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

NCT06864455 | Recruiting

• 2 other identifiers: JKEUPM-2024-205vot 1471
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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:
• 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?
• 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?
• Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants?
• 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

Outcome Measures

Primary Outcomes (6)

• Heart Rate (BPM)

  Pre- and post-measurement of heart rate in beats per minute (BPM).

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Systolic Blood Pressure (SBP)

  Pre- and post-measurement of systolic blood pressure in millimeters of mercury (mmHg).

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Diastolic Blood Pressure (DBP)

  Pre- and post- measurement of diastolic blood pressure in millimeters of mercury (mmHg).

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Fingertip Temperature (FT)

  Pre- and post-measurement of fingertip temperature in degrees Celsius (°C).

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Breast Milk Cortisol Level

  Pre- and post-measurement of cortisol levels in breast milk, typically expressed in nanograms per milliliter (ng/mL).

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Perceived Relaxation (PR)

  Pre- and post-measurement of perceived relaxation levels, using a 10 cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10 cm, where 0 cm (on the left) represents "completely unrelaxed" and 10 cm (on the right) represents "completely relaxed." Participants will mark a point on the scale that reflects their level of relaxation at the specified time.

  From enrollment to the end of the 5-session intervention (within 2 weeks).

Secondary Outcomes (3)

• Fat

  From enrollment to the end of the 5-session intervention (within 2 weeks).

• Carbohydrate

  Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)

• Total energy

  Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)

Study Arms (5)

Guided Imagery Meditation

EXPERIMENTAL

Participants will need to listen to the guided imagery meditation tape that was developed by Sheri Menelli in 2004 for breastfeeding mothers as it has been successfully used before.

Behavioral: Guided Imagery Meditation

Religious Recitation

EXPERIMENTAL

-Participants will need to listen to Surah Ar-Rahman, which will be used in this study since it has been done previously among pregnant women in the labour process.

Behavioral: Religious Recitation

Infant Video with Music

EXPERIMENTAL

The video will be played for 10 minutes duration and mothers will need to hold the phone to look at the slide show of their infant's image and video that will be recorded by the researcher prior session

Behavioral: Infant Video with Music

Distraction with News and Media

EXPERIMENTAL

The researcher will instruct mothers to use their phones as they did at home for 10 minutes to measure how this distraction affects the mother's physiology and psychology.

Behavioral: Distraction with News and Media

Control

EXPERIMENTAL

No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied.

Behavioral: Control

Interventions

Guided Imagery Meditation BEHAVIORAL

Audio meditation by Sheri Menelli, for 10-14minutes

Guided Imagery Meditation

Religious Recitation BEHAVIORAL

listen to Surah Ar-Rahman for 14 minutes

Religious Recitation

Infant Video with Music BEHAVIORAL

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

Infant Video with Music

Distraction with News and Media BEHAVIORAL

10 minutes of phone use

Distraction with News and Media

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Malaysian women of reproductive age (18-49 years)
• Muslim
• Non-smoker
• Understand English or Malay
• Currently breastfeed their infants
• Mothers of infants born in gestational age (28 weeks- 35 weeks)
• No medical conditions that can affect infant feeding.

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)

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• European Society of Pediatric Gastroenterology, Hepatology and Nutrition: collaborator

Study Sites (1)

Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor

Serdang, Selangor, 43400, Malaysia

RECRUITING

Related Publications (10)

• Yu J, Wells J, Wei Z, Fewtrell M. 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. Int Breastfeed J. 2019 Dec 16;14:50. doi: 10.1186/s13006-019-0246-5. eCollection 2019.

  PMID: 31889973 BACKGROUND

• Yu J, Wells J, Wei Z, Fewtrell M. Randomized Trial Comparing the Physiological and Psychological Effects of Different Relaxation Interventions in Chinese Women Breastfeeding Their Healthy Term Infant. Breastfeed Med. 2019 Jan/Feb;14(1):33-38. doi: 10.1089/bfm.2018.0148. Epub 2018 Oct 23.

  PMID: 30351172 BACKGROUND

• Mohd Shukri NH, Wells JCK, Fewtrell M. The effectiveness of interventions using relaxation therapy to improve breastfeeding outcomes: A systematic review. Matern Child Nutr. 2018 Apr;14(2):e12563. doi: 10.1111/mcn.12563. Epub 2017 Nov 6.

  PMID: 29105966 BACKGROUND

• Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.

  PMID: 31161202 BACKGROUND

• Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z.

  PMID: 28900859 BACKGROUND

• Nomkin LG, Gordon I. The relationship between maternal smartphone use, physiological responses, and gaze patterns during breastfeeding and face-to-face interactions with infant. PLoS One. 2021 Oct 8;16(10):e0257956. doi: 10.1371/journal.pone.0257956. eCollection 2021.

  PMID: 34624025 BACKGROUND

• Keith DR, Weaver BS, Vogel RL. 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. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842.

  PMID: 22469966 BACKGROUND

• Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.

  PMID: 26023551 BACKGROUND

• Dib S, Wells JCK, Fewtrell M. A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women. PeerJ. 2020 May 22;8:e9217. doi: 10.7717/peerj.9217. eCollection 2020.

  PMID: 32509467 BACKGROUND

• Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.

  PMID: 26495909 BACKGROUND

MeSH Terms

Conditions

Behavior

Interventions

Culture Media

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Central Study Contacts

Dr Nurul Husna Mohd Shukri

CONTACT

+603-97692963; n_husna@upm.edu.my

Nazratul Fareha Azman

CONTACT

+60134974704; gs67689@student.edu.upm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: It is a "within-subject randomized trial" is a type of experimental study where each individual is exposed to more than one treatment. In this design, each participant acts as their own control, which helps to control for individual differences and reduces variability.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: March 7, 2025
• Study Start: September 17, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 21, 2026
• Last Updated: March 7, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)