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

Official title

"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"

Overview

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

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.

Interventions

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

Primary outcome measures

• Heart Rate (BPM) [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Systolic Blood Pressure (SBP) [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Diastolic Blood Pressure (DBP) [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Fingertip Temperature (FT) [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Breast Milk Cortisol Level [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Perceived Relaxation (PR) [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]

Secondary outcome measures (3)

• Fat [Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).]
• Carbohydrate [Time frame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)]
• Total energy [Time frame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

Malaysia · 1 center

• Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor — Serdang

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06864455 · JKEUPM-2024-205 · vot 1471

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗