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Completed

NCT Number: NCT04389021

Virtual Reality Simulation for 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.

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Key information

Conditions

IUD

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patients overall experience of IUD insertion

    Time frame: 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 outcomes

  1. Pain during insertion

    Time frame: 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.

  2. Discomfort

    Time frame: 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).

  3. Degree of difficulty encountered by the physician

    Time frame: 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).

  4. Success rate of the procedure

    Time frame: 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.

  5. Patient satisfaction on the longer term

    Time frame: 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).

  6. Side events

    Time frame: At insertion

    Record of the known side events of this intervention (syncope, vomitus).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: VR-IUD

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 15, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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