- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07724249
The Effect of a Virtual Reality Video Intervention
The Effect of a Virtual Reality Headset-Based Video Intervention on Fear of Childbirth and Anxiety in High-Risk Pregnant Women
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Pregnancy is a physiological process; however, approximately one-third of pregnancies are classified as high-risk due to maternal, fetal, or obstetric conditions that may threaten the health of the mother and/or fetus. Women with high-risk pregnancies frequently require hospitalization and bed rest for close maternal and fetal monitoring. Although hospitalization is essential for preventing adverse pregnancy outcomes, prolonged bed rest and uncertainty regarding pregnancy outcomes may increase psychological distress, particularly fear of childbirth and anxiety.
Fear of childbirth and anxiety are common among women with high-risk pregnancies and may negatively affect maternal well-being, treatment adherence, and pregnancy outcomes. Therefore, effective, safe, and non-pharmacological interventions that reduce psychological distress during hospitalization are needed.
Virtual reality (VR) is an immersive technology that provides users with a three-dimensional virtual environment and has been increasingly used as a distraction and relaxation intervention in healthcare settings. Previous studies have demonstrated that VR may reduce pain, anxiety, and stress in various clinical populations by diverting attention from unpleasant stimuli and promoting relaxation. However, evidence regarding the effectiveness of VR in reducing fear of childbirth and anxiety among hospitalized women with high-risk pregnancies is limited.
The present study is designed as a randomized controlled trial to evaluate the effectiveness of a VR-based relaxation intervention in hospitalized high-risk pregnant women receiving bed rest. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using block randomization.
Participants in the intervention group will receive routine obstetric and nursing care in addition to a VR intervention. During the intervention, participants will wear a compatible VR headset and watch a 360-degree nature-themed relaxation video accompanied by calming natural sounds for approximately 15 minutes while resting in bed. Participants in the control group will receive routine obstetric and nursing care only.
The primary outcomes of the study are fear of childbirth and anxiety. These outcomes will be measured using validated assessment instruments before and after the intervention. The effectiveness of the VR intervention will be determined by comparing outcome measures between the intervention and control groups.
This study is expected to provide evidence regarding the effectiveness of virtual reality as a safe, inexpensive, and non-pharmacological nursing intervention for reducing fear of childbirth and anxiety among hospitalized high-risk pregnant women. If effective, VR may be incorporated into routine prenatal inpatient care to improve maternal psychological well-being.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sümeyye Bal, Ph.D.
- Numero di telefono: 6424 0(362)3121919
- Email: sumeyyebal@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Women aged 18 years or older
- Willing to participate in the study and provide written informed consent
- No diagnosed psychiatric or mental disorder
Exclusion Criteria:
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Virtual Reality Group
In addition to routine obstetric and nursing care, participants assigned to the virtual reality group will receive a virtual reality intervention.
Women in this group will wear a virtual reality headset while resting in bed and watch a relaxing 360° nature video accompanied by calming natural sounds for approximately 30 minutes.
The virtual reality intervention is designed to promote relaxation and reduce fear of childbirth and anxiety during hospitalization.
|
Participants assigned to the control group will receive routine obstetric and nursing care only.
No additional intervention will be administered.
Altri nomi:
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Nessun intervento: control group
Participants assigned to the control group will receive routine obstetric and nursing care only.
No additional intervention will be administered.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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State Anxiety
Lasso di tempo: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
State Anxiety Inventory (SAI) (State subscale of the State-Trait Anxiety Inventory, STAI-State)
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Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
|
Fear of Childbirth
Lasso di tempo: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)
|
Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2023/44
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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