Clinical trial NCT04466956: 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
Overall status: COMPLETED
Phase: NA
Conditions: Miscarriage
Keywords: Management
Anxiety
Pain
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: North Middlesex University Hospital NHS Trust
First posted: 2020-07-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention 25 and control 25
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety Rating
timeFrame: 12 months
measure: Pain Rating
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
Study officials:
affiliation: Barts & The London NHS Trust
name: Nandita Deo, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: