- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07660393
Virtual Reality Glass Use
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women With Premature Rupture of Membranes: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Seyhan Çankaya
- Telefonnummer: 05054300733
- E-mail: seyhane32@gmail.com
Studiesteder
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Konya, Tyrkiet (Türkiye), 42250
- Rekruttering
- Seyhan Çankaya
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Kontakt:
- Seyhan Çankaya
- Telefonnummer: 05054300733
- E-mail: seyhane32@gmail.com
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Ledende efterforsker:
- Seyhan Çankaya, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Being 18 years of age or older
- Being nulliparous
- Having a diagnosis of preterm premature rupture of membranes (PPROM)
- Being between 24 and 37 weeks of gestation
- Having a singleton pregnancy
- Being hospitalized in the ward for at least 3 days
- Having no visual or hearing impairment
- Being communicative and mentally and psychologically healthy
- Being able to speak and express oneself in Turkish
Exclusion Criteria:
- Having an additional diagnosis besides preterm premature rupture of membranes (PPROM) (e.g., preeclampsia, fetal distress, fetal anomalies, gestational diabetes, bleeding, etc.)
- Having a chronic disease (e.g., hypertension, diabetes mellitus, thyroid disorders, etc.)
- Having conceived through assisted reproductive technologies (ART)
- Having any skin infection.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Standard prenatal care
The control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish. |
The control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish.
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
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Eksperimentel: Nature-themed video
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
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Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.
Tidsramme: 6 months
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Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.
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6 months
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Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.
Tidsramme: 6 months
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The Fetal Health Concern Scale will be administered to pregnant women. The Fetal Health Concern Scale ranges from 0 to 42 points (minimum-maximum), with higher scores indicating greater fetal health concern. |
6 months
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Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
Tidsramme: 6 months
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The Prenatal Distress Scale will be administered to all pregnant women. The Prenatal Distress Scale ranges from 0 to 34 points (minimum-maximum), with higher scores indicating greater prenatal distress. |
6 months
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Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.
Tidsramme: 6 months
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The Prenatal Attachment Inventory will be administered to all pregnant women. The Prenatal Attachment Inventory score ranges from 21 to 84 points (minimum-maximum), with higher scores indicating greater prenatal distress. |
6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025/1150
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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