Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
ID06864455

Effects of a Relaxation Intervention on Physiological and Psychological Outcomes Among Mothers of Preterm Infants at Hospital Sultan Abdul Aziz Shah: a Within-subject Randomized Trial

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

15

Participants Needed

1

Research Sites

50 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

Researchers are studying the effects of four different relaxation techniques on the physical and mental well-being of mothers who are breastfeeding preterm infants. This study focuses on mothers of premature babies born between 28 and 35 weeks gestation, aiming to see how each intervention influences heart rate, blood pressure, fingertip temperature, breast milk cortisol levels, and feelings of relaxation. The goal is to identify which relaxation method works best for this group. The study involves five sessions per participant, each testing a different approach: Guided Imagery Meditation, Religious Recitation, Infant Video with Music, Distraction with News and Media, and a Control session with minimal activity. Each session lasts about 10 to 14 minutes and is spaced 1 to 2 days apart. Participants will experience all five interventions in a randomized order to compare effects within the same mothers. During the study, mothers will have their heart rate, blood pressure, fingertip temperature, and breast milk cortisol measured before and after each session. They will also report their perceived relaxation levels. The study will last about two weeks from enrollment through the completion of all five sessions. Additional measures include breast milk fat, carbohydrate, and total energy content. This research is led by Universiti Putra Malaysia and focuses on Muslim mothers who are non-smokers and currently breastfeeding.

CONDITIONS

Brief 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-smoker
  • 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 medication or diagnosed with mental illness
  • On medication that contradicts breastfeeding (e.g., for HIV/AIDS)
  • Planning to formula feed or mix feed infants
  • Mothers of infants with illnesses affecting breastfeeding and growth (respiratory, gastrointestinal, feeding difficulties, neurological disorders, etc.)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Within 2 weeks

Participants receive five different relaxation interventions in a randomized order, including guided imagery meditation, religious recitation, infant video with music, distraction with news and media, and a control condition. Each intervention session lasts about 10 to 14 minutes and is completed within 2 weeks.

5 sessions

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

N

Nazratul Fareha Azman

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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Published Research Related To This Trial

Effects of relaxation therapy on maternal psychological state, infant growth and gut microbiome: protocol for a randomised controlled trial investigating mother-infant signalling during lactation following late preterm and early term delivery.

Jinyue Yu, Jonathan Wells, Zhuang Wei...

https://pubmed.ncbi.nlm.nih.gov/31889973

Randomized Trial Comparing the Physiological and Psychological Effects of Different Relaxation Interventions in Chinese Women Breastfeeding Their Healthy Term Infant.

Jinyue Yu, Jonathan Wells, Zhuang Wei...

https://pubmed.ncbi.nlm.nih.gov/30351172

The effectiveness of interventions using relaxation therapy to improve breastfeeding outcomes: A systematic review.

Nurul Husna Mohd Shukri, Jonathan C K Wells, Mary Fewtrell

https://pubmed.ncbi.nlm.nih.gov/29105966

Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth.

Nurul Husna Mohd Shukri, Jonathan Wells, Simon Eaton...

https://pubmed.ncbi.nlm.nih.gov/31161202

The relationship between maternal smartphone use, physiological responses, and gaze patterns during breastfeeding and face-to-face interactions with infant.

Lilach Graff Nomkin, Ilanit Gordon

https://pubmed.ncbi.nlm.nih.gov/34624025

The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants.

Douglas R Keith, Barbara S Weaver, Robert L Vogel

https://pubmed.ncbi.nlm.nih.gov/22469966

A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women.

Sarah Dib, Jonathan C K Wells, Mary Fewtrell

https://pubmed.ncbi.nlm.nih.gov/32509467