Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06668467
Brief Summary:
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
Detailed Description:
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
The study is designed as a single-blind, randomised controlled trial. It will be conducted between November 2024 and January 2025 at the Zeynep Kamil Women and Children's Diseases Education and Research Hospital.
Power analysis using G\*Power showed that at least 35 samples would be sufficient for 2 groups with an effect size of 0.5, 95% power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).
Eligible women were randomised to the intervention group (n=35) and the control group (n=35). Women allocated to the intervention group received the MBSR programme. MBSR was scheduled for 4 weekly sessions of 30 minutes each. The control group received routine hospital care but no other intervention during this period.
The pre-test data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions and the measurement tools used in the study. After one week and at the end of 4 weeks, the same measurement tools were used to collect post-test data.
Participants were given information about the MBSR programme and told how, for how long, and where they would practise. The online MBSR programme was completed by the participants in a specific way for each session (with mind, body and breathing exercises). The MBSR programme was delivered in this way for 4 weeks (eight sessions in total, two sessions per week). In addition, participants were given homework (audio recordings) to repeat the mindfulness meditation practices throughout the week (until the next session). At the end of the fourth week, the measures were administered again to participants who had attended all eight sessions and completed their homework, and post-test data were collected.
Study:
NCT06668467
Study Brief:
Protocol Section:
NCT06668467