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Study aim:
Determining the Effectiveness of Mindfulness on Breastfeeding Self-Efficacy in Mothers of Preterm Infants Hospitalized in the NICU
Design:
This study is a randomized, single-blind, controlled, Phase 3 clinical trial involving 64 mothers of preterm infants. Mothers will be assigned to either the intervention group or the control group in a 1:1 ratio using a block randomization method with blocks of eight (generated by Random Allocation Software).
Settings and conduct:
This clinical trial will be conducted at Besat Hospital in Sanandaj. Given the nature of the study, participating mothers will be aware of the intervention; therefore, blinding will be implemented only for the data analyst.
Participants/Inclusion and exclusion criteria:
1- Mothers of hospitalized preterm infants with a gestational age of 32 to 37 weeks
2- Ability to attend educational sessions in the event of discharge
3- No history of mindfulness training
4- No history of using sedatives or psychotropic medications prior to or during pregnancy
5- No history of depression or anxiety disorders
6- Maternal age range (18 to 45 years)
7- Low breastfeeding self-efficacy score on the pre-test
Intervention groups:
In addition to routine care, mothers in the intervention group will receive eight mindfulness training sessions delivered in person on an individual basis. After obtaining the relevant training certification, the researcher will conduct these sessions—each lasting 90 minutes and held weekly at the hospital—face-to-face with each mother in the intervention group. Additionally, at the end of each session, the mothers will be provided with audio files containing the mindfulness exercises covered in that session. Mothers in the control group will receive the ward's routine care.
Main outcome variables:
Mothers' breastfeeding self-efficacy