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

Universitaire Ziekenhuizen KU Leuven200 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

200

Conditions

IUD

Interventions

Virtual RealityDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

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.

Time frame: At insertion

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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