Implanted Venous Access DeviceREVCCINCT04804735
Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia
A study testing REV : local anesthesia and virtual reality and MUS : local anesthesia and music therapy in people with Implanted Venous Access Device, run by Institut Curie at 3 sites in France.
Trial summary
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Implanted Venous Access Device
- What is being tested?
- REV : local anesthesia and virtual reality and MUS : local anesthesia and music therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Dec 2022to 16 Aug 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 18 and 85 years.
- Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
- Absence of anxiolytic premedication.
- Patient affiliated to social insurance.
- Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
- Signed informed consent form.
Who cannot join
- Patient already participated to this study.
- Patient deprived of liberty or under legal representative or under curatorship.
- Psychiatric disease enabling communication.
- Deafness or visual impairement.
- Patient under beta-blockers medication.
- Chronic pain present and not equilibrated before the measured procedure as > 3 by the NRS.
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- Tracheotomy.
- Low cervical tumor, or bilateral low cervical adenopathies.
- Compression or jugular stenosis (uni or bilateral).
- Jugular or subclavian thrombosis.
- Patient under anticoagulants medication or having hesmostasis troubles.
- Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.
- Patients not speaking french.
- Pregnant and breastfeeding women.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Curie
Paris, 75005
Institut Curie
Saint-Cloud, 92210
Gustave Roussy
Villejuif, 94805
About this study
Official title: Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
Read the detailed description
Evaluate the efficacy of virtual reality and music therapy on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
- Conditions
- Implanted Venous Access Device
- Being tested
- REV : local anesthesia and virtual reality, MUS : local anesthesia and music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REV : local anesthesia and virtual realityDevice
REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
MUS : local anesthesia and music therapyDevice
MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| REV : local anesthesia and virtual reality | Experimental | Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia Receives: Device: REV : local anesthesia and virtual reality |
| MUS : local anesthesia and music therapy | Experimental | Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia Receives: Device: MUS : local anesthesia and music therapy |
| CONTROL : standard local anesthesia | No intervention | Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean of pain felt during the whole IVAD procedure
pain means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no pain and 10 the maximum pain feeling.
Measured: 1 day
mean of anxiety felt during the whole IVAD procedure
Anxiety means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no anxiety and 10 the maximum anxiety feeling.
Measured: 1 day
Secondary outcomes (5)
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Measured: 1 day
Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.
NRS and responses to the closed questions
Measured: 1 day
Global patient satisfaction of NRS and comparison between the 3 groups.
patient satisfaction of NRS
Measured: 1 day
Pain NRS means felt during the procedure and comparison.
NRS means
Measured: 1 day
Anxiety NRS means felt during the procedure and comparison.
NRS means
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start6 Dec 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implanted Venous Access DeviceStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven LE GOUILL, Pr., Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804735
- Sponsor's protocol ID
- IC 2020-03
- Acronym
- REVCCI
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Ghimouz A, Dureau S, Carton M, Gomola A, Fadel Z, Thuong KK, Muret J. The effects of music and virtual reality on pain and anxiety during central venous port implantation: a randomised clinical trial. Sci Rep. 2026 Mar 7;16(1):12514. doi: 10.1038/s41598-026-42184-w.
PubMed 41794895
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT04804735
- Acronym / sponsor ID
- REVCCI / IC 2020-03
- Conditions
- Implanted Venous Access Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 18 Mar 2021 (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.
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
Detailed description
Evaluate the efficacy of virtual reality and music therapy on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| REV : local anesthesia and virtual reality | Experimental | Device: REV : local anesthesia and virtual realityUse of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
| MUS : local anesthesia and music therapy | Experimental | Device: MUS : local anesthesia and music therapyUse of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
| CONTROL : standard local anesthesia | No intervention | –Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged between 18 and 85 years.
- Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
- Absence of anxiolytic premedication.
- Patient affiliated to social insurance.
- Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
Key exclusion criteria (14 listed)
- Patient already participated to this study.
- Patient deprived of liberty or under legal representative or under curatorship.
- Psychiatric disease enabling communication.
- Deafness or visual impairement.
- Patient under beta-blockers medication.
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 |
|---|---|---|
| REV : local anesthesia and virtual realityREV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia | Device | REV : local anesthesia and virtual reality |
| MUS : local anesthesia and music therapyMUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia | Device | MUS : local anesthesia and music therapy |
Primary outcome
mean of pain felt during the whole IVAD procedure
Time frame: 1 day
pain means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no pain and 10 the maximum pain feeling.
mean of anxiety felt during the whole IVAD procedure
Time frame: 1 day
Anxiety means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no anxiety and 10 the maximum anxiety feeling.
5 secondary outcomes
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Time frame: 1 day
Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.
Time frame: 1 day
Global patient satisfaction of NRS and comparison between the 3 groups.
Time frame: 1 day
Pain NRS means felt during the procedure and comparison.
Time frame: 1 day
Anxiety NRS means felt during the procedure and comparison.
Time frame: 1 day
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 Jul 2025.
- Derived from this study: PubMed 41794895Ghimouz A, Dureau S, Carton M, Gomola A, Fadel Z, Thuong KK, Muret J. The effects of music and virtual reality on pain and anxiety during central venous port implantation: a randomised clinical trial. Sci Rep. 2026 Mar 7;16(1):12514. doi: 10.1038/s41598-026-42184-w.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Implanted Venous Access Device
Recruiting
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Virtual Reality, Children and Adolescents
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.
Steven LE GOUILL, Pr. study director
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REV : local anesthesia and virtual reality and MUS : local anesthesia and music therapy in people with Implanted Venous Access Device, run by Institut Curie at 3 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 6 inclusion and 14 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
mean of pain felt during the whole IVAD procedure (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804735, which also lists 1 linked publication.
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 Jul 2025.