A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy

Not Applicable

Completed

• Conditions: Vaginal Blood Loss; Infertility

• Registration Number: NCT04625920
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting.

Detailed Description

A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo operative hysteroscopy either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Study Timeline

• Study Start: 2020-04-10
• Primary Completion: 2020-09-20
• Study Completion: 2020-09-30
• Study First Submitted: 2020-10-27
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-08
• Last Update Submitted: 2020-11-08
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

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

Inclusion Criteria

• . Women with suspected infection
• women considered not suitable to undergo an office hysteroscopy
• women who reported the use of analgesia 6 hours prior to the procedure.

Exclusion Criteria

• patient needed office hysteroscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessments of pain through physiological parameters	10 minutes	Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
Assessments of pain through pain score parameter	10 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 and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.

Trial Locations

Locations (2)

Souraski MC; 🇮🇱 Tel Aviv, Israel

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