Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient Hysteroscopy?

NCT05307887 | Completed Results

• 1 other identifier: 21SM7296
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Hysteroscopy is a common procedure where a camera attached to a thin scope is passed into the uterus via the vagina and cervix in order to obtain views of the inside of the uterus. Hysteroscopy is used for the diagnosis and management of a variety of benign and conditions as well as the diagnosis of uterine cancer. It can be performed under general anaesthetic or in an outpatient setting without formal anaesthetic. The latter has several advantages when compared to hysteroscopy with general anaesthesia as it avoids the additional risk of general anaesthesia, has a quicker recovery time, shorter hospital stay and reduced cost. However, women may experience discomfort or pain during an outpatient procedure and pain is one of the most common reasons for failure to complete the procedure. The most appropriate way to manage pain and anxiety during outpatient hysteroscopy is not yet fully understood and conventional therapy, as recommended by the Royal College of Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to the procedure and sometimes local anaesthetic during the procedure. In recent years virtual reality software has been developed and used in a variety of different settings to alleviate pain and anxiety during medical procedures. This study aims to investigate whether the use of virtual reality as an adjunct to conventional pain management can reduce anxiety and pain during outpatient hysteroscopy. The study will take the form of a randomised controlled trial at St Mary's hospital London. A randomly selected group of patients undergoing outpatient hysteroscopy with conventional management plus the addition of virtual reality software will be compared to a control group of patients undergoing the procedure with conventional management only.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• Reported Numeric Rating Score (NRS) Pain Score

  Self reported procedure related pain score (0-11 with higher numbers indicating increased pain).

  Following completion of the procedure( within 20 minutes of completion).

• Reported Numeric Rating Score (NRS) Anxiety Score

  Self reported procedure related anxiety score (0-11 with higher numbers indicating higher anxiety levels).

  Following completion of the procedure( within 20 minutes of completion).

Secondary Outcomes (3)

• Procedure Time

  From start to end of procedure

• Patient Pain Control Satisfaction

  Following completion of the procedure( within 20 minutes of completion).

• Side Effects

  during procedure

Study Arms (2)

Virtual Reality Technology

EXPERIMENTAL

Group receiving virtual reality technology in addition to standard therapy

Device: Sync VR Medical PICO G2 4K Virtual Reality Technology

Standard Therapy Control Group

NO INTERVENTION

Interventions

Sync VR Medical PICO G2 4K Virtual Reality Technology DEVICE

Virtual reality headset and software

Virtual Reality Technology

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-70 2. Patients undergoing outpatient hysteroscopy for any indication 3. Capacity to give informed consent 4. Cognitive and linguistic ability sufficient to understand and fill out the NRS questionnaire.

You may not qualify if:

• \. Epilepsy 2. Severe vertigo 3. Hearing impairment 4. Current facial injury /burn 5. Patients who have not given informed consent 6. Patients aged less than 18 or more than 70.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

St Mary's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Thomas Sewell
• Organization: Imperial College NHS Foundation Trust

thomas.sewell2@nhs.net

02033122152

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: April 25, 2022
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)