Anxiety, Colposcopy, Stress, Virtual Reality-Based Intervention, Women
Conditions
Keywords
Women, Colposcopy, Virtual Reality-Based Intervention, Anxiety, Stress, Pain
Brief 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.
Interventions
During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
OTHER30 control group
Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
Sponsors
Osmaniye Korkut Ata University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Blinding: The study will be conducted as evaluator-blind (single-blind). The researcher collecting data and performing measurements will not know which group the participants are in. The virtual reality application will be administered by a staff member who is not part of the research team and is not involved in the data collection process.
Intervention model description
This study is a single-center, two-group (1:1), randomized controlled, assessor-blinded experimental study designed to evaluate the effect of a virtual reality (VR)-based intervention on anxiety, perceived stress, and pain in women undergoing colposcopy. The intervention group will receive VR during colposcopy, while the control group will receive standard care.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be 18 years of age or older, Have colposcopy scheduled due to a cervical cytology result of LSIL, HSIL, ASC-US, or HPV positivity, Be able to read and understand Turkish, Provide voluntary written informed consent -
Exclusion criteria
Diagnosis of a mental disorder Severe visual impairment, claustrophobia, cognitive impairment History of severe motion sickness (cybersickness) associated with virtual reality use Use of anxiolytic/analgesic medication prior to the procedure Individuals with severe cognitive impairment or communication difficulties \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | The SG application will be initiated 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 finished. | The Visual Analog Scale (VAS) is a safe, easy-to-use measurement tool developed to determine the intensity of an individual's pain. The VAS consists of a 10-centimeter line with subjective descriptive labels at each end of the scale (0 cm = no pain and 10 cm = unbearable pain). The individual marks the point on this 10-cm line that corresponds to their own pain level. A low score on the VAS indicates that the individual's pain intensity is low or mild, while a high score indicates that the pain intensity is high or severe. |
Countries
Turkey (Türkiye)
Contacts
CONTACTÇİLER ÇOKAN DÖNMEZ, PhD
Outcome results
None listed