[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582526":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":39,"centralContacts":52,"locations":62,"responsibleParty":82,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":39,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":39,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":39,"overallStatus":65,"whyStopped":39,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Universiti Putra Malaysia","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Guided Imagery Meditation","EXPERIMENTAL","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.",[13],"Behavioral: Guided Imagery Meditation",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Behavioral: Religious Recitation",{"label":20,"type":10,"description":21,"interventionNames":22},"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",[23],"Behavioral: Infant Video with Music",{"label":25,"type":10,"description":26,"interventionNames":27},"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.",[28],"Behavioral: Distraction with News and Media",{"label":30,"type":10,"description":31,"interventionNames":32},"Control","No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied.",[33],"Behavioral: Control",[35,40,43,46,49],{"type":36,"name":9,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Audio meditation by Sheri Menelli, for 10-14minutes",[9],null,{"type":36,"name":15,"description":41,"armGroupLabels":42,"otherNames":39},"listen to Surah Ar-Rahman for 14 minutes",[15],{"type":36,"name":20,"description":44,"armGroupLabels":45,"otherNames":39},"10 minutes of slides show of infant's image and video",[20],{"type":36,"name":25,"description":47,"armGroupLabels":48,"otherNames":39},"10 minutes of phone use",[25],{"type":36,"name":30,"description":50,"armGroupLabels":51,"otherNames":39},"All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.",[30],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":39,"email":57},"Dr Nurul Husna Mohd Shukri","CONTACT","+603-97692963","n_husna@upm.edu.my",{"name":59,"role":55,"phone":60,"phoneExt":39,"email":61},"Nazratul Fareha Azman","+60134974704","gs67689@student.edu.upm.my",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor","RECRUITING","Serdang","Selangor","43400","Malaysia","MY",{"type":72,"coordinates":73},"Point",[74,75],101.71667,3.03333,{"lat":75,"lon":74},[78],{"name":79,"role":55,"phone":80,"phoneExt":39,"email":81},"Dr Zurina Zainuddin Dr Zurina Zainuddin","+603-9769261","zaizurina@upm.edu.my",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Nurul Husna Binti Mohd Shukri","Principle Investigator",[87],{"name":88,"class":6},"European Society of Pediatric Gastroenterology, Hepatology and Nutrition","100582526","breastfeeding-relaxation-intervention-among-mothers-of-preterm-infants-in-hospital-sultan-abdul-aziz-shah-hsaas-100582526",false,"NCT06864455","Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)","\"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\"","Inclusion Criteria ( Mothers)\n\n* Malaysian women of reproductive age (18-49 years)\n* Muslim\n* Non-smoker\n* Understand English or Malay\n* Currently breastfeed their infants\n* Mothers of infants born in gestational age (28 weeks- 35 weeks)\n* No medical conditions that can affect infant feeding.\n\nExclusion Criteria:\n\n* Taking psychiatric medication and being diagnosed with mental illness.\n* Mothers are on medication that contradicts breastfeeding (eg: under medication HIV\u002FAIDS)\n* Plan to formula feed or mix feeding their infants.\n* Mothers of infants with illness that could affect breastfeeding and growth (respiratory issues, gastrointestinal issues, feeding difficulties, neurological disorder, etc)",true,"FEMALE","18 Years","49 Years",{"count":101,"type":102},15,"ESTIMATED","INTERVENTIONAL",[105],"NA","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:\n\n* Guided Imagery Meditation (GIM)\n* Religious Recitation (RR)\n* Infant Video with Music\n* Distraction with News and Media\n* A Control session\n\nThe 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.\n\nThe main research questions are:\n\n1. 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?\n2. 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?\n3. Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants?\n\nStudy Design:\n\nEach 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:\n\n* Guided Imagery Meditation (GIM)\n* Religious Recitation (RR)\n* Infant Video with Music\n* Distraction with News and Media\n* A Control session\n\nExpected Outcomes:\n\nThis study will assess the following physiological and psychological outcomes:\n\nPhysiological changes:\n\n* Heart Rate (HR)\n* Systolic Blood Pressure (SBP)\n* Diastolic Blood Pressure (DBP)\n* Fingertip Temperature (FT)\n* Breast milk cortisol concentration\n\nPsychological changes:\n\n•. Perceived Relaxation",[108,109,110,111],"Behaviour","Psychology","Physiology","Therapy","2025-03-03",{"date":114,"type":115},"2025-03-07","ACTUAL",{"date":117,"type":115},"2024-09-17",{"date":119,"type":102},"2026-08-21",{"name":5,"class":6},1]