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

Recruiting now · Not applicable

Conditions studied: Behaviour, Psychology, Physiology, Therapy

In brief

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

Key facts

Study ID

NCT06864455

Run by

Universiti Putra Malaysia

People needed

15

Starts

2024-09-17

Expected to finish

2026-08-21

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Taking psychiatric medication and being diagnosed with mental illness.
• Mothers are on medication that contradicts breastfeeding (eg: under medication HIV/AIDS)
• Plan to formula feed or mix feeding their infants.
• Mothers of infants with illness that could affect breastfeeding and growth (respiratory issues, gastrointestinal issues, feeding difficulties, neurological disorder, etc)

Where it is running

• Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor — Serdang, Selangor, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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