Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia (REVCCI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Implanted Venous Access Device
• Intervention / Treatment: Device: REV : local anesthesia and virtual reality; Device: MUS : local anesthesia and music therapy

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 Type: Interventional
• Enrollment (Estimated): 127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelmalek GHIMOUZ, Dr.; Phone Number: 0156245765; Email: abdelmalek.ghimouz@curie.fr
• Study Contact Backup: Name: Cyrine EZZILI, PhD; Phone Number: 0156245765; Email: drci.promotion@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie
  • Saint-cloud, France, 92210
    • Institut Curie
  • Villejuif, France, 94805
    • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient aged between 18 and 85 years.
2. Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
3. Absence of anxiolytic premedication.
4. Patient affiliated to social insurance.
5. Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
6. Signed informed consent form.

Exclusion Criteria:

1. Patient already participated to this study.
2. Patient deprived of liberty or under legal representative or under curatorship.
3. Psychiatric disease enabling communication.
4. Deafness or visual impairement.
5. Patient under beta-blockers medication.
6. Chronic pain present and not equilibrated before the measured procedure as > 3 by the NRS.
7. Tracheotomy.
8. Low cervical tumor, or bilateral low cervical adenopathies.
9. Compression or jugular stenosis (uni or bilateral).
10. Jugular or subclavian thrombosis.
11. Patient under anticoagulants medication or having hesmostasis troubles.
12. Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.
13. Patients not speaking french.
14. Pregnant and breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REV : local anesthesia and virtual reality; Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia	Device: REV : local anesthesia and virtual reality; REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
Experimental: MUS : local anesthesia and music therapy; Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia	Device: MUS : local anesthesia and music therapy; MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
No Intervention: CONTROL : standard local anesthesia; Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 day
Global patient satisfaction of NRS and comparison between the 3 groups.	patient satisfaction of NRS	1 day
Pain NRS means felt during the procedure and comparison.	NRS means	1 day
Anxiety NRS means felt during the procedure and comparison.	NRS means	1 day

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Steven LE GOUILL, Pr., Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Estimated): March 16, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IC 2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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