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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625920
• Other study ID #: 0793-19
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Vaginal Blood Loss

Intervention

Device:
• SootheVR: AppliedVR, Los Angeles, California
a head-mounted display

Locations

Country	Name	City	State
Israel	Lis Maternity Hospital, Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Souraski MC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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