Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial
- Conditions
- IUD
- Interventions
- Device: Virtual Reality
- Registration Number
- NCT04389021
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Aim of this study is to evaluate the effect of VR on the patients overall experience during the IUD insertion procedure.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
- 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.
- Epilepsy
- Auditive or visual disabilities
- Invalidating claustrophobia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR Virtual Reality The intervention group will receive VR support upon the standard of care during the procedure.
- Primary Outcome Measures
Name Time Method Patients overall experience of IUD insertion At 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.
- Secondary Outcome Measures
Name Time Method Pain during insertion At insertion and 6 weeks later Assessment of the effect of VR support on pain by the Numeric Pain Rating Scale (0-100), the higher the score, the more pain.
Discomfort At insertion and 6 weeks later Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a Visual analogue scale (0-100mm, continuous scale).
Degree of difficulty encountered by the physician At insertion 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).
Success rate of the procedure At insertion and 6 weeks later 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.
Patient satisfaction on the longer term 6 weeks after insertion 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).
Side events At insertion Record of the known side events of this intervention (syncope, vomitus).
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium