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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Vaginal Blood Loss

Intervention / Treatment
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* Device: SootheVR: AppliedVR, Los Angeles, California


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>women allocated to undergo hysteroscopy with Vr System | Device: SootheVR: AppliedVR, Los Angeles, California<br>* a head-mounted display<br>|
| Experimental: Standart care<br>women allocated to undergo hysteroscopy without VR | Device: SootheVR: AppliedVR, Los Angeles, California<br>* a head-mounted display<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 minutes | 
| 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 and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, VR, Vurtual reality