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

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.

Completed

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Key information

Conditions

Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage Vaginal Blood Loss

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SootheVR: AppliedVR, Los Angeles, California

Device

a head-mounted display

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.

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Nov 12, 2020
Registry last updated: Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed