A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Assessments of pain through physiological parameters
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
michal roll
Director, Head of Clinical Trails Department, Principal Investigator, Clinical Professor
Tel-Aviv Sourasky Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Assessments of pain through physiological parameters
Time Frame: 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
Time Frame: 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.