Miscarriage
Conditions
Keywords
Management, Anxiety, Pain
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.
Interventions
DEVICEVirtual reality
Virtual reality headset worn with short relaxing video played during MVA procedure
Sponsors
North Middlesex University Hospital NHS Trust
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention 25 and control 25
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Rating | 12 months | Anxiety score (numerical rating score 0 least-10 worst) and questionnaire |
| Pain Rating | 12 months | Pain score (numerical rating score 0 least-10 worst) and questionnaire |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Control Group- no VR 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Virtual Reality for Reduction of Pain and Anxiety During MVA | Control Group- no VR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 6.9 | 33 years STANDARD_DEVIATION 5.1 | 32.5 years STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Female | 25 participants | 25 participants | 50 participants |
| Weeks gestation | 9.3 weeks STANDARD_DEVIATION 2.1 | 9.0 weeks STANDARD_DEVIATION 2.1 | 9.15 weeks STANDARD_DEVIATION 2.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Anxiety Rating
Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality for Reduction of Pain and Anxiety During MVA | Anxiety Rating | 4.4 score on a scale | Standard Deviation 3.2 |
| Control Group- no VR | Anxiety Rating | 3.94 score on a scale | Standard Deviation 2.4 |
Primary
Pain Rating
Pain score (numerical rating score 0 least-10 worst) and questionnaire
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality for Reduction of Pain and Anxiety During MVA | Pain Rating | 5.54 score on a scale | Standard Deviation 2.2 |
| Control Group- no VR | Pain Rating | 4.68 score on a scale | Standard Deviation 2.3 |
Comparison: Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.p-value: <0.01t-test, 1 sided