NCT07462039

Brief Summary

This randomized controlled pretest-posttest experimental study aims to evaluate the effect of virtual reality (VR) on pain and anxiety levels experienced during Pap smear sampling. Although cervical cancer is largely preventable through regular screening, many women avoid Pap smear testing due to anxiety, fear of pain, and discomfort during gynecological examinations. Innovative, non-invasive interventions are needed to improve women's screening experiences and participation rates. The study will be conducted in a gynecology outpatient clinic with 60 women aged 18-65 years who meet the inclusion criteria and provide informed consent. Participants will be randomly assigned to either the intervention group (VR headset during the procedure) or the control group (standard care). Women in the intervention group will watch a 360° relaxing nature video during the Pap smear procedure. Data will be collected using a Personal Information Form, the State Anxiety Inventory, and the Visual Analog Scale (VAS). The findings may support integrating VR into clinical practice to enhance patient comfort during screening procedures.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Mar 2026May 2026

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 3, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

virtual realitypap smearpainanxietyCervical Cancer Screening

Outcome Measures

Primary Outcomes (2)

  • Pain level during Pap smear procedure

    Pain intensity experienced during the Pap smear procedure will be measured using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

    Immediately after completion of the Pap smear procedure (within 5 minutes post-procedure).

  • State anxiety level

    Anxiety level will be assessed using the State Anxiety Inventory before and after the Pap smear procedure. Higher scores indicate higher anxiety levels.

    Immediately before the procedure and immediately after the procedure.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants will watch a 360° relaxing nature video through a VR headset during the Pap smear procedure.

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

Routin nursing care

Interventions

Virtual RealityBEHAVIORAL

Participants will watch a 360° relaxing nature video through a VR headset during the Pap smear procedure.

Virtual Reality Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPap Smear
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-65 years
  • Scheduled for a Pap smear procedure
  • Able to communicate in Turkish
  • Able to understand and complete the study questionnaires
  • Willing to provide written informed consent
  • No visual or hearing impairment preventing the use of a VR headset

You may not qualify if:

  • History of severe motion sickness or vertigo
  • Diagnosed psychiatric disorder affecting anxiety assessment
  • Use of anxiolytic or sedative medication within 24 hours prior to the procedure
  • Presence of acute pelvic pain or active vaginal infection
  • Previous participation in this study
  • Any condition preventing safe use of a VR headset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Arzu Abiç, PhD

CONTACT

Buse Güney

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the study hypothesis. The intervention group will receive virtual reality during the Pap smear procedure, while the control group will receive standard care.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the virtual reality intervention group or the control group. Women in the intervention group will receive virtual reality distraction during the Pap smear procedure, while the control group will receive standard care. Pain and anxiety levels will be compared between the groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

May 10, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03