The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial (Colposcopy)
10. juni 2026 oppdatert av: Çiler ÇOKAN DÖNMEZ, Osmaniye Korkut Ata University
Due to its invasive nature, the colposcopy procedure can cause high levels of anxiety, stress, pain, and nausea in women.
The uncertainty surrounding the condition to be diagnosed, combined with the discomfort caused by the procedure itself, creates significant psychological stress in women and can negatively impact their compliance with diagnosis and treatment.
Therefore, it is believed that applying Virtual Reality (VR) technology-one of the distraction techniques-as a non-pharmacological method for women undergoing colposcopy could be effective in reducing pain and anxiety by diverting their cognitive attention away from the procedure's negative stimuli.
Although there are many studies in the literature using VR technology, no study has been found that examines the effect of VR-based interventions on anxiety, stress, and pain levels in women undergoing colposcopy.
Therefore, this study will be one of the first randomized controlled trials to examine the multidimensional effects of virtual reality (anxiety, stress, pain) in women undergoing colposcopy.
The findings will contribute to the widespread adoption of non-pharmacological nursing interventions in clinical practice.
The aim of this study is to comprehensively evaluate the effect of a virtual reality (VR)-based intervention on anxiety, stress, and pain levels in women undergoing colposcopy and to determine its efficacy compared to standard care.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: ÇİLER ÇOKAN DÖNMEZ, PhD
- Telefonnummer: +903443001000
- E-post: cilerdonmez@hotmail.com
Studiesteder
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Adana
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Adana, Adana, Tyrkia (Türkiye), 01250
- Rekruttering
- Çukurova University Hospital
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Ta kontakt med:
- Cukurova Üniversitesi Hastanesi Balcalı Hastanesi
- Telefonnummer: 03223386060
- E-post: ghanim.khatib@gmail.com
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Underetterforsker:
- Esra Ünal, PhD
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Underetterforsker:
- Ganim Khatip, Medical Doctor Prof
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
Be 18 years of age or older, Have colposcopy scheduled due to a cervical cytology result of LSIL, HSIL, ASC-US, or HPV positivity, Be able to read and understand Turkish, Provide voluntary written informed consent -
Exclusion Criteria:
Diagnosis of a mental disorder Severe visual impairment, claustrophobia, cognitive impairment History of severe motion sickness (cybersickness) associated with virtual reality use Use of anxiolytic/analgesic medication prior to the procedure Individuals with severe cognitive impairment or communication difficulties
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Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 30 control group
The control group will receive standard care.No intervention will be performed on the control group.
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Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
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Eksperimentell: 30 Intervention group
During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
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During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Primary Outcome Measure
Tidsramme: From before the colposcopy procedure begins until after it is completed
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The Perceived Stress Scale consists of 10 items on a 5-point Likert scale and two dimensions.
In our study, we used the 10-item version of the Perceived Stress Scale.
Scores on the Perceived Stress Scale range from 0 to 40.
A high score on the scale indicates a high level of stress
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From before the colposcopy procedure begins until after it is completed
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In this study, anxiety (DSKE-KF), perceived stress (PSS-10), and pain (VAS) were identified as co-primary outcome measures.
Tidsramme: The virtual reality headset application will be launched immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finish
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The State-Trait Anxiety Inventory (STAI), developed by Spielberger and colleagues in 1970 and adapted to the Turkish population by Öner and Le Compte in 1985, was revised by Zsido et al. (2020) to create a short form of the inventory by reducing the number of items.
The short form is a 4-point Likert-type inventory consisting of a total of 10 items-5 for state anxiety and 5 for trait anxiety (Zsido et al., 2020; Öner and Le Compte, 1983).
Individuals scoring 10 or higher on the DKE-KF and 14 or higher on the SKE-KF are considered clinically anxious.
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The virtual reality headset application will be launched immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finish
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Secondary Outcome Measure
Tidsramme: The SG application will be initiated immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finished.
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The Visual Analog Scale (VAS) is a safe, easy-to-use measurement tool developed to determine the intensity of an individual's pain.
The VAS consists of a 10-centimeter line with subjective descriptive labels at each end of the scale (0 cm = no pain and 10 cm = unbearable pain).
The individual marks the point on this 10-cm line that corresponds to their own pain level.
A low score on the VAS indicates that the individual's pain intensity is low or mild, while a high score indicates that the pain intensity is high or severe.
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The SG application will be initiated immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finished.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 1. Baradwan, S., Alshahrani, M. S., AlSghan, R., Alyafi, M., Elsayed, R. E., Abdel-Hakam, F. A. A. M., ... & Badran, H. (2024). The effect of virtual reality on pain and anxiety management during outpatient hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Archives of Gynecology and Obstetrics, 309(5), 1267-1280. DOI: 10.1007/s00404-023-07319-8 2. Dascal, J., Reid, M., IsHak, W. W., Spiegel, B., & Tanner, V. (2017). Virtual reality and medical inpatients: a systematic review of randomized, controlled trials. Innovations in clinical neuroscience, 14(1-2), 14-21. PMC (Tam Metin): https://pmc.ncbi.nlm.nih.gov/articles/PMC5373791/ 3. Deo, N., Khan, K. S., Mak, J., Allotey, J., Gonzalez Carreras, F. J., Fusari, G., & Benn, J. (2020). Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 127(11), 1361-1370. DOI: 10.1111/1471-0528.16377 4. Hecken, J. M., Halagiera, P., Rehman, S., Tempfer, C. B., & Rezniczek, G. A. (2021). Virtual Reality for Anxiety Reduction in Women Undergoing Colposcopy: A Randomized Controlled Trial. The Journal of Minimally Invasive Gynecology, 28(8), 1445-1451. DOI: 10.1016/j.jmig.2021.01.016 5. Öner, N., & Le Compte, A. (1983). Durumluk-Sürekli Kaygı Envanteri El Kitabı. Boğaziçi Üniversitesi Yayınları. 6. Cohen, S. Kamarck, T. ve Mermelstein, R. (1983). A global measure of perceived stress. Journal Of Health And Social Behavior, 85-396. 7. Eskin, M. Harlak, H. Demirkıran, F. ve Dereboy, Ç. (2013). Algılanan Stres Ölçeğinin Türkçeye Uyarlanması. New Symposium Journal, 51(1). 8. Wewers, M. E., Lowe, N. K. (1990). A critical review of visual analogue scales in the measurement of clinical phenomena. Research in Nursing & Health 13, 227-236. 9. Larroy, C. (2002). Comparing visual-analog and numeric scales for assessing menstrual pain. Behavioral Medicine, 27(4), 179-181. 10. Pelazas-Hernández, J. A., Varillas-Delgado, D., G
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. oktober 2026
Datoer for studieregistrering
Først innsendt
10. juni 2026
Først innsendt som oppfylte QC-kriteriene
10. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-58565088-100-275994
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Due to data privacy requirements, individual patient information is not disclosed.
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