Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Study Overview
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Brief Summary
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To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia

Detailed Description
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A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.

Official Title
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Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Conditions
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Dysplasia, Cervix

Intervention / Treatment
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* Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years referred for conization of cervix due to cervical dysplasia Exclusion Criteria: patients under 18 years pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: : Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality glasses<br>Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure with Virtual reality glasses on | Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display<br>* For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be swimming with dolphins or any other content chosen by the participant<br>|
| No Intervention: No intervention. standard treatment<br>Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure without virtual reality glasses (no intervention) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of pain through pain score parameter | Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain in which 0 is no pain and 10 is the worst imaginable pain | 20 minutes | 
| Assessments of pain through physiological parameters | Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical dysplasia; conization; anxiety; pain; virtual reality