Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)
NCT ID: NCT06864455
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-09-17
2026-08-21
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Guided Imagery Meditation
Audio meditation by Sheri Menelli, for 10-14minutes
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.
Religious Recitation
listen to Surah Ar-Rahman for 14 minutes
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
Infant Video with Music
10 minutes of slides show of infant's image and video
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.
Distraction with News and Media
10 minutes of phone use
Control
No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied.
Control
All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.
Interventions
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Guided Imagery Meditation
Audio meditation by Sheri Menelli, for 10-14minutes
Religious Recitation
listen to Surah Ar-Rahman for 14 minutes
Infant Video with Music
10 minutes of slides show of infant's image and video
Distraction with News and Media
10 minutes of phone use
Control
All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
49 Years
FEMALE
Yes
Sponsors
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European Society of Pediatric Gastroenterology, Hepatology and Nutrition
OTHER
Universiti Putra Malaysia
OTHER
Responsible Party
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Nurul Husna Binti Mohd Shukri
Principle Investigator
Locations
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Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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vot 1471
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
JKEUPM-2024-205
Identifier Type: -
Identifier Source: org_study_id
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