Mindfulness-pohjaisen stressinhallintaohjelman vaikutus raskauden sopeutumiseen, stressiin ja sikiön ahdistustasoihin naisilla, jotka ovat tuleet raskaaksi hedelmöityshoidon jälkeen (MBSR-PAFS)
MINDFULNESS-POHJAISEN STRESSINVÄHENTÄMISOHJELMAN VAIKUTUS RASKAUDSOPEUTUMISEEN, STRESSIIN JA SIKIÖN AHISTUNEISUUSTASOIHIN NAISILLA, JOILLA ON ONNISTUNUT HEDELMÖITYSHOITOJEN JÄLKEEN: SATUNNAISTETTU KONTROLLOITU TUTKIMUS
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)
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
K.maraş
-
Kahramanmaraş, K.maraş, Turkki (Türkiye), 46100
- Kahramanmaraş Sütçü İmama Universty
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
|
Ei väliintuloa: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Tilburg Distress in Pregnancy Scale
Aikaikkuna: 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)
Aikaikkuna: 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 Translated with DeepL.com (free version) |
1 month
|
|
Fetal Anxiety Scale (FAS)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- KahramanmaraşSIUI9
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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