- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: DERYA ŞİMŞEKLİ, PhD
- Telefoonnummer: +905545965789
- E-mail: deryasimsekli@ardahan.edu.tr
Studie Locaties
-
-
-
Erzurum, Turkije (Türkiye), 25400
- Ataturk University Research Hospital
-
Contact:
- DERYA ŞİMŞEKLİ, PhD
- Telefoonnummer: 05545965789
- E-mail: deryasimsekli@ardahan.edu.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.
|
|
Actieve vergelijker: 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.
|
Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Preprocedural Anxiety
Tijdsspanne: Immediately before upper gastrointestinal endoscopy
|
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.
|
Immediately before upper gastrointestinal endoscopy
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Psychological Readiness
Tijdsspanne: Immediately before upper gastrointestinal endoscopy
|
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.
|
Immediately before upper gastrointestinal endoscopy
|
|
Postprocedural Satisfaction
Tijdsspanne: Immediately after upper gastrointestinal endoscopy
|
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.
|
Immediately after upper gastrointestinal endoscopy
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: DERYA ŞİMŞEKLİ, Dr., Ardahan University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ArdahanU-Simsekli-DS-07
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .