AzTrials
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Chronic Kidney DiseaseBM-BOMNCT07378748

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

A study testing Bedtime Meditation Based on Mindfulness (BM-BOM) in people with Chronic Kidney Disease and Hemodialysis, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease, Hemodialysis, Anxiety
What is being tested?
Bedtime Meditation Based on Mindfulness (BM-BOM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteIndonesia
Study dates
1 Jun 2025to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • UNS Hospital

    Surakarta, Centre Java, 57126

Other trials in Indonesia

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Bedtime Meditation Based on Mindfulness (BM-BOM), Passive Rest (Control)
Keywords
Bedtime Meditation, Spiritual Well-Being, Hemodialysis Patients, Anxiety Reduction, BM-BOM
Medical subject headings
Renal Insufficiency, Chronic, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bedtime Meditation Based on Mindfulness (BM-BOM)Behavioural

    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.

  • Passive Rest (Control)Behavioural

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

Study groups in NCT07378748
Study groupRoleWhat they receive
BM-BOM Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Bedtime Meditation Based on Mindfulness (BM-BOM)
Control Group (Passive Rest)Active comparatorParticipants 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
Receives: Behavioral: Passive Rest (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start1 Jun 2025
  3. Primary completion30 Jul 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378748
Sponsor's protocol ID
2025-BMBOM
Acronym
BM-BOM
Status last verified
Jan 2026
First submitted
23 Jan 2026
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Bedtime Meditation Based on Mindfulness (BM-BOM) in people with Chronic Kidney Disease and Hemodialysis, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Spiritual Well-Being Score (time frame: Baseline (Week 0) and after 4 weeks of intervention (Week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07378748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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