N/A N=40 Randomized Single-blind Other

Virtual Reality and Outpatient Hysteroscopy

Acute Pain · Hysteroscopy

Bottom Line

View on ClinicalTrials.gov: NCT03699280 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Worst Pain Scores — 5.65; 7.85 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Virtual Reality (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Imperial College London
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Worst Pain Scores	5.65; 7.85	—
PRIMARY Average Pain Scores	3.7; 6	—
PRIMARY Anxiety Scores	3.33; 5.45	—

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

Eligibility Criteria

Inclusion Criteria

Patients: Inclusion criteria will include all women of at least 18 - 70 years of age, planned for an office hysteroscopy.

Staff: Inclusion criteria will include the clinician performing the outpatient hysteroscopy and the nurse supporting the clinic.

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03699280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.