N/A N=50 Randomized Treatment

Virtual Reality in MVA for Miscarriage

Miscarriage

Bottom Line

View on ClinicalTrials.gov: NCT04466956 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Anxiety Rating — 4.4; 3.94 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Virtual reality (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Barts & The London NHS Trust
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Anxiety Rating	4.4; 3.94	—
PRIMARY Pain Rating	5.54; 4.68	<0.01 sig

Summary

We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration. Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed. VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.

Eligibility Criteria

Inclusion Criteria

Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.

Exclusion Criteria

Hearing impairments and blindness
History of epilepsy or any previous seizures
Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)
Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation >12 weeks)
The denial or withdrawal of informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04466956). 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.