Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial

Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04802460

Acronym

Enrollment

Registered

2021-03-17

Start date

2020-05-01

Completion date

2021-02-02

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and Hysteroscopy

Brief summary

The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.

Detailed description

The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS). A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.

Interventions

DEVICEVirtual reality headset (The Guided Meditation VR App through Oculus Go headset)

Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.

Design outcomes

Primary

Measure	Time frame	Description
pain scale	10 minutes	The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).

Secondary

Measure	Time frame	Description
heart rate changes	10 minutes	The secondary outcomes will be change in pain score and change in participant's HR throughout the procedure to assess for sympathetic evidence of pain and anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026