Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial

Study Overview
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Brief Summary
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Aim of this study is to evaluate the effect of VR on the patients overall experience during the IUD insertion procedure.

Detailed Description
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A single center, investigator initiated randomized controlled clinical trial. 200 women to be recruited, 100 in the intervention group and 100 in the control group. The control group will receive the usual treatment (without specific pain management) and the intervention group will receive the usual treatment with VR support. Endpoints are: Objective: successful procedure, need for general anesthesia, presence of syncope and/or vomitus Subjective: Pain, procedural cooperation, the degree of difficulty encountered by the physician in performing the treatment, ability to complete VR procedure.

Official Title
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Clinical Effectiveness of Virtual Reality Simulation in Reducing Discomfort, Anxiety and Pain During Intrauterine Device Insertion: A Randomized Clinical Trial

Conditions
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IUD

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women who are seeking hormonal intrauterine contraception will be offered participation in the trial if they are 18 years of age or older (minors can be included if a guardians permission has been obtained), are not pregnant, and are willing to follow-up after 6 weeks for a sonographic IUD check. Exclusion Criteria: Epilepsy Auditive or visual disabilities Invalidating claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR<br>The intervention group will receive VR support upon the standard of care during the procedure. | Device: Virtual Reality<br>* The VR goggles have a 2560×1440 5.5 (538ppi) fast-switching LCD screen with standard 60Hz refresh, overclocked 72Hz refresh, running Android 7.1.2 Nougat with a Quad-core Qualcomm Snapdragon 821 (two 2.3GHz Kryo HP cores and two 2.15GHz Kryo cores). Adreno 530 as GPU. It is 190 x 105 x 115 mm en weighs 470 g (1.04 lbs). The goggles have built-in speakers, a controller, proximity sensor, 3DOF sensors (both headset and controller). Any pre-procedural self-administration of pain medication will be recorded. Trained staff-members or senior residents will do all IUD insertions, according to the local protocol.<br>|
| No Intervention: Control<br>The control group will have standard care without the VR support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients overall experience of IUD insertion | Primary outcome of this study is the patients overall experience of the insertion / replacement of a hormonal IUD. This will be measured by using a Visual Analog Scale (0-100mm, continuous scale). The left extreme of this scale represents no distress, and the right extreme represents unbearable distress. | At insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during insertion | Assessment of the effect of VR support on pain by the Numeric Pain Rating Scale (0-100), the higher the score, the more pain. | At insertion and 6 weeks later | 
| Discomfort | Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a Visual analogue scale (0-100mm, continuous scale). | At insertion and 6 weeks later | 
| Degree of difficulty encountered by the physician | Assessment of the degree of difficulty encountered by the physician in performing the treatment, by means of a 5-point Likert scale (1=very easy, 2=easy, 3=neutral, 4=difficult, 5=very difficult). | At insertion | 
| Success rate of the procedure | Assessment of the success of the procedure, by recording the correct/ incorrect position of the IUD (including expulsions and perforations) and possible need to repeat the procedure under general anesthesia. Correct placement is defined as the presence of the IUD completely within the uterine cavity visualized by ultrasound. | At insertion and 6 weeks later | 
| Patient satisfaction on the longer term | Assessment of the patient satisfaction on the longer term by asking the patient whether knowing now about the discomfort, they would repeat the procedure or recommend it to a friend. This will be assessed by using a 5-point Likert scale (1=Definitely, 2= might, 3= uncertain, 4= probably not, 5= definitely not). | 6 weeks after insertion | 
| Side events | Record of the known side events of this intervention (syncope, vomitus). | At insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, IUD, Discomfort