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

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Infertility; Vaginal Blood Loss

Treatments: Device: SootheVR: AppliedVR, Los Angeles, California

Study type: Interventional

Funder types: Other

Identifiers

NCT04625920

0793-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual reality

Experimental group

Description:

women allocated to undergo hysteroscopy with Vr System

Treatment:

Device: SootheVR: AppliedVR, Los Angeles, California

Standart care

Experimental group

Description:

women allocated to undergo hysteroscopy without VR

Treatment:

Device: SootheVR: AppliedVR, Los Angeles, California