IUD
Conditions
Keywords
Virtual Reality, IUD, Discomfort
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.
Interventions
DEVICEVirtual Reality
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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). |
| 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. |
Countries
Belgium
Outcome results
None listed