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L'effet d'un programme de réduction du stress basé sur la pleine conscience sur l'adaptation à la grossesse, le stress et les niveaux d'anxiété fœtale chez les femmes ayant conçu après un traitement contre l'infertilité (MBSR-PAFS)

18 septembre 2026 mis à jour par: Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University

EFFET D'UN PROGRAMME DE RÉDUCTION DU STRESS BASÉ SUR LA PLEINE CONSCIENCE SUR L'ADAPTATION À LA GROSSESSE, LE STRESS ET LES NIVEAUX D'ANXIÉTÉ FŒTALE CHEZ LES FEMMES AYANT CONÇU APRÈS UN TRAITEMENT CONTRE L'INFERTILITÉ : UN ESSAI CONTRÔLÉ RANDOMISÉ

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.

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Aperçu de l'étude

Description détaillée

Infertility treatment is a physically and emotionally demanding process. Although achieving pregnancy after infertility treatment is often perceived as a positive outcome, many women continue to experience significant psychological challenges during pregnancy, including heightened stress, difficulty adapting to pregnancy, and persistent anxiety regarding fetal health. These emotional responses may negatively affect maternal well-being, pregnancy adaptation, and pregnancy outcomes. Despite the growing body of evidence supporting mindfulness-based interventions during pregnancy, there is limited research focusing specifically on women who conceive following infertility treatment.

Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based program that aims to enhance awareness of present-moment experiences through mindfulness practices such as meditation, breathing exercises, body awareness, gentle yoga, and self-compassion practices. Previous studies have demonstrated that MBSR can effectively reduce stress and anxiety and improve psychological well-being in various populations, including pregnant women and women undergoing infertility treatment. However, the effects of MBSR on pregnancy adaptation and fetal health anxiety among women who become pregnant after infertility treatment have not been adequately investigated.

This randomized controlled study is designed to evaluate the effectiveness of an MBSR program on pregnancy adaptation, perceived stress, and fetal health anxiety in women who conceived following infertility treatment. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive an MBSR program delivered over four weeks, consisting of structured sessions that include mindfulness meditation, breathing-focused practices, body scan exercises, gentle yoga, emotional awareness, self-compassion training, and practices aimed at strengthening maternal-fetal bonding. Participants will also be encouraged to engage in daily mindfulness practices at home.

The control group will receive routine prenatal care and will not participate in any structured psychological or mindfulness-based intervention during the study period. After completion of post-intervention assessments, participants in the control group who wish to receive the MBSR training will be offered the program.

Data will be collected at baseline (pre-test) and after completion of the intervention (post-test) using validated instruments to assess pregnancy-related distress, pregnancy adaptation, and fetal health anxiety. The primary outcomes of the study are changes in perceived stress levels, pregnancy adaptation, and fetal health anxiety scores between the intervention and control groups.

The findings of this study are expected to provide evidence on the potential benefits of MBSR as a supportive, non-pharmacological intervention for improving psychological well-being and pregnancy adaptation in women who conceive following infertility treatment. The results may contribute to the development of holistic, evidence-based prenatal care approaches and inform healthcare professionals about effective strategies to support this vulnerable population.

Type d'étude

Interventionnel

Inscription (Réel)

76

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • K.maraş
      • Kahramanmaraş, K.maraş, Turquie (Türkiye), 46100
        • Kahramanmaraş Sütçü İmama Universty

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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

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

Aucune intervention: control group

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Tilburg Distress in Pregnancy Scale
Délai: 1 month

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)
Délai: 1 month

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

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1 month
Fetal Anxiety Scale (FAS)
Délai: 1 month

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 janvier 2026

Achèvement primaire (Réel)

28 février 2026

Achèvement de l'étude (Réel)

30 mai 2026

Dates d'inscription aux études

Première soumission

13 décembre 2025

Première soumission répondant aux critères de contrôle qualité

13 décembre 2025

Première publication (Réel)

29 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 septembre 2026

Dernière vérification

1 décembre 2025

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KahramanmaraşSIUI9

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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