Clinical trial NCT06924879: The Effects of the Mindfulness-Based Pregnancy Stress Reduction Program on Pregnant Women
Official title: The Effects of the Mindfulness -Based Pregnancy Stress Reduction Program on the Stress Levels, Sleep Quality and Awareness Levels of Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy
stress
sleep quality
nursing
mindfulness
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of two groups: experimental and control group. In the study, while the control group will receive routine pregnancy care, the experimental group will receive an 8-session mindfulness-based pregnancy stress reduction program.

Before randomization, pregnant women who meet the inclusion criteria will be informed about the study, their verbal and written consent will be obtained for participation in the study, and then pretest data will be collected. Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index and Mindfulness Scale will be used to collect pretest data from pregnant women who agree to participate in the study. After the pre-test data are collected, the pregnant women will be randomly assigned to one of the intervention and control groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women.

Hypotheses of the Study:

Hypothesis 1 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing stress levels of pregnant women.

Hypothesis 2 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving sleep quality of pregnant women.

Hypothesis 3 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing the mindfulness levels of pregnant women.

Hypothesis 4 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing women's stress levels in the postpartum period.

Hypothesis 5 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving women's sleep quality in the postpartum period.

Hypothesis 6 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing women's mindfulness levels in the postpartum period.

It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.

It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.

Detailed description: This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women. This study have been conducted between June 01, 2024 and December 31, 2024 in the obstetrics outpatient clinics of Vezirköprü State Hospital affiliated to Samsun Provincial Health Directorate. There are two obstetrics outpatient clinics, breastfeeding counseling/lactation-relactation outpatient clinic and a pregnancy school in the hospital where the research will be conducted. In addition to the outpatient clinics, there are pregnancy monitoring and nonstress testing rooms.

The population of the study will consist of pregnant women who applied to the Obstetrics and Gynecology Outpatient Clinics of Vezirköprü District State Hospital affiliated to Samsun Provincial Health Directorate. Pregnant women who applied to Vezirköprü District State Hospital Obstetrics and Gynecology Outpatient Clinics and met the criteria for inclusion in the sample will be included in the sample of the study.

In order to determine a significant group effect in the sample calculation of the study, the minimum sample size was calculated as 33 pregnant women in the intervention group, 33 pregnant women in the control group, and 66 pregnant women in total, using an alpha margin of error of 0.05, a research power of 0.80 and an intermediate group effect (partial eta squared) of 0.03. In order to strengthen the results of the study and increase reliability and against the possibility of sample loss during the study, it was decided to include 80 pregnant women (40 intervention and 40 control), which is 20% more than the sample size.

It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.

It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.

Eligibility criteria: Inclusion Criteria:

* - Volunteering to participate in the research,
* Be over 18 years of age,
* Being literate,
* To be able to understand and speak Turkish,
* Nulliparous conception,
* Don't be a singleton,
* Gestational age between 24-32 weeks.

Exclusion Criteria:

* - Multiparous pregnancy,
* Don't have a high-risk pregnancy,
* Do not have a diagnosed psychiatric illness,
* Conception as a result of infertility treatment,
* Attending childbirth preparation courses
* Planning a cesarean birth
* Previous experience of yoga and meditation,
* Don't want to leave the research,
* Not attending any session of the Mindfulness-Based Pregnancy Stress Reduction Program
* Failure to complete the data collection tools completely.

Primary outcomes:
measure: Tilburg Distress Scale in Pregnancy
timeFrame: From participation until the end of the 8th week
measure: Pittsburgh Sleep Quality Index
timeFrame: From participation until 1 to 3 months postpartum
measure: Perceived Stress Scale
timeFrame: until the 1st to 3rd months after birth
Secondary outcomes:
measure: Mindfulness Scale
timeFrame: From participation until 1 to 3 months postpartum
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Vezirkopru County State Hospital
Study officials:
affiliation: Ondokuz Mayıs University
name: Gülay Akman, PhD lecturer
role: STUDY_DIRECTOR
References: