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

"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 Trials"

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

Study Overview

• Status: Recruiting
• Conditions: Therapy; Physiology; Behaviour; Psychology
• Intervention / Treatment: Behavioral: Guided Imagery Meditation; Behavioral: Religious Recitation; Behavioral: Infant Video with Music; Behavioral: Distraction with News and Media; Behavioral: Control

Detailed Description

The trial aims to recruit 30 mothers of premature infants who are born between 28 and 35 weeks, which falls under the categories of early and mid-preterm. Participants will be recruited among mothers aged between 18 and 49 who are non-smokers, with no medical condition that could affect breastfeeding, and also those who are not taking any psychiatric medication, and those who are not diagnosed with mental illness. This trial also aims to recruit Muslim mothers, since one of the interventions is Religious Recitation which focuses on Qur'anic verses.

The participants will be identified through recent hospital data on premature infants born between 28 to 35 weeks gestation and through a face-to-face approach. The study information sheet will be given to interested mothers. Eligible mothers will be given consent forms after assessing the inclusion and exclusion criteria for mothers and infants. The participants will be enrolled in the study and randomized using a computerized random number generator, where the participants cannot choose which intervention to test first. One person who had no contact with the participants will do randomization five times for each participant since four interventions and controls were involved.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Nurul Husna Mohd Shukri; Phone Number: +603-97692963; Email: n_husna@upm.edu.my
• Study Contact Backup: Name: Nazratul Fareha Azman; Phone Number: +60134974704; Email: gs67689@student.edu.upm.my

Study Locations

• Malaysia
  • Selangor
    • Serdang, Selangor, Malaysia, 43400
      • Recruiting
      • Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor
      • Contact: Dr Zurina Zainuddin Dr Zurina Zainuddin; Phone Number: +603-9769261; Email: zaizurina@upm.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria ( Mothers)

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Imagery Meditation; 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; Audio meditation by Sheri Menelli, for 10-14minutes
Experimental: Religious Recitation; -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; listen to Surah Ar-Rahman for 14 minutes
Experimental: Infant Video with Music; 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; 10 minutes of slides show of infant's image and video
Experimental: Distraction with News and Media; 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; 10 minutes of phone use
Experimental: Control; No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied.	Behavioral: Control; All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat	Pre- and post- measurement of milk fat content in grams per 100 milliliters (g/100 mL)	From enrollment to the end of the 5-session intervention (within 2 weeks).
Carbohydrate	Pre- and post- measurement of milk carbohydrate content in grams per 100 milliliters (g/100 mL).	Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Total energy	Pre- and post-measurement of total energy content in kilocalories per 100 milliliters (kcal/100 mL)	Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 21, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JKEUPM-2024-205; vot 1471 (Other Grant/Funding Number: The European Society for Paediatric Gastroenterology Hepatology and Nutrition)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study results, including aggregated data, will be shared to contribute to broader scientific understanding. However, due to privacy and confidentiality concerns, individual participant data will not be shared. Only de-identified, summary-level data (e.g., group results, statistical analyses) will be made available to the public or other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No