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Trial registered on ANZCTR


Registration number
ACTRN12622000088741p
Ethics application status
Submitted, not yet approved
Date submitted
9/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality for pain relief during intrauterine device insertion
Scientific title
Virtual Reality for analgesia during intrauterine device insertion
Secondary ID [1] 305887 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain during intrauterine device (IUD) insertion 324437 0
Condition category
Condition code
Reproductive Health and Childbirth 321930 321930 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual reality (VR) is a technology that uses a headset to create a 3-dimensional interactive environment for the user. The user is therefore distracted from the real-world environment where the procedure is being done. It has been shown to be helpful for improving pain in other settings, for example burn victims.

This research project aims to find whether VR can help reduce the discomfort of having an IUD inserted in the outpatient clinic setting. It also aims to discover whether it can help patients who feel anxious, and overall make it easier for the clinician to insert the IUD.

Screening will occur in the Gynaecology outpatient clinic setting. Patients who are having IUD insertion in the clinic setting will be identified and approached for consent. Participants will be randomised to intervention and control groups.

A researcher will give the patients in the intervention group a Smileyscope Pty Ltd. headset to deliver the VR experience. The headset will be worn and used for the duration of the IUD insertion procedure, which will last for approximately 5-10 minutes. It is the only addition to the standard care given. The headset will display a 4 minute proprietary virtual reality relaxation video displaying nature content.

The control group will receive standard care.

Study participants and the doctors inserting the IUD will answer questions about the procedure to help answer our questions about the usefulness of VR in this setting. If the VR intervention is discontinued during the IUD insertion procedure, this information, the reason and any adverse effects suffered will also be recorded.
Intervention code [1] 322393 0
Treatment: Devices
Comparator / control treatment
Patients will be consented and randomised to either treatment or control groups. The control group will provide consent, receive standard care during the IUD insertion process (nil analgesia, having an awake IUD insertion in the outpatient setting) and complete a patient questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 329838 0
Subjective patient-reported pain on the 100mm Visual Analogue Scale.
Timepoint [1] 329838 0
Once during IUD insertion (primary timepoint) and once 10minutes following IUD insertion.
Secondary outcome [1] 404017 0
Patient-reported anxiety on 100mm visual analogue scale.
Timepoint [1] 404017 0
Immediately prior to commencing the procedure and once during IUD insertion.
Secondary outcome [2] 404018 0
Difficulty of IUD insertion measured by the number of insertion attempts
Timepoint [2] 404018 0
Immediately following IUD insertion assessed by accessing patient electronic medical record
Secondary outcome [3] 404019 0
Patient reported satisfaction ƒollowing completion of IUD insertion as determined by binary yes/no question.
Timepoint [3] 404019 0
10 minutes following completion of procedure.
Secondary outcome [4] 404899 0
Time required for insertion
Timepoint [4] 404899 0
Immediately following IUD insertion assessed by measuring length of procedure in minutes.
Secondary outcome [5] 404900 0
Proceduralist satisfaction.
Timepoint [5] 404900 0
Immediately following IUD insertion assessed by 5-point Likert scale

Eligibility
Key inclusion criteria
- Aged 18 years and over
- Requiring IUD insertion
- Able and willing to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients with contraindications to IUD insertion
- Patients with a history of epilepsy / vestibular disorders or other contraindications to VR use
- Patients who have taken pain relief prior to the procedure
- Inability to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used. Sequential opaque envelopes will contain the group to which the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) using a one-to-one ratio. Randomisation will be stratified by study setting. This will ensure an approximately equal allocation to each group within each site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations:
Visual analogue scale (VAS) is a well-accepted scoring system of pain, with differences of 10mm considered clinically significant from previous studies. For our power calculation we assumed an equal standard deviation of 14mm in VAS pain scores between groups based on previous studies of VAS pain scores in women with chronic pelvic pain. To achieve 80% of detecting a 10mm difference between groups with a type 1 error rate of 0.05, we required a sample size of 31 in each group. Accounting for a compliance rate of 90% we aimed for a sample size of 70 participants (35 in each group).

Statistical methods:
Continuous data will be summarised descriptively by mean, standard deviation, median etc. as appropriate. Enumerations and percentages will be presented for categorical data.
Comparisons in pain scores with and without VR use will be analysed using two-tailed t-tests.
Categorical data will be examined using Fisher’s exact test, and continuous data will be examined using t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
1/02/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21302 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 21303 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 36174 0
3168 - Clayton
Recruitment postcode(s) [2] 36175 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 310237 0
Commercial sector/Industry
Name [1] 310237 0
Smileyscope pty ltd
Country [1] 310237 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd, Clayton, VIC 3168.
Country
Australia
Secondary sponsor category [1] 311468 0
None
Name [1] 311468 0
Address [1] 311468 0
Country [1] 311468 0
Other collaborator category [1] 282085 0
Commercial sector/Industry
Name [1] 282085 0
Smileyscope pty ltd.
Address [1] 282085 0
Level 1, 333 Exhibition Street, Melbourne, VIC, 3000.
Country [1] 282085 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309916 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 309916 0
Ethics committee country [1] 309916 0
Australia
Date submitted for ethics approval [1] 309916 0
20/10/2021
Approval date [1] 309916 0
Ethics approval number [1] 309916 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115822 0
Dr Chloe Higgins
Address 115822 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 115822 0
Australia
Phone 115822 0
+61 3 9594 4611
Fax 115822 0
Email 115822 0
[email protected]
Contact person for public queries
Name 115823 0
Chloe Higgins
Address 115823 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 115823 0
Australia
Phone 115823 0
+61 3 9594 6666
Fax 115823 0
Email 115823 0
[email protected]
Contact person for scientific queries
Name 115824 0
Chloe Higgins
Address 115824 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 115824 0
Australia
Phone 115824 0
+61 3 9594 6666
Fax 115824 0
Email 115824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain patient confidentiality in a sensitive setting with a small study population that could therefore easily be identified.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.