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IRCT20250722066597N1 IRCT 2025-08-08 Khoram-Abad University of Medical Sciences The effect of kangaroo care of premature infants on mothers The effect of kangaroo care for premature infants at home on mothers’ resilience, competence and self-efficacy 2025-08-23 anticipated 60 Complete https://irct.ir/trial/85110 observational Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, participants will be enrolled until the sample size is completed, based on the inclusion and exclusion criteria. To standardize the distribution of confounding variables such as gender, birth weight, and infant feeding, strata will be created according to these variables as follows: groups by gender (male/female), birth weight (<2000 g / 2000-2500 g), and feeding method (formula feeding / breastfeeding). Then, using block randomization, participants will be assigned to the intervention and control groups. In the present study, to balance the number of samples allocated to each study group, block randomization will be employed. For this purpose, random blocks of size 4 will be used to allocate participants to the two groups. Six different combinations of 4-sized blocks (AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be created and randomly selected using the Blockrand package in R software. The random sequence will be formed as a series of letters A and B. N/A The effect of kangaroo care for premature infants at home on mothers’ resilience, competence and self-efficacy. Intervention group: After the infant’s condition stabilizes and they are transferred from the NICU to the neonatal ward, kangaroo care training for the mother will be provided face-to-face by the researcher using pamphlets and videos for the intervention group. To ensure correct maternal performance, practical kangaroo care will be demonstrated by the mother before discharge. The special kangaroo care clothing prepared by the researcher will also be given to the mothers in the intervention group prior to discharge. The intervention will continue at home with weekly virtual and phone follow-ups for four weeks after discharge. Mothers will perform kangaroo care for their infants at home twice daily, at scheduled times after feeding and diaper changes, wearing the special clothing, positioning themselves and the infant properly, and maintaining room temperature to prevent infant hypothermia. Each session will last 30 minutes and continue for four weeks. Yes - There is a plan to make this available What will be shared: The de-identified personal data file of participants includes maternal and infant demographic information, scores on the resilience, parenting competence, and self-efficacy questionnaires, and kangaroo care outcomes. Only data related to the primary outcomes of the study will be shared after removing any personally identifiable information. When: Access to data and documentation will begin 6 months after the publication of the study results and the publication of the related article in scientific journals and will be maintained for at least five years. To whom: Researchers working at accredited academic and research institutions, as well as independent researchers pursuing research projects related to maternal and newborn health, can apply to receive data. Applicants must document their scientific identity. Conditions: The data are only allowed to be used for scientific and ethical research purposes. Any commercial or unethical use is prohibited. Applicants must submit their research protocol and sign a confidentiality and non-disclosure agreement. Where to obtain: Applicants can apply by sending a formal application via email to faezehkornokar@gmail.com. How to obtain: Upon receipt, requests will be reviewed by the research team and, if complete and in accordance with ethical and scientific standards, will be responded to within a maximum of 4 weeks. If approved, a data use agreement will be sent and, after signing it, access to the information will be provided. Comments: All data has been completely de-identified before submission. Data use is subject to compliance with privacy and research ethics laws. Previous applicants will be notified if data release policies change in the future.
public Faezeh Kornokar
270, 5th East Danesh Alley, Molavi Street, Hashtsad Dastgah
Dorud Iran (Islamic Republic of) 6881755363 +98 66 4323 6285 Faezehkornokar@gmail.com Khoram-Abad University of Medical Sciences scientific Faezeh Kornokar
270, 5th East Danesh Alley, Molavi Street, Hashtsad Dastgah
Dorud Iran (Islamic Republic of) 6881755363 +98 66 4323 6285 Faezehkornokar@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Premature baby age 28 to 37 weeks, birth weight over 1000 grams, having a mother, The infant's vital signs are stable (oxygen saturation above 85%, respiratory rate between 30-60 breaths per minute, and heart rate between 120-160 breaths per minute) and ready for discharge from the hospital. Being a singleton, Living in Khorramabad, Minimum literacy of the mother (to answer the questionnaires), Mothers' willingness to participate in the study and perform kangaroo care at home and ability to use a telephone/mobile phone 1 day 28 days Both The presence of congenital abnormalities in the newborn, the presence of a history of advanced resuscitation, The infant's lack of identity, the presence of diagnosed mental disorders and addiction in the mother, the presence of self-reported serious tension with the spouse, The occurrence of an illness in the newborn that requires re-hospitalization, having wounds on the chest and abdomen of the mother and newborn, Stressful event during the study, such as loss or serious illness in a family member and the mother's unwillingness to continue participating in the study Treatment - Other Intervention group: After the infant’s condition stabilizes and they are transferred from the NICU to the neonatal ward, kangaroo care training for the mother will be provided face-to-face by the researcher using pamphlets and videos for the intervention group. To ensure correct maternal performance, practical kangaroo care will be demonstrated by the mother before discharge. The special kangaroo care clothing prepared by the researcher will also be given to the mothers in the intervention group prior to discharge. The intervention will continue at home with weekly virtual and phone follow-ups for four weeks after discharge. Mothers will perform kangaroo care for their infants at home twice daily, at scheduled times after feeding and diaper changes, wearing the special clothing, positioning themselves and the infant properly, and maintaining room temperature to prevent infant hypothermia. Each session will last 30 minutes and continue for four weeks Mother's resilience. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Connor and Davidson Resilience Questionnaire. Mother's parental competence. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Johnston and Mash Parental Competency Questionnaire. Maternal self-efficacy. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Barnes Parenting Self-Efficacy Questionnaire. Khoram-Abad University of Medical Sciences Approved 2025-07-14 Research Ethics Committee of Lorestan University of Medical Sciences 270, 5th East Danesh Alley, Molavi Street, Hashtsad Dastgah Khorram Abad Lorestan Iran (Islamic Republic of)