NCT07412548

Brief Summary

This quasi-experimental study aims to evaluate the effect of combined autogenic relaxation and Surah Ar-Rahman murottal therapy on anxiety, sleep quality, and hemodynamic parameters in hemodialysis patients. A pretest-posttest control group design will be used involving 76 participants undergoing routine hemodialysis. Participants will be assigned to an intervention group receiving structured autogenic relaxation followed by murottal therapy and a control group receiving standard care with music listening. Anxiety, sleep quality, and hemodynamic parameters will be measured at baseline and after a 6-week intervention period. The findings are expected to support the use of non-pharmacological and spiritual-based interventions in improving psychological and physiological outcomes in hemodialysis patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 27, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Autogenic RelaxationMurottal TherapyAnxietySleep QualityHemodynamics

Outcome Measures

Primary Outcomes (4)

  • Anxiety

    Change in anxiety level measured using the Zung Self-Rating Anxiety Scale (ZSAS; range 20-80), where higher scores indicate greater anxiety, from baseline to after completion of the 6-week intervention.

    Baseline and after completion of the 6-week intervention

  • Sleep Quality

    Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21), where higher scores indicate poorer sleep quality, from baseline to after completion of the 6-week intervention.

    Baseline and after completion of the 6-week intervention.

  • Blood Presure

    Change in systolic blood pressure (mmHg), measured using a calibrated digital sphygmomanometer, from baseline to after completion of the 6-week intervention.

    Baseline and after completion of the 6-week intervention

  • Heart Rate

    Change in heart rate (beats per minute, bpm), measured using a digital bedside patient monitor, from baseline to after completion of the 6-week intervention.

    Baseline and after completion of the 6-week intervention

Study Arms (2)

Autogenic Relaxation and Murottal Therapy Surah Ar-Rahman

EXPERIMENTAL

Participants in this group receive structured autogenic relaxation followed by Surah Ar-Rahman murottal therapy during hemodialysis sessions. The intervention is administered twice weekly for six weeks, with each session lasting 10-15 minutes. The procedure is conducted by trained nurses under researcher supervision in a quiet and comfortable environment.

Behavioral: Autogenic Relaxation and Surah Ar-Rahman Murottal Therapy

Standard Care

ACTIVE COMPARATOR

listening to dangdut music for 10 to 15 minutes within 6 weeks

Other: listening to dangdut music

Interventions

A structured non-pharmacological intervention consisting of autogenic relaxation techniques including breathing regulation, muscle relaxation, and self-suggestion, followed by listening to Surah Ar-Rahman murottal recitation using earphones. Each session lasts 10-15 minutes and is conducted twice weekly for six weeks during routine hemodialysis.

Autogenic Relaxation and Murottal Therapy Surah Ar-Rahman

listening to dangdut music for 10 to 15 minutes within 6 weeks

Standard Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with stage V chronic kidney disease.
  • Undergoing scheduled hemodialysis at least twice a week for 6 weeks.
  • Outpatients and aged 18-65 years.
  • Muslim.
  • Cooperative and able to communicate verbally.
  • Willing to be a respondent by signing an informed consent form.

You may not qualify if:

  • Having a severe heart condition or an unstable critical condition.
  • Having a severe psychiatric disorder (schizophrenia, major depression).
  • Having a cognitive, hearing, or speech disorder that impedes communication.
  • Taking antidepressants, anxiolytics, or neuroleptics that may affect psychological measurement results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indriati Hospital

Sukoharjo, Central Java, 57552, Indonesia

Location

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicAnxiety DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Dyan Kurniasari, S.Kep.,Ns

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment quasi-experimental pretest-posttest control group design. Participants are assigned into two groups: an intervention group receiving structured autogenic relaxation combined with Surah Ar-Rahman murottal therapy, and a control group receiving standard hemodialysis care with music listening. Both groups undergo baseline (pretest) and post-intervention (posttest) assessments of anxiety, sleep quality, and hemodynamic parameters. The intervention is administered twice weekly for six weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Researcher

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion

May 31, 2026

Study Completion

June 30, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations