Virtual Reality and Outpatient Hysteroscopy

NCT03699280 | Completed Results DMC

• 1 other identifier: 18IC4481
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

TITLE Virtual Reality (VR) as a Distraction technique for management of acute pain at Outpatient Hysteroscopy DESIGN Randomised Control Trial (RCT) with Mixed methods - Qualitative and quantitative AIMS To study the role of distraction techniques for management of acute pain in Outpatient Hysteroscopy and to assess feasibility of using Virtual Reality for managing pain. Primary objective:

• Feasibility of using virtual reality as a distraction technique in management of acute pain in patients undergoing Outpatient Hysteroscopy. Secondary objectives:
• Understanding the acceptability and effectiveness of VR interventions within the procedural groups and how these might vary as a function of different patient demographics.
• Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
• Understanding how best to implement the technology and designing of the contents of the VR intervention.
• Understanding the effective mechanisms for the analgesic effect of VR and explore how this could be tailored to individual patients. POPULATION Patients attending the Outpatient Hysteroscopy clinics ELIGIBILITY Patients undergoing Outpatient Hysteroscopy DURATION 6 months

Conditions

Acute Pain; Hysteroscopy

Keywords

virtual reality, hysteroscopy, acute pain, distraction technique

Outcome Measures

Primary Outcomes (3)

• Worst Pain Scores

  This outcome measure assessed the feasibility of using virtual reality as a distraction technique in the management of acute pain in patients undergoing Outpatient Hysteroscopy. 'Worst pain scores' indicated the most pain experienced during the procedure, even if momentary. It was based on a numeric rating score (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). The outcome value refers to the worst pain experienced by the participant during the Hysteroscopy procedure.

  during the hysteroscopy procedure, an average of 10 minutes

• Average Pain Scores

  This outcome measure assessed the average pain experienced by the participants during the hysteroscopy procedure with virtual reality intervention. The pain scores were based on numeric rating scores (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). Data from the two time points in the time frame were combined and calculated as an average.

  10 minutes immediately before and after the procedure

• Anxiety Scores

  Anxiety scores were measured on a numeric rating score (scale of 0-10, with 0 representing 'no anxiety' and 10 representing 'worst imaginable anxiety'). The anxiety scores measured during the procedure were reported in this outcome measure.

  during the hysteroscopy procedure, an average of 10 minutes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

VR video to be played during the procedure

Other: Virtual Reality

Standard Procedure

NO INTERVENTION

Routine protocol outpatient hysteroscopy

Interventions

Virtual Reality OTHER

Oculus Go VR device

Virtual Reality

Eligibility Criteria

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

You may not qualify if:

• Patients:
• Hearing impairments and blindness
• Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conization, Manchester Fothergill).
• The denial or withdrawal of oral informed consent Staff: The denial or withdrawal of informed consent

Sponsors & Collaborators

• Imperial College London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

Whipps Cross University Hospital

London, IG8 9LQ, United Kingdom

Location

Related Publications (2)

• Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.

  PMID: 30052655 BACKGROUND

• Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22.

  PMID: 32575151 RESULT

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ms Nandita Deo
• Organization: Imperial College London

nandita.deo@gmail.com

07939360357

Study Officials

• Nandita Deo, FRCOG

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomised control trial involving mixed methods of qualitative and quantitative analysis. The study will include 40 patients attending the outpatient hysteroscopy clinic and randomised to either a VR intervention group or standard procedure by computer-generated randomisation. All patients will fill in a questionnaire before and after the procedure. Patients who have been randomised to the VR arm will have a semi-structured interview regarding their experience with VR. The clinician performing the procedure will fill in a questionnaire per patient regarding the ease of the procedure and perceived pain levels of the patient. The Clinician performing the procedure and nursing staff's perception regarding feasibility of using the VR equipment for each patient who had the intervention was also assessed through the questionnaire.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 9, 2018
• Study Start: August 4, 2018
• Primary Completion: October 6, 2018
• Study Completion: October 6, 2018
• Last Updated: February 2, 2023
• Results First Posted: February 2, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)