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

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

Conditions

• Behaviour
• Psychology
• Physiology
• Therapy

Interventions

BEHAVIORAL

Guided Imagery Meditation

Audio meditation by Sheri Menelli, for 10-14minutes

BEHAVIORAL

Religious Recitation

listen to Surah Ar-Rahman for 14 minutes

BEHAVIORAL

Infant Video with Music

10 minutes of slides show of infant's image and video

BEHAVIORAL

Distraction with News and Media

10 minutes of phone use

BEHAVIORAL

Control

All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.

Sponsors & Collaborators

• European Society of Pediatric Gastroenterology, Hepatology and Nutrition

  collaborator OTHER

• Universiti Putra Malaysia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-17

Primary Completion

2025-08-31

Completion

2026-08-21

Countries

• Malaysia

Study Locations