Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
NCT06864455

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

Led by Universiti Putra Malaysia · Updated on 2025-03-07

15

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

U

Universiti Putra Malaysia

Lead Sponsor

E

European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Malaysian women aged 18 to 49 years
  • Muslim
  • Non-smokers
  • Understand English or Malay
  • Currently breastfeeding their infants
  • Mothers of infants born between 28 and 35 weeks gestation
  • No medical conditions affecting infant feeding
Not Eligible

You will not qualify if you...

  • Taking psychiatric medications or diagnosed with mental illness
  • On medications that contradict breastfeeding (e.g., HIV/AIDS treatment)
  • Planning to formula feed or mix feed their infants
  • Mothers of infants with illnesses affecting breastfeeding or growth (respiratory, gastrointestinal, neurological, feeding difficulties)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor

Serdang, Selangor, Malaysia, 43400

Actively Recruiting

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Research Team

D

Dr Nurul Husna Mohd Shukri

CONTACT

N

Nazratul Fareha Azman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

5

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