NCT06864455 Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)
| NCT ID | NCT06864455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiti Putra Malaysia |
| Condition | Behaviour |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-09-17 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06864455 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Behaviour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864455 currently recruiting?
Yes, NCT06864455 is actively recruiting participants. Contact the research team at n_husna@upm.edu.my for enrollment information.
Where is the NCT06864455 trial being conducted?
This trial is being conducted at Serdang, Malaysia.
Who is sponsoring the NCT06864455 clinical trial?
NCT06864455 is sponsored by Universiti Putra Malaysia. The trial plans to enroll 15 participants.