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Not yet recruiting NCT07462039

Effect of Virtual Reality on Pain and Anxiety During Pap Smear Testing

No phase Interventional Nurse's Role Pain Management Cervical Cancer Screening Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality.
Who it may be relevant to
Registry conditions: Nurse's Role, Pain Management, Cervical Cancer Screening, Anxiety. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Virtual Reality Transition on Pain and Anxiety Experienced During Pap Smear Testing

Overview

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.

Detailed description

This study was planned as a randomized controlled, pretest-posttest true experimental design to evaluate the effect of a virtual reality (VR) application on pain and anxiety levels experienced by women during Pap smear sampling. Although cervical cancer is preventable, it remains a significant cause of morbidity and mortality among women worldwide. Despite the availability of regular screening programs, many women are reluctant to undergo Pap smear testing due to factors such as pain, anxiety, and concerns about privacy during gynecological examinations. Therefore, there is a need for innovative and non-invasive methods to reduce negative experiences during the procedure.

The study will be conducted at the Gynecology and Obstetrics Outpatient Clinic of Gazimağusa Yaşam Hospital. The sample will consist of 60 women aged 18-65 years who meet the inclusion criteria and voluntarily agree to participate. Participants will be randomly assigned to either the intervention group (VR headset applied) or the control group (standard care) using a simple randomization method.

Women in the intervention group will watch a 360° relaxing nature video through a virtual reality headset during the Pap smear procedure. The control group will receive the standard clinical procedure. Data will be collected using a Personal Information Form, the State Anxiety Inventory, and the Visual Analog Scale (VAS). Anxiety levels will be assessed before and after the procedure, and pain levels will be evaluated after the procedure.

The findings are expected to demonstrate the effectiveness of virtual reality in reducing pain and anxiety during Pap smear procedures and to contribute to evidence-based practices aimed at increasing women's participation in cervical cancer screening programs.

Interventions

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

Primary outcome measures

  • Pain level during Pap smear procedure [Time frame: Immediately after completion of the Pap smear procedure (within 5 minutes post-procedure).]
  • State anxiety level [Time frame: Immediately before the procedure and immediately after the procedure.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07462039 · ETK-00-2025-0190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗