Trial Outcomes & Findings for Virtual Reality in MVA for Miscarriage (NCT NCT04466956)

Results Overview

Anxiety score (numerical rating score 0 least-10 worst) and questionnaire

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

12 months

Results posted on

2024-11-25

Participant Flow

July 2021- July 2022 across 2 sites: Whipps Cross University Hospital (WCUH) and North Middlesex University Hospital (NMUH). Consecutive women with retained products of pregnancy post miscarriage or abortion attending emergency gynaecology/early pregnancy units at both sites were offered inclusion if they fulfilled inclusion criteria.

In both participating hospitals, MVAs are offered as an option for management of missed or incomplete miscarriage, or retained pregnancy tissue after abortion. Eligibility criteria included patients aged 18 - 50 years who were able to give written, informed consent. Patients were excluded if they were unable to speak fluent English; had hearing or visual impairments; or a history of epileptic seizures or claustrophobia

Participant milestones

Participant milestones
Measure	Virtual Reality for Reduction of Pain and Anxiety During MVA 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience Virtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure	Control Group- no VR 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality for Reduction of Pain and Anxiety During MVA n=25 Participants 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience Virtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure	Control Group- no VR n=25 Participants 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Continuous	32 years STANDARD_DEVIATION 6.9 • n=25 Participants	33 years STANDARD_DEVIATION 5.1 • n=25 Participants	32.5 years STANDARD_DEVIATION 6.4 • n=50 Participants
Sex/Gender, Customized Female	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weeks gestation	9.3 weeks STANDARD_DEVIATION 2.1 • n=25 Participants	9.0 weeks STANDARD_DEVIATION 2.1 • n=25 Participants	9.15 weeks STANDARD_DEVIATION 2.1 • n=50 Participants

PRIMARY outcome

Timeframe: 12 months

Anxiety score (numerical rating score 0 least-10 worst) and questionnaire

Outcome measures

Outcome measures
Measure	Virtual Reality for Reduction of Pain and Anxiety During MVA n=25 Participants 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience Virtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure	Control Group- no VR n=25 Participants 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
Anxiety Rating	4.4 score on a scale Standard Deviation 3.2	3.94 score on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 12 months

Pain score (numerical rating score 0 least-10 worst) and questionnaire

Outcome measures

Outcome measures
Measure	Virtual Reality for Reduction of Pain and Anxiety During MVA n=25 Participants 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience Virtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure	Control Group- no VR n=25 Participants 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
Pain Rating	5.54 score on a scale Standard Deviation 2.2	4.68 score on a scale Standard Deviation 2.3

Adverse Events

Virtual Reality for Reduction of Pain and Anxiety During MVA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group- no VR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Anna McDougall

Barts Health NHS Trust

Phone: 02078827272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place