Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Not Applicable

• Conditions: Dysplasia, Cervix

• Registration Number: NCT04742543
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Status Verified: 2022-05
• Study Start: 2022-05-19
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-02
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion Criteria

• patients under 18 years
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessments of pain through pain score parameter	20 minutes	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
Assessments of pain through physiological parameters	20 minutes	Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute

Trial Locations

Locations (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel