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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR | Experimental | The intervention group will receive VR support upon the standard of care during the procedure. |
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| Control | No Intervention | The control group will have standard care without the VR support. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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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 |