The Effects of the Mindfulness-Based Pregnancy Stress Reduction Program on Pregnant Women

NCT ID: NCT06924879

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Pregnant women participating in a mindfulness-based stress reduction program

The Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions will be applied to the pregnant women included in the intervention group and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery after the training.

Group Type: EXPERIMENTAL

Mindfulness-Based Pregnancy Stress Reduction Program

Intervention Type: OTHER

Mindfulness-Based Pregnancy Stress Reduction Program Training Content Session 1 Introduction to the program Course preparation Orientation process Session 2 Introduction to Mindfulness practices Session 3 Focusing on the moment Session 4 Coping with thoughts Connecting with pregnant women's bodies Becoming aware of their thoughts, feelings and bodily senses Session 5 Releasing emotions and thoughts Session 6 Awareness Session 7 Keeping distance from thoughts Session 8 Accepting Awareness

Pregnant women not participating in a mindfulness-based stress reduction program

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 after delivery with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-Based Pregnancy Stress Reduction Program

Mindfulness-Based Pregnancy Stress Reduction Program Training Content Session 1 Introduction to the program Course preparation Orientation process Session 2 Introduction to Mindfulness practices Session 3 Focusing on the moment Session 4 Coping with thoughts Connecting with pregnant women's bodies Becoming aware of their thoughts, feelings and bodily senses Session 5 Releasing emotions and thoughts Session 6 Awareness Session 7 Keeping distance from thoughts Session 8 Accepting Awareness

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Gülendan Güntürk

Master's degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay Akman, PhD lecturer

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Vezirkopru County State Hospital

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-363

Identifier Type: -

Identifier Source: org_study_id