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| Name | Class |
|---|---|
| North Middlesex University Hospital NHS Trust | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality for reduction of pain and anxiety during MVA | Active Comparator | 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience |
|
| Control group- no VR | No Intervention | 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Virtual reality headset worn with short relaxing video played during MVA procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Rating | Anxiety score (numerical rating score 0 least-10 worst) and questionnaire | 12 months |
| Pain Rating | Pain score (numerical rating score 0 least-10 worst) and questionnaire | 12 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Nandita Deo, MRCOG | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whipps Cross University Hospital | London | E11 1NR | United Kingdom | |||
| North Middlesex University Hospital |
Plan to publish results
At completion of study anticipated 2022
Public
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group- no VR | 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
50 patients agreed to participate from the 72 eligible women approached and offered inclusion
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anxiety Rating | Anxiety score (numerical rating score 0 least-10 worst) and questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
1 year (July 2021-July 2022)
No adverse events occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anna McDougall | Barts Health NHS Trust | 02078827272 | anna.mcdougall@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2021 | Nov 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
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Intervention 25 and control 25
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| London |
| N18 1QX |
| United Kingdom |
| Control Group- no VR |
25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weeks gestation | Mean | Standard Deviation | weeks |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pain Rating | Pain score (numerical rating score 0 least-10 worst) and questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Group- no VR | 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data. |