Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial (VR-IUD)

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

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

Study Overview

• Status: Completed
• Conditions: IUD
• Intervention / Treatment: Device: Virtual Reality

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR; The intervention group will receive VR support upon the standard of care during the procedure.	Device: Virtual 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.
No Intervention: Control; The control group will have standard care without the VR support.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Virtual Reality; Discomfort; IUD
• Other Study ID Numbers: S63124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No