Clinical trial NCT06864455: 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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behaviour
Psychology
Physiology
Therapy
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: European Society of Pediatric Gastroenterology, Hepatology and Nutrition
First posted: 2025-03-07
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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:

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.

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)

Primary outcomes:
measure: Heart Rate (BPM)
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Systolic Blood Pressure (SBP)
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Diastolic Blood Pressure (DBP)
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Fingertip Temperature (FT)
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Breast Milk Cortisol Level
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Perceived Relaxation (PR)
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
Secondary outcomes:
measure: Fat
timeFrame: From enrollment to the end of the 5-session intervention (within 2 weeks).
measure: Carbohydrate
timeFrame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
measure: Total energy
timeFrame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor
state: Selangor
Study officials:
References:
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citation: 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.
citation: 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.
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citation: 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.