Virtual Reality in MVA for Miscarriage
Primary Purpose
Miscarriage
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage focused on measuring Management, Anxiety, Pain
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
Sites / Locations
- Whipps Cross University HospitalRecruiting
- North Middlesex University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Virtual reality for reduction of pain and anxiety during MVA
Control group- no VR
Arm Description
25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience
25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
Outcomes
Primary Outcome Measures
Anxiety rating
Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Pain rating
Pain score (numerical rating score 0 least-10 worst) and questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04466956
First Posted
July 7, 2020
Last Updated
December 2, 2022
Sponsor
Barts & The London NHS Trust
Collaborators
North Middlesex University Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04466956
Brief Title
Virtual Reality in MVA for Miscarriage
Official Title
Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
North Middlesex University Hospital NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.
The rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration
Primary objective
• Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.
Secondary objectives
Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage
Keywords
Management, Anxiety, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention 25 and control 25
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality for reduction of pain and anxiety during MVA
Arm Type
Active Comparator
Arm Description
25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience
Arm Title
Control group- no VR
Arm Type
No Intervention
Arm Description
25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality headset worn with short relaxing video played during MVA procedure
Primary Outcome Measure Information:
Title
Anxiety rating
Description
Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Time Frame
12 months
Title
Pain rating
Description
Pain score (numerical rating score 0 least-10 worst) and questionnaire
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna A McDougall, MRCOG
Phone
07739846763
Email
anna.mcdougall@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Nandita Deo, MRCOG
Phone
07939 360357
Email
nandita.deo@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nandita Deo, MRCOG
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whipps Cross University Hospital
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandita Deo, MRCOG
Email
nandita.deo@nhs.net
Facility Name
North Middlesex University Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna A McDougall, MRCOG
Phone
07739846763
Email
Anna.mcdougall@nhs.net
First Name & Middle Initial & Last Name & Degree
Schahrazed Rouabhi
Email
schahrazed.rouabhi@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to publish results
IPD Sharing Time Frame
At completion of study anticipated 2022
IPD Sharing Access Criteria
Public
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Virtual Reality in MVA for Miscarriage
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