IUDREAVISTNCT04539899
Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion
A study testing VR+ in people with IUD, run by Rennes University Hospital at 2 sites in France.
Trial summary
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUD
- What is being tested?
- VR+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Sep 2020to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adult
- Who has benefited from contraceptive counseling
- The choice of an IUD (hormonal or copper)
- Having signed a written informed consent.
- Affiliation to a social security scheme.
Who cannot join
- Pre-existing dizzying sensations
- Severe facial wounds
- History of epilepsy
- Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.
Observational, prospective, randomized, open-label, monocentric study.
- Conditions
- IUD
- Being tested
- VR+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR+Other
Use of a virtual reality helmet during IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| VR+ | Experimental | For patients in the experimental group, using the virtual reality helmet, the caregiver will position the helmet on the patient when she is placed on the gynecological examination table. He or she will make sure that the patient can see and hear the current sequence. The caregiver can then proceed with the different steps of the IUD insertion. Once the procedure is completed, the caregiver will indicate to the patient that she can remove the headphones. Receives: Other: VR+ |
| VR- | No intervention | For patients in the control group, without a helmet, the course of the consultation will not be modified. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS during IUD insertion
The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful)
Measured: 20 minutes
Secondary outcomes (2)
Stress level difference with virtual reality
Difference of stress between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = non stress and 10 = maximum of stress
Measured: 20 minutes
Satisfaction level difference with virtual reality
Difference of satisfaction between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = not satisfied at all and 10 = totally satisfied
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start23 Sep 2020
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539899
- Sponsor's protocol ID
- 35RC20_8886_REAVIST
- Acronym
- REAVIST
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST
- ClinicalTrials.gov ID
- NCT04539899
- Acronym / sponsor ID
- REAVIST / 35RC20_8886_REAVIST
- Conditions
- IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.
Observational, prospective, randomized, open-label, monocentric study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| VR+ | Experimental | Other: VR+For patients in the experimental group, using the virtual reality helmet, the caregiver will position the helmet on the patient when she is placed on the gynecological examination table. He or she will make sure that the patient can see and hear the current sequence. The caregiver can then proceed with the different steps of the IUD insertion. Once the procedure is completed, the caregiver will indicate to the patient that she can remove the headphones. |
| VR- | No intervention | –For patients in the control group, without a helmet, the course of the consultation will not be modified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female adult
- Who has benefited from contraceptive counseling
- The choice of an IUD (hormonal or copper)
- Having signed a written informed consent.
- Affiliation to a social security scheme.
Key exclusion criteria (4 listed)
- Pre-existing dizzying sensations
- Severe facial wounds
- History of epilepsy
- Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR+Use of a virtual reality helmet during IUD insertion | Other | VR+ |
Primary outcome
NRS during IUD insertion
Time frame: 20 minutes
The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful)
2 secondary outcomes
Stress level difference with virtual reality
Time frame: 20 minutes
Satisfaction level difference with virtual reality
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR+ in people with IUD, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS during IUD insertion (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.