- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07704541
Effect of Mandala Art Therapy on Childbirth Fear and Anxiety in Expectant Fathers
17. juli 2026 opdateret af: Melike TAN ÇELİK, Inonu University
The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study
This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor.
Eligible participants will be randomly allocated to either the intervention or the control group.
Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention.
Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention.
The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a randomized controlled trial designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among expectant fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor.
Eligible participants will be randomly allocated to either the intervention or the control group using a simple randomization procedure.
Participants assigned to the intervention group will receive a single, individually administered mandala art therapy session lasting approximately 20-25 minutes.
During the session, participants will be encouraged to select their preferred mandala patterns and colors, thereby facilitating individual expression and engagement in the therapeutic process.
Participants in the control group will receive routine care without any additional intervention and will undergo the same assessment procedures as the intervention group.
Data will be collected at two time points: immediately before the intervention (baseline) and immediately after the intervention.
The primary outcome of the study is childbirth fear, while the secondary outcome is state anxiety.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
148
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: ESRA GÜNEY, Associate Professor
- Telefonnummer: +90 5432064063
- E-mail: esra.guney@inonu.edu.tr
Undersøgelse Kontakt Backup
- Navn: Melike Tan, midwife
- Telefonnummer: +90 5452259635
- E-mail: melike9635@gmail.com
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
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study
Exclusion Criteria:
- Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period
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 |
|---|---|
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Eksperimentel: Mandala Art Therapy Group
Participants in this group will receive mandala art therapy.
The intervention consists of a 20-25 minute individual mandala coloring activity conducted in the obstetric waiting area.
Participants will be provided with a mandala coloring book and colored pencils and will freely choose patterns and colors.
|
Participants will engage in a mandala coloring activity lasting approximately 20-25 minutes.
The intervention is designed as a relaxation-based expressive art therapy.
Participants will select mandala patterns and colors freely.
No guidance or psychological counseling is provided during the activity.
|
|
Ingen indgriben: Control Group
Participants in this group will receive no intervention.
They will complete the same pre-test and post-test assessments as the intervention group at the same time points.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Childbirth Fear
Tidsramme: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
|
Childbirth fear will be assessed using the Fathers' Birth Fear Scale (BDKÖ).
The scale measures fathers' fear related to childbirth process and hospital-related concerns.
Higher scores indicate higher levels of childbirth fear.
Assessments will be performed before and after the mandala art therapy intervention.
|
Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Melike Tan, midwife, İnönü University Faculty of Health Sciences
- Studieleder: Esra GÜNEY, Associate Professor, İnönü University Faculty of Health Sciences
- Ledende efterforsker: Zeynep Bal, PhD, Turgut Özal University Faculty of Health Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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 (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. oktober 2026
Studieafslutning (Anslået)
1. november 2026
Datoer for studieregistrering
Først indsendt
13. juni 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10843
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No, individual participant data will not be shared.
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