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

NCT06924879 | Completed

• 1 other identifier: 2024-363
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

pregnancy; stress; sleep quality; nursing; mindfulness

Outcome Measures

Primary Outcomes (3)

• Tilburg Distress Scale in Pregnancy

  The Tilburg Distress Scale in Pregnancy was developed to determine distress in pregnancy. The scale, which can be applied to pregnant women twelve weeks and over, consists of 16 items and is graded on a 4-point Likert scale (very often 0 points, quite often 1 point, occasionally 2 points, rarely/never 3 points). The total score that can be obtained from the scale varies between 0 and 48. According to the cut-off point, a total score of 28 and above indicates that the pregnant woman is at risk for distress. Items numbered 3, 5, 6, 7, 9, 10, 10, 11, 12, 13, 14, 16 in the scale are reverse coded. The scale has 2 sub-dimensions, "negative affect" consisting of 11 items and "partner involvement" consisting of 5 items. The items numbered 1, 2, 4, 8 and 15 in the scale belong to the "spousal involvement" sub-dimension, while the other items belong to the "negative affect" sub-dimension.

  From participation until the end of the 8th week

• Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index is a scale to assess sleep quality in psychiatry and clinical studies. The scale evaluates sleep disturbances and sleep quality in the last 1 month. The Turkish validity and reliability of the scale was performed by Agargün et al. Pittsburgh Sleep Quality Index consists of 24 questions and 7 sub-dimensions. These sub-dimensions are "subjective sleep quality", "sleep delay", "sleep duration", "habitual sleep efficiency", "sleep disturbance", "sleep medication use" and "daytime dysfunction". Each sub-dimension is evaluated with a score between 0-3 and the total scores of the sub-dimensions give the scale score. The total score of the scale is between 0-21. If the total score obtained from the scale is above 5, it is clinically evaluated as poor sleep quality (Agargün, 1996). Agargün et al. (1996) found the Cronbach's alpha reliability coefficient of the scale to be 0.804.

  From participation until 1 to 3 months postpartum

• Perceived Stress Scale

  The Perceived Stress Scale was developed to determine the extent to which individuals perceive certain situations in their lives as stressful. Its Turkish validity and reliability was conducted by Eskin et al. The Perceived Stress Scale consists of 10 items and measures how stressful people perceive some situations in their lives. The scale is a five-point Likert scale and is scored as 0 "never", 1 "almost never", 2 "sometimes", 3 "often", 4 "very often". The scores of the items containing 7 positive statements in the scale are reversed and the total score of the scale is obtained by adding the scores of the other items. Scores between 0-56 can be obtained from the scale. There is no cut-off point in the scale, and an increase in the score indicates that the stress perception of the individual is high. Eskin et al. (2013) found the Cronbach's alpha internal consistency coefficient of the scale to be 0.84.

  until the 1st to 3rd months after birth

Secondary Outcomes (1)

• Mindfulness Scale

  From participation until 1 to 3 months postpartum

Study Arms (2)

Pregnant women participating in a mindfulness-based stress reduction program

EXPERIMENTAL

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.

Other: Mindfulness-Based Pregnancy Stress Reduction Program

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

NO INTERVENTION

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.

Interventions

Mindfulness-Based Pregnancy Stress Reduction Program 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 participating in a mindfulness-based stress reduction program

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This study was administered to pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Vezirkopru County State Hospital

Samsun, 55000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Gülay Akman, PhD lecturer

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the study, in order to prevent selection bias, pregnant women randomly assigned to the intervention or control group by randomization method will not know which group they are in. However, since the researcher will know which group the pregnant women are in, one-way blinding will be performed during the data collection phase of the study. Since a statistical expert other than the researchers will perform the statistical analysis of the data obtained as a result of the research, two-way blinding will be performed at the statistical analysis stage.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)