- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07663812
THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES (ALEXITHYMIA)
23. juni 2026 opdateret af: ESMA KIR, Tokat Gaziosmanpasa University
THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED BY MIDWIVES DURING PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES
The aim of this study is to examine the effect of midwife-led motivational interviewing during pregnancy on couples' stress and alexithymia levels.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
This study aims to evaluate the effect of midwife-led motivational interviewing during pregnancy on couples' stress coping skills and levels of alexithymia.
Designed as a randomized controlled trial, the study includes healthy pregnant women in their second trimester and their partners.
The intervention group receives midwife-led motivational interviewing, while the control group receives routine care.
Data are collected using the Demographic Information Form, the Coping Styles Scale, and the Toronto Alexithymia Scale.
The study results will determine whether midwife-led motivational interviews are an effective intervention for supporting psychological well-being during pregnancy through a couple-centered approach.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: ESMA KIR
- Telefonnummer: +905550617545
- E-mail: esma.kir@bozok.edu.tr
Studiesteder
-
-
Center
-
Yozgat, Center, Tyrkiet (Türkiye)
- Rekruttering
- Yozgat City Hospital
-
Kontakt:
- ESMA KIR
- Telefonnummer: 05550617545
- E-mail: esma.kir@bozok.edu.tr.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
For pregnant women:
- Agreement to participate in the study
- Being 18 years of age or older and married
- Being in the second trimester
- No pregnancy-related risks (such as preeclampsia, diabetes, heart disease, placenta previa, or oligohydramnios),
- No issues related to fetal health (such as fetal anomalies or intrauterine growth restriction),
- Ability to speak Turkish,
- No history of chronic or psychiatric conditions,
For partners:
- Agreeing to participate in the study,
- Accompanying their partner during the second trimester of pregnancy,
- Not having a diagnosed psychiatric condition (depression, anxiety disorder, bipolar disorder, etc.),
- Being able to speak and understand Turkish,
Exclusion Criteria:
• Participants deciding to withdraw from the study at any stage,
- Inability to contact the pregnant woman and/or her partner before the data collection process is completed,
- The pregnant woman being diagnosed with a high-risk pregnancy during the data collection process.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: No motivational interview
the group of pregnant women and their partners who did not receive motivational counseling
|
|
|
Eksperimentel: There is a motivational interview
a group where motivational sessions are held for pregnant women and their partners
|
a group where motivational sessions are held for pregnant women and their partners
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1. Stress Coping Styles Scale (SCSS):
Tidsramme: 24 weeks
|
Couples' stress coping skills are being assessed.
The assessment is administered twice: as a pre-test (at the beginning) and a post-test (after the intervention).
Both the total scale score and the subscale scores are used.
|
24 weeks
|
|
1. Stress Coping Styles Scale (SCSS): This scale assesses couples' stress coping skills. It is administered twice: at the pre-test (baseline) and post-test (post-intervention). Both the total scale score and the subscale scores are used.
Tidsramme: 24 weeks
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
2. Toronto Alexithymia Scale (TAS):
Tidsramme: 24 weeks
|
Couples' levels of alexithymia are being assessed.
The assessment is administered twice: as a pre-test (at the beginning) and a post-test (after the intervention).
Both the total scale score and the subscale scores are used.
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. januar 2026
Primær færdiggørelse (Anslået)
30. oktober 2026
Studieafslutning (Anslået)
30. oktober 2026
Datoer for studieregistrering
Først indsendt
13. juni 2026
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
23. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 30.10.2025 - 646244
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
To protect the privacy of participants' personal data and comply with the requirements of the ethics committee's approval, individual patient data will not be shared.
The study involves a sensitive population-pregnant women and their partners-and the data collected will be used solely for the purposes of this research.
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