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IRCT20200913048704N6 IRCT 2026-10-25 Babol University of Medical Sciences The Effect of Mindfulness Exercises on Breastfeeding Self-Efficacy in Mothers of Premature Infants Hospitalized in the Neonatal Intensive Care Unit MW-BSE Investigating the Effect of a Mindfulness Intervention on Breastfeeding Self-Efficacy in Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit: A randomized trial study 2026-10-23 anticipated 64 Recruiting https://irct.ir/trial/93318 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Mothers of infants hospitalized in the NICU at Besat Hospital in Sanandaj will be selected via a convenience sampling method and subsequently randomly assigned to either an intervention group or a control group. Given that study participants do not enter the study simultaneously and group assignment for each incoming participant is unpredictable, block randomization (using blocks of eight) will be employed to allocate the target mothers to one of the two study groups (Group A or Group B). Mothers will be assigned to one of two groups at a 1:1 ratio using a block randomization protocol (generated by Random Allocation Software), ensuring that the researcher cannot predict the group assignment of the next participant. Participant allocation to the intervention and control groups will be based on the output of randomization software (Random Sequence Generator). The randomization list will be prepared prior to the start of recruitment and kept in sealed, opaque envelopes. Upon the enrollment of each participant and the verification of eligibility criteria, the researcher will open the corresponding envelope in sequence, and the individual will be assigned to one of the two groups based on the number inside. To ensure allocation concealment, the personnel responsible for recruitment will remain unaware of the randomization list's contents, Blinding description: Given the study design, participating mothers will be aware of the intervention group assignments; therefore, blinding will not be feasible during the initial phase. However, the data will be provided to the statistician for analysis in a blinded manner, using group randomization codes. N/A -. Intervention 1: Intervention group: In addition to routine care, mothers in the intervention group receive eight mindfulness practice sessions delivered in person on an individual basis. The researcher will conduct these mindfulness sessions at the hospital, holding one 90-minute session per week. Alongside the in-person instruction, audio files corresponding to each session will be provided to the mothers at the end of the session. Intervention 2: Control group: Mothers in the control group will receive only routine ward care. Yes - There is a plan to make this available What will be shared: Data on primary and secondary outcomes When: 6 months after the publication of the results To whom: All interested people Conditions: The use of the results of this study is allowed in compliance with ethical principles. Where to obtain: Via the corresponding author's email (Ali Zabihi) zabihi_alii@yahoo.com How to obtain: Applicants will receive the results via email after one week. Comments:
public Ali Zabihi
Babol University of Medical Sciences, Ganj-Afrouz Street, Kargar Square, Babol, Iran.
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 0597 zabihi_alii@yahoo.com Babol University of Medical Sciences scientific Ali Zabihi
Babol University of Medical Sciences, Ganj-Afrouz Street, Kargar Square, Babol, Iran.
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 0597 zabihi_alii@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) The mother's willingness to participate in the study and provide informed consent A mother with a preterm infant—born at a gestational age of 32 to 37 weeks—admitted to the Neonatal Intensive Care Unit (NICU) Mothers of premature infants who are able to breastfeed directly from the breast Ability to read and write in Persian Availability of the mother Ability to participate in the educational sessions in case of discharge from the hospital No previous history of mindfulness training No chronic underlying disease or congenital anomaly in the infant No history of maternal use of sedative or psychotropic medications before or during pregnancy No history of depression or anxiety Maternal age between 18 and 45 years Low breastfeeding self-efficacy score at pre-test 18 years 45 years Female Death of the infant The infant requires treatment in such a way that continuation of breastfeeding directly from the breast is not possible The simultaneous presence of mothers from both the control and intervention groups in the ward, in a scenario where the time to infant discharge is longer for mothers in the control group than for those in the intervention group. - - Other Other Intervention group: In addition to routine care, mothers in the intervention group receive eight mindfulness practice sessions delivered in person on an individual basis. The researcher will conduct these mindfulness sessions at the hospital, holding one 90-minute session per week. Alongside the in-person instruction, audio files corresponding to each session will be provided to the mothers at the end of the session. Control group: Mothers in the control group will receive only routine ward care. Maternal Breastfeeding Self-Efficacy. Timepoint: Before the intervention, after the intervention, concurrently with the final mindfulness practice session, and one month after the last mindfulness practice session. Method of measurement: Questionnaire. Maternal stress, Exclusive Breastfeeding. Timepoint: Before the intervention, after the intervention, concurrently with the final mindfulness practice session, and one month after the last mindfulness practice session. Method of measurement: Questionnaire. Babol University of Medical Sciences Approved 2026-08-31 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj-Afrouz Street, Kargar Square, Babol, Iran. Babol Mazandaran Iran (Islamic Republic of)