NCT07405593

Brief Summary

This study aims to evaluate the effects of a combination of a 30-degree head-up position and murottal therapy on physiological and symptom outcomes in stroke patients. The intervention is expected to influence blood pressure, pulse rate, respiratory rate, pain level, and the incidence of projectile vomiting. Stroke patients will receive standard care with the addition of the combined intervention. The results of this study may support non-pharmacological nursing interventions to improve patient comfort and clinical stability.

Trial Health

63
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Trial Health Score

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

Enrollment
112

participants targeted

Target at P75+ for not_applicable stroke

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable stroke

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

Study Progress88%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

January 26, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
17 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

Expected
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 26, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Head UpMurottal Therapy

Outcome Measures

Primary Outcomes (5)

  • Blood Pressure

    Change in systolic and diastolic blood pressure from baseline to after completion of the 3-day intervention.

    Baseline and after completion of the 3-day intervention

  • Pulse Rate

    Change in pulse rate from baseline to after completion of the 3-day intervention.

    Baseline and after completion of the 3-day intervention

  • Respiratory Rate

    Change in respiratory rate from baseline to after completion of the 3-day intervention

    Baseline and after completion of the 3-day intervention

  • Pain Degree

    Change in pain score measured using the Critical-Care Pain Observation Tool (CPOT; range 0-8), where higher scores indicate more severe pain, from baseline to after completion of the 3-day intervention.

    Baseline and after completion of the 3-day intervention

  • Projectile Vomiting

    Change in nausea and vomiting severity measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR; range 0-32), where higher scores indicate more severe symptoms, from baseline to after completion of the 3-day intervention.

    Baseline and after completion of the 3-day intervention

Study Arms (2)

Combination of 30-Degree Head-Up Positioning and Murottal Therapy

EXPERIMENTAL

Participants receive a combination of 30-degree head-up positioning and murottal therapy in addition to standard nursing care during the intervention period.

Other: Combination of 30 Degree Head Up and Murottal Therapy

Standard Care

ACTIVE COMPARATOR

Participants receive standard nursing care according to the hospital's clinical protocol without the addition of head-up positioning or murottal therapy.

Other: Standard Care (in control arm)

Interventions

Participants in this group received a combination of two non-pharmacological interventions during the study period. First, participants were positioned with their heads elevated at a 30-degree angle while lying in bed to support physiological stability, including monitoring of blood pressure, pulse rate, respiratory rate, pain level, and projectile vomiting. Second, participants listened to Quranic recitation (murottal therapy) via audio recording in a quiet environment. Both interventions were administered simultaneously. Intervention sessions lasted 30 minutes for 3 days (a consistent duration and frequency for all participants in this group). Outcomes such as vital signs, pain level, and episodes of severe vomiting were monitored before and after the intervention period.

Combination of 30-Degree Head-Up Positioning and Murottal Therapy

Participants in this arm receive standard nursing care according to the hospital protocol without additional head-up positioning or murottal therapy. Standard care includes routine monitoring of vital signs, medication administration, and basic supportive nursing interventions.

Standard Care

Eligibility Criteria

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

You may qualify if:

  • Patients with a medical diagnosis of stroke (hemorrhagic and non-hemorrhagic).
  • Patients with systolic blood pressure above 150 mmHg.
  • Somnolence (GCS ≥ 9).
  • Muslim.
  • Patients without hearing impairment.
  • Willingness to participate and sign informed consent.

You may not qualify if:

  • Patients who are non-Muslim.
  • Patients with decreased consciousness (GCS \< 9).
  • Patients with heart problems.
  • Patients with psychiatric disorders.
  • Patients receiving sedative therapy during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Indriati Solo Baru

Sukoharjo, Central Java, 57571, Indonesia

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Fila Diana Nurhayati, S.Kep.,Ns

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This study is conducted as an open-label trial because the non-pharmacological interventions, including 30-degree head-up positioning and murottal therapy, are clearly observable and cannot be feasibly blinded to participants, care providers, or investigators.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are assigned in parallel to an intervention group receiving 30-degree head-up positioning and murottal therapy or to a control group receiving standard care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Researcher

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 12, 2026

Study Start

March 1, 2026

Primary Completion

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations