Çukurova University Hospital
Adana, 01250, Turkey (Türkiye)
Location status: Recruiting
Location contact
Cukurova Üniversitesi Hastanesi Balcalı Hastanesi
CONTACT
Esra Ünal, PhD
SUB_INVESTIGATOR
Ganim Khatip, Medical Doctor Prof
SUB_INVESTIGATOR
NCT Number: NCT07650422
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Adana, 01250, Turkey (Türkiye)
Location status: Recruiting
Cukurova Üniversitesi Hastanesi Balcalı Hastanesi
CONTACT
Esra Ünal, PhD
SUB_INVESTIGATOR
Ganim Khatip, Medical Doctor Prof
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
Time frame: 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
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Osmaniye Korkut Ata University
Other
Acronym: Colposcopy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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