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临床试验/NCT07462039
NCT07462039尚未招募不适用

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

Eastern Mediterranean University0 个研究点目标入组 60 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Pain level during Pap smear procedure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Virtual Reality Group

Experimental

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

干预措施: Virtual Reality (Behavioral)

Control Group

No Intervention

Routin nursing care

结局指标

主要结局

Pain level during Pap smear procedure

时间窗: Immediately after completion of the Pap smear procedure (within 5 minutes post-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.

State anxiety level

时间窗: Immediately before the procedure and immediately after the procedure.

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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