Clinical trial NCT06668467: The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply
Official title: The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding self-efficacy
Mindfulness
Insufficient milk
Social support
Stress
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-35
* 37 weeks or more of gestation
* Primipar
* Having given birth vaginally
* University Health Application and Research Center, Gynaecology and Obstetrics Clinic
* Having a single and healthy baby (no multiple pregnancy)
* Having completed at least primary school
* Being able to communicate in Turkish by phone using the WhatsApp application
* The baby is with the mother

Exclusion Criteria:

* Having a high-risk pregnancy
* Having a medical condition or taking medication that prevents breastfeeding
* Having a communication problems (vision, hearing, speech, language problems)
* Having a psychiatric illness
* There is an obstacle that prevents the baby from being with the mother or being in the neonatal intensive care unit
* Having a condition/disease that prevents you from doing mindfulness practices (breathing exercises, body scanning)

Primary outcomes:
measure: Mindful Breastfeeding Scale (MIND-BFS)
timeFrame: Day 1, Day 7, Day 30 after delivery
measure: Breastfeeding Self-Efficacy Scale
timeFrame: Day 1, Day 7, Day 30 after delivery
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: Day 1, Day 7, Day 30 after delivery
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Day 1, Day 7, Day 30 after delivery
measure: Insufficient Milk Perception Scale
timeFrame: Day 1, Day 7, Day 30 after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Leyla Kaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: