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NCT06864455
Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)
NA trial testing Guided Imagery Meditation in Behaviour in 15 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | Universiti Putra Malaysia |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 15 |
| Start date | 17 September 2024 |
| Primary completion | 31 August 2025 |
| Estimated completion | 21 August 2026 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Guided Imagery Meditation
- Religious Recitation
- Infant Video with Music
- Distraction with News and Media
- Control
Conditions studied
- Behaviour — all drugs for Behaviour →
- Psychology — all drugs for Psychology →
- Physiology — all drugs for Physiology →
- Therapy — all drugs for Therapy →
Sponsor
Universiti Putra Malaysia — full company profile →
Who can join
Adults 18 to 49, female only, with Behaviour or Psychology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06864455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universiti Putra Malaysia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06864455 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiti Putra Malaysia
- Last refreshed: 7 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06864455.
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