The Effect of a Mindfulness-Based Stress Reduction Program on Pregnancy Adaptation, Stress, and Fetal Anxiety Levels in Women Who Conceived After Infertility Treatment

NCT07307196 | Not Yet Recruiting DMC

• 1 other identifier: KahramanmaraşSIUI9
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Infertility treatment is a long and challenging process. Women who become pregnant after this process may experience stress, anxiety and intense concerns about the baby's health alongside their happiness. These feelings can negatively affect the mother's adjustment to pregnancy and her psychological well-being. This study was designed to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) programme, administered to women who became pregnant after infertility treatment, on: stress levels during pregnancy, adaptation to pregnancy, and foetal (baby's health-related) anxiety. Pregnant women participating in the study will be divided into two groups: an experimental group and a control group. Women in the experimental group will receive mindfulness-based stress reduction training lasting approximately 4 weeks. This programme includes breathing exercises, meditation, body awareness, self-compassion exercises, and practices aimed at strengthening the mother-baby bond. The control group will not receive any training during this period. Translated with DeepL.com (free version)

Conditions

Pre - Delivery Pregnant Women; Infertile Females or Females With Ovarian Insufficiency

Keywords

infertility; pregnancy; stress; midwifery

Outcome Measures

Primary Outcomes (3)

• Tilburg Distress in Pregnancy Scale

  Description: It was developed by Pop et al. in the Netherlands in 2011 for the diagnosis of distress in pregnancy. It was translated into Turkish by Çapık in 2013 after a Turkish validity and reliability study. The scale consists of a total of 16 items. It is 4-point Likert type. The lowest score that can be obtained from the total scale is 0 and the highest score is 48. The scale has two sub-dimensions as 'Negative affect' and 'Partner involvement'. The scale can be applied to pregnant women aged 12 weeks and above. Cronbach's alpha coefficient of the original scale was 0.78. The Cronbach's alpha coefficient of the Turkish form of the scale is 0.80 (Çapık et al. 2015).

  1 month

• Prenatal Self-Assessment Scale (PSAS)

  Developed by Lederman in 1979 to assess adaptation to motherhood (Lederman 1979), the validity and reliability of this scale in Turkish were established in 2006 by Beydağ and Mete in 21 health centres in the province of Denizli. This four-point Likert-type scale consists of 79 items. The scale has seven subscales: thoughts about one's own and the baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship with one's own mother, and relationship with one's spouse. Each subscale contains between 10 and 15 items (Beydağ and Mete 2008). Forty-seven of the items in this scale are reverse-scored (1, 2, 3, 4, 6, 7, 8, 10, 11, 12, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 31, 32, 33, 35, 37, 38, 40, 47, 48, 49, 50, 53, 55, 56, 59, 60, 61, 70, 71, 72, 73, 74, 75, 78, 79) (Beydağ and Mete 2008). Each item on the scale Translated with DeepL.com (free version)

  1 month

• Fetal Anxiety Scale (FAS)

  The scale, developed by Reiser and Wright (2019), measures pregnant women's anxiety about the health of their foetus. The FAS has no subscales and consists of 14 items. Each item consists of 4 statements that best reflect the experiences of pregnant women in the past weeks. Items on the scale are scored from 0 (no symptoms) to 3 (severe symptoms), and the sum of the items yields the total foetal health anxiety score (0-42), with higher scores indicating increased levels of foetal health anxiety. The scale's Cronbach's alpha value is 0.85 (Gökbulut et al., 2024).

  1 month

Study Arms (2)

Experimental

EXPERIMENTAL

MBSRParticipants allocated to the experimental arm will receive a structured Mindfulness-Based Stress Reduction (MBSR) program in addition to routine prenatal care. The MBSR intervention is delivered in a group format by a trained researcher and is adapted for pregnant women who conceived following infertility treatment. The program is conducted over 4 weeks, with two sessions per week. Each session includes guided mindfulness practices such as breathing-focused meditation, body scan exercises, gentle pregnancy-safe yoga movements, emotional awareness practices, and self-compassion exercises. The intervention also includes mindfulness practices aimed at strengthening maternal-fetal bonding, such as loving-kindness meditation directed toward the fetus and mindful awareness of bodily sensations related to pregnancy. Participants are encouraged to engage in daily home practice using provided audio-guided materials. The primary purpose of this arm is to reduce pregnancy-related stress a

Behavioral: MBSR

control group

NO INTERVENTION

Participants allocated to the control arm will receive routine prenatal care only and will not participate in any structured mindfulness or psychological intervention during the study period. After completion of post-intervention assessments, participants in the control arm will be offered the MBSR program upon request.

Interventions

MBSR BEHAVIORAL

Participants allocated to the experimental arm will receive a structured Mindfulness-Based Stress Reduction (MBSR) program in addition to routine prenatal care. The MBSR intervention is delivered in a group format by a trained researcher and is adapted for pregnant women who conceived following infertility treatment. The program is conducted over 4 weeks, with two sessions per week. Each session includes guided mindfulness practices such as breathing-focused meditation, body scan exercises, gentle pregnancy-safe yoga movements, emotional awareness practices, and self-compassion exercises. The intervention also includes mindfulness practices aimed at strengthening maternal-fetal bonding, such as loving-kindness meditation directed toward the fetus and mindful awareness of bodily sensations related to pregnancy. Participants are encouraged to engage in daily home practice using provided audio-guided materials. The primary purpose of this arm is to reduce pregnancy-related stress and fe

Experimental

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• As a result of infertility treatment,
• Pregnancy week 10-28. Pregnant women in their 10th to 28th week of pregnancy
• with no foetal abnormalities,
• without any psychiatric diagnosis,
• able to communicate and willing to participate in the study

You may not qualify if:

• Pregnant women who participated in mind-body practices or any prenatal class/programme during the study period.
• Those with communication difficulties

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş, K.maraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

HATİCE GÜL ÖZTAŞ, DİRECTOR

CONTACT

+905428267629; h.gul_akbaba@hotmail.com.tr

HATİCE GÜL ÖZTAŞ

CONTACT

05428267629; haticeguloztas@ksu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: January 10, 2026
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)