Heart FailureSHS-ZIKIRNCT07795632
Sound Heart Spiritual Combined With Dhikr for Patients With Heart Failure
A study testing Sound Heart Spiritual Intervention Combined With Dhikr in people with Heart Failure, run by Risqi Wahyu Susanti.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 23 to 69 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sound Heart Spiritual Intervention Combined With Dhikr
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 23 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Sound Heart Spiritual Intervention Combined With Dhikr
- Keywords
- Sound Heart Spiritual, Dhikr, Islamic Spiritual Care, Spiritual Well-Being, Fatigue, Quality of Life, Muslim Patients With Heart Failure, Fatigue Assessment Scale, SHS-Zikir
- Medical subject headings
- Heart Failure, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Heart Spiritual Intervention Combined With DhikrBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SHS-Zikir Intervention | Experimental | Participants will receive the 12-week Sound Heart Spiritual intervention combined with dhikr (SHS-Zikir) in addition to usual heart failure care. The program includes structured facilitator-guided spiritual sessions, Islamic dhikr, education, home practice, family support, and daily monitoring. Weeks 8 through 11 emphasize independent home practice with family monitoring. Outcomes will be assessed at baseline and at the end of Week 12. Receives: Behavioral: Sound Heart Spiritual Intervention Combined With Dhikr |
| Usual Care Control | No intervention | Participants will continue to receive the usual medical and nursing care provided by the cardiology clinic. They will not receive the structured SHS-Zikir program during the 12-week study period. Spiritual well-being, fatigue, and quality of life will be assessed at baseline and at the end of Week 12. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spiritual Well-Being Score
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.
Measured: Baseline and Week 12
Secondary outcomes (2)
Change in Fatigue Score
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.
Measured: Baseline and Week 12
Change From Baseline in Heart Failure-Specific Quality of Life Assessed Using the MLHFQ
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Risqi Wahyu Susanti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Risqi Wahyu Susanti, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795632
- Sponsor's protocol ID
- 183/KEPK-IAKMI/IX/2025
- Other IDs
- NIB 202404121496
- Acronym
- SHS-ZIKIR
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07795632
- Acronym / sponsor ID
- SHS-ZIKIR / 183/KEPK-IAKMI/IX/2025
- Conditions
- Heart Failure
- Keywords
- Sound Heart Spiritual, Dhikr, Islamic Spiritual Care, Spiritual Well-Being, Fatigue, Quality of Life, Muslim Patients With Heart Failure, Fatigue Assessment Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Risqi Wahyu SusantiUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHS-Zikir Intervention | Experimental | Behavioral: Sound Heart Spiritual Intervention Combined With DhikrParticipants will receive the 12-week Sound Heart Spiritual intervention combined with dhikr (SHS-Zikir) in addition to usual heart failure care. The program includes structured facilitator-guided spiritual sessions, Islamic dhikr, education, home practice, family support, and daily monitoring. Weeks 8 through 11 emphasize independent home practice with family monitoring. Outcomes will be assessed at baseline and at the end of Week 12. |
| Usual Care Control | No intervention | –Participants will continue to receive the usual medical and nursing care provided by the cardiology clinic. They will not receive the structured SHS-Zikir program during the 12-week study period. Spiritual well-being, fatigue, and quality of life will be assessed at baseline and at the end of Week 12. |
Who may qualify
- Ages
- 23 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound Heart Spiritual Intervention Combined With DhikrThe 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. | Behavioural | SHS-Zikir Intervention |
Primary outcome
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.
2 secondary outcomes
Change in Fatigue Score
Time frame: Baseline and Week 12
Change From Baseline in Heart Failure-Specific Quality of Life Assessed Using the MLHFQ
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Heart Spiritual Intervention Combined With Dhikr in people with Heart Failure, run by Risqi Wahyu Susanti.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.