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NCT Number: NCT07795632

Sound Heart Spiritual Combined With Dhikr for Patients With Heart Failure

Heart failure can cause persistent fatigue, impaired quality of life, and spiritual distress. This interventional study will evaluate a 12-week Sound Heart Spiritual intervention combined with dhikr (SHS-Zikir) among Muslim adults with New York Heart Association functional class II or III heart failure at RSUD Kota Kendari, Indonesia. SHS-Zikir integrates structured spiritual nursing care with Islamic remembrance practices to strengthen the participant's relationship with Allah, self, other people, and the environment. The program includes guided sessions, education, home practice, family support, and daily monitoring. Spiritual well-being, fatigue, and quality of life will be assessed at baseline and at the end of the program. The findings will indicate whether SHS-Zikir can support holistic nursing care for people living with heart failure.

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Key information

Age range

23 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The SHS-Zikir intervention is based on the Sound Heart Spiritual model and integrates structured spiritual nursing care with Islamic dhikr. The intervention addresses four dimensions of spiritual relationships: the relationship with Allah, the relationship with oneself, relationships with other people, and the relationship with the environment.

The intervention is delivered over 12 weeks. Week 1 includes participant orientation, informed consent, education about SHS-Zikir, and baseline assessment of spiritual well-being, fatigue, and quality of life. During Weeks 2 through 7, participants receive structured facilitator-guided sessions addressing tauhid, tawakkal, husnuzan, the meaning of illness, gratitude, forgiveness, prayer, Qur'an recitation or listening, dhikr, family support, and appropriate self-care. During Weeks 8 through 11, participants continue independent SHS-Zikir practice at home with support and monitoring from a family member. Home activities are documented using a daily monitoring form. Week 12 includes the final assessment of spiritual well-being, fatigue, and quality of life.

The study will examine changes in participants' spiritual well-being, fatigue, and quality of life following completion of the SHS-Zikir program. The study is expected to provide evidence regarding the use of culturally and religiously appropriate spiritual nursing care for Muslim patients living with heart failure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 23 to 69 years.
  • Muslim.
  • Regularly performs obligatory Islamic worship according to their health condition.
  • Diagnosed with heart failure classified as New York Heart Association functional class II or III.
  • Heart failure primarily attributable to coronary artery disease or hypertension, as documented in the medical record and confirmed by the treating physician.
  • Receives outpatient care at the cardiology clinic of Bahteramas Regional General Hospital or Kendari City Regional General Hospital.
  • Willing and able to participate in the study and provide informed consent.

Exclusion criteria

  • Acute decompensated heart failure at the time of recruitment.
  • Acute stroke at the time of recruitment.
  • Diabetes mellitus.
  • Renal failure.
  • Verbal communication impairment that prevents participation in the intervention or completion of study assessments.
  • Hearing impairment that prevents participation in the intervention.
  • A diagnosed mental disorder that prevents informed participation or completion of the intervention.

Treatment and study plan

Sound Heart Spiritual Intervention Combined With Dhikr

Behavioral

The SHS-Zikir intervention is a 12-week structured spiritual nursing program based on the Sound Heart Spiritual model and Islamic dhikr practices. The program includes facilitator-guided spiritual sessions, education, dhikr, prayer, Qur'an recitation or listening, gratitude, forgiveness, family support, and appropriate self-care. Participants also perform independent home practice supported by a family member and document their activities using a daily monitoring form. The intervention is provided in addition to usual heart failure care.

Primary outcomes

  1. Change in Spiritual Well-Being Score

    Time frame: Baseline and Week 12

    Spiritual well-being will be assessed using the 20-item Spiritual Health and Life-Orientation Measure (SHALOM). The instrument assesses personal, communal, environmental, and transcendental domains of spiritual well-being. Each item is rated from 1 to 5. The lived-experience item scores will be summed to produce a total score ranging from 20 to 100. Higher scores indicate greater spiritual well-being. Change will be calculated as the Week 12 score minus the baseline score. A positive change indicates improvement.

Secondary outcomes

  1. Change in Fatigue Score

    Time frame: Baseline and Week 12

    Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item is rated from 1 to 5. Items 4 and 10 are reverse-scored, and the item scores are summed to produce a total score ranging from 10 to 50. Higher scores indicate greater fatigue. Change will be calculated as the Week 12 score minus the baseline score. A negative change indicates improvement or reduced fatigue.

  2. Change From Baseline in Heart Failure-Specific Quality of Life Assessed Using the MLHFQ

    Time frame: Baseline to Week 12

    Heart failure-specific quality of life will be assessed using the 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is rated from 0 to 5, and the item scores are summed to produce a total score ranging from 0 to 105. Higher scores indicate a greater negative impact of heart failure and poorer quality of life. Change will be calculated as the Week 12 score minus the baseline score. A negative change indicates improvement in quality of life.

Sponsors and collaborators

Lead sponsor

Risqi Wahyu Susanti

Other

Registry information

Official study title

Effects of the Sound Heart Spiritual Intervention Combined With Dhikr (SHS-Zikir) on Spiritual Well-Being, Fatigue, and Quality of Life in Patients With Heart Failure

Acronym: SHS-ZIKIR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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