- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07745959
Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction
Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction: A Randomized Controlled Trial
Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction.
Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients scheduled to undergo upper gastrointestinal endoscopy will be enrolled and randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group. Participants in the intervention group will receive a virtual reality application before the endoscopy procedure, whereas participants in the control group will receive standard care. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, and patient satisfaction will be assessed immediately after the procedure.
Expected Results: It is anticipated that the virtual reality intervention will reduce preprocedural anxiety, improve psychological readiness, and increase postprocedural satisfaction compared with standard care.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Upper gastrointestinal endoscopy is one of the most frequently performed diagnostic procedures for evaluating disorders of the upper gastrointestinal tract. Although it is generally considered safe, many patients experience considerable anxiety before the procedure. High levels of preprocedural anxiety may negatively affect psychological readiness, reduce patient cooperation, impair the overall procedural experience, and decrease satisfaction with care. Therefore, effective non-pharmacological interventions that improve the patient's psychological state before endoscopy are needed.
Virtual reality (VR) is an immersive technology that provides visual and auditory stimulation, allowing individuals to become engaged in a relaxing virtual environment and divert their attention from stressful situations. Previous studies have demonstrated that virtual reality can reduce anxiety, pain, and physiological stress during various medical procedures. However, evidence regarding the effectiveness of virtual reality when applied before upper gastrointestinal endoscopy, particularly its effects on psychological readiness and postprocedural satisfaction, remains limited.
This randomized controlled trial aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. The study will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group using block randomization.
Participants in the intervention group will receive a virtual reality application before the endoscopy procedure in addition to standard care. Participants in the control group will receive standard preprocedural care only. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, while postprocedural satisfaction will be assessed immediately after completion of the endoscopy.
The findings of this study are expected to provide evidence regarding the effectiveness of virtual reality as a simple, non-invasive, and low-cost intervention for reducing preprocedural anxiety, improving patients' psychological readiness for upper gastrointestinal endoscopy, and enhancing satisfaction with the procedure. The results may contribute to the development of evidence-based nursing interventions and improve patient-centered care in endoscopy units.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: DERYA ŞİMŞEKLİ, PhD
- Telefonnummer: +905545965789
- E-post: deryasimsekli@ardahan.edu.tr
Studiesteder
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Erzurum, Tyrkia (Türkiye), 25400
- Ataturk University Research Hospital
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Ta kontakt med:
- DERYA ŞİMŞEKLİ, PhD
- Telefonnummer: 05545965789
- E-post: deryasimsekli@ardahan.edu.tr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Aged 18 years or older
- Scheduled to undergo upper gastrointestinal endoscopy
- Able to understand and communicate in Turkish
- Willing to participate in the study
- Providing written informed consent
Exclusion Criteria:
- Presence of a diagnosed psychiatric or neurological disorder that may interfere with participation
- Presence of a visual, hearing, head, face, or eye condition that prevents the use of a virtual reality headset
- History of severe vertigo, motion sickness, or balance disorder
- Development of severe dizziness, nausea, eye strain, or discomfort during the virtual reality intervention
- Refusal to participate or withdrawal from the study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Experimental
Participants will receive a virtual reality intervention before upper gastrointestinal endoscopy in addition to standard preprocedural care.
The virtual reality application will be administered before the endoscopy procedure using a virtual reality headset.
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Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.
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Aktiv komparator: Standard Care Group
Participants will receive a virtual reality intervention using a virtual reality headset before upper gastrointestinal endoscopy.
The intervention is designed to reduce preprocedural anxiety, improve psychological readiness, and enhance patient satisfaction.
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Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Preprocedural Anxiety
Tidsramme: Immediately before upper gastrointestinal endoscopy
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Preprocedural anxiety will be assessed using the State Anxiety Inventory (STAI-I).
The STAI-I consists of 20 items scored on a 4-point Likert scale.
Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
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Immediately before upper gastrointestinal endoscopy
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Psychological Readiness
Tidsramme: Immediately before upper gastrointestinal endoscopy
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Psychological readiness will be assessed using a single-item question asking participants how psychologically prepared they feel for the endoscopy procedure.
Responses are scored from 1 (not at all prepared) to 5 (very well prepared), with higher scores indicating greater psychological readiness.
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Immediately before upper gastrointestinal endoscopy
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Postprocedural Satisfaction
Tidsramme: Immediately after upper gastrointestinal endoscopy
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Postprocedural satisfaction will be assessed using a single-item satisfaction question scored from 1 (not satisfied at all) to 5 (very satisfied).
Higher scores indicate greater patient satisfaction with the endoscopy procedure.
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Immediately after upper gastrointestinal endoscopy
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: DERYA ŞİMŞEKLİ, Dr., Ardahan University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ArdahanU-Simsekli-DS-07
Plan for individuelle deltakerdata (IPD)
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