A Randomized Controlled Trial Investigating the Effect of Virtual Reality Glasses on Anxiety and Pain Levels in Women During Gynecological Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Score (STAI-I)
研究概览
简要总结
This randomized controlled trial aims to examine the effects of using virtual reality (VR) glasses during gynecological examinations on women's pain and anxiety levels. A total of 126 women were randomly assigned to either an intervention group, who used VR glasses during the examination, or a control group, who received standard care. Visual and auditory stimuli from nature-themed videos were shown to the intervention group using VR glasses during the procedure. Participants' pain was assessed using the Visual Analog Scale (VAS), and anxiety was measured using the State-Trait Anxiety Inventory (STAI-I). The study was conducted between February and November 2024 at the Department of Obstetrics and Gynecology, Erciyes University Hospital.
详细描述
This study was designed to investigate the effect of virtual reality (VR) glasses on pain and anxiety levels experienced by women during gynecological examinations. It was conducted as a randomized controlled experimental study between February and November 2024 at Erciyes University Gevher Nesibe Hospital, Department of Obstetrics and Gynecology.
A total of 126 participants were randomly assigned to intervention and control groups (63 each). Inclusion criteria included women aged between 19 and 49 years, literate, and voluntarily agreeing to participate. Women with gynecological cancer, communication impairments, or visual/auditory disabilities were excluded.
The intervention group received standard gynecological examination procedures along with VR glasses showing immersive nature videos during the examination. The control group underwent the examination without VR intervention. Data collection tools included a Personal Information Form, Pain Beliefs Questionnaire, the Visual Analog Scale (VAS) for pain, and the State-Trait Anxiety Inventory-I (STAI-I) for anxiety. In addition, a Satisfaction Form was applied to the intervention group after the examination.
The aim of the study was to determine whether VR application can reduce perceived pain and anxiety during gynecological procedures. The findings of this study are expected to contribute to non-pharmacological nursing interventions in women's health practices.
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
- None
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 19 and 49 years
- •Literate and able to complete the questionnaire
- •Agree to participate voluntarily
- •Undergoing gynecological examination
排除标准
- •Having a diagnosed gynecological cancer
- •Hearing or visual impairments
- •Cognitive or communication difficulties
- •History of psychiatric illness
- •Refusal to wear VR glasses
结局指标
主要结局
Change in State Anxiety Score (STAI-I)
时间窗: Baseline (immediately before the examination) and Post-procedure (within 15 minutes after the examination)
The State Anxiety Inventory (STAI-I) consists of 20 self-report items that measure how the individual feels at a specific moment. Each item is rated on a 4-point Likert scale: 1 (Not at all) to 4 (Very much so). The scale includes both direct and reverse-scored items. Reverse-scored items include items 1, 2, 5, 8, 10, 11, 16, 19, and 20. The total score is calculated by subtracting the sum of reverse-scored items from the sum of direct items and then adding 50. Total scores range from 20 to 80, with higher scores indicating greater anxiety. The questionnaire will be administered immediately before and 15 minutes after the gynecological examination. The change in scores will be analyzed to evaluate the intervention's effectiveness.
Visual Analog Scale for Pain (VAS)
时间窗: Post-procedure (within 10 minutes after the gynecological examination)
The Visual Analog Scale for Pain (VAS) is a widely used unidimensional tool designed to assess subjective pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" on the left end and "worst imaginable pain" on the right. Participants will be asked to place a mark along the line that best reflects the intensity of their current pain. The distance (in centimeters) from the left end to the mark will be measured, yielding a score between 0 and 10, with higher scores indicating greater pain intensity. The VAS will be administered once, within 10 minutes following the gynecological examination.
次要结局
- Pain Beliefs Questionnaire - PBQ)(Baseline (within 30 minutes before the gynecological examination))
研究者
Fazilet Nur Daşkın
MSc Student in Nursing
TC Erciyes University