Clinical Trial

Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)

Recruiting
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Record status
This record was last updated March 7, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is designed to compare the effects of four relaxation interventions on both physiological and psychological outcomes in lactating mothers of preterm infants. The interventions being tested include: * Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session The primary objectives of the study are to evaluate and compare how these different relaxation techniques influence the physiological and psychological well-being of mothers and identify which intervention is most effective for lactating mothers who deliver prematurely. The main research questions are: 1. How do different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) affect physiological and psychological outcomes when measured within the same participants? 2. Are there significant differences in physiological and psychological outcomes when participants are exposed to different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) within the same group? 3. Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants? Study Design: Each participant will be exposed to five different sessions (one for each intervention), with a gap of 1-2 days between sessions. The interventions will be administered as follows: * Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session Expected Outcomes: This study will assess the following physiological and psychological outcomes: Physiological changes: * Heart Rate (HR) * Systolic Blood Pressure (SBP) * Diastolic Blood Pressure (DBP) * Fingertip Temperature (FT) * Breast milk cortisol concentration Psychological changes: •. Perceived Relaxation
Trial Details
NCT Number NCT06864455
Lead Sponsor Universiti Putra Malaysia
Collaborators: European Society of Pediatric Gastroenterology, Hepatology and Nutrition
Conditions Behaviour, Psychology, Physiology, Therapy
Enrollment 15 participants
Start Date 2024-09-17
Primary Completion 2025-08-31 (estimated)
Study Completion 2026-08-21 (estimated)
Updated on ClinicalTrials.gov 2025-03-07