywords

Bedtime Meditation; Spiritual Well-Being; Hemodialysis Patients; Anxiety Reduction; BM-BOM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Anxiety Score

  Baseline (Week 0) and after 4 weeks of intervention (Week 4)

Study Arms (2)

BM-BOM Intervention Group

EXPERIMENTAL

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)

Control Group (Passive Rest)

ACTIVE COMPARATOR

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)

Interventions

Bedtime Meditation Based on Mindfulness (BM-BOM) BEHAVIORAL

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.

BM-BOM Intervention Group

Passive Rest (Control) BEHAVIORAL

Participants rested quietly with eyes closed for approximately 15 minutes during hemodialysis sessions without any guided mindfulness or structured intervention.

Control Group (Passive Rest)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

Study Sites (1)

UNS Hospital

Surakarta, Centre Java, 57126, Indonesia

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study used a single-blind design in which participants were blinded to their group allocation. Outcome assessment was conducted using self-reported questionnaires
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ners.

Model Details: Participants were randomly assigned to two parallel groups: an intervention group receiving Bedtime Meditation Based on Mindfulness (BM-BOM) and a control group receiving passive rest without guided mindfulness. Outcomes were measured at baseline and after four weeks of intervention.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: June 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)