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

The Effects of the Mindfulness -Based Pregnancy Stress Reduction Program on the Stress Levels, Sleep Quality and Awareness Levels of Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Mindfulness-Based Pregnancy Stress Reduction Program

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55000
    • Vezirkopru County State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness Scale	The Mindfulness Scale (MBAS), developed to measures individual differences in attention and awareness skills towards momentary experiences (Brown & Ryan, 2003).The Mindfulness Scale aims to determine whether there is awareness and attention in relation to what is happening in the present rather than elements related to mindfulness such as acceptance, trust, and co-sensation. It is used to assess individual differences in the frequency of mindfulness. It consists of 15 items, each with declarative and affirmative statements. The Mindfulness Scale measures how often individuals experience a particular situation using a 6-point Likert scale. Scores are between 1 and 6. The lowest score that can be obtained from the scale is 15 and the highest score is 90. A high score on the scale means that the level of mindfulness is high. Özyeşil et al. (2013) calculated the internal consistency coefficient of the scale as 0.82 and the test-retest correlation as 0.86.	From participation until 1 to 3 months postpartum

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Director: Gülay Akman, PhD lecturer, Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; mindfulness; stress; nursing; sleep quality
• Other Study ID Numbers: 2024-363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No