The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual Reality-Based Intervention: During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses

30 control group: Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Primary Outcome Measure — From before the colposcopy procedure begins until after it is completed
  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
• In this study, anxiety (DSKE-KF), perceived stress (PSS-10), and pain (VAS) were identified as co-primary outcome measures. — 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
  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.

Trial sites (1)

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