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

Not Applicable

Active, not recruiting

• Conditions: Implanted Venous Access Device

• Registration Number: NCT04804735
• Lead Sponsor: Institut Curie

Brief Summary

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 Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2022-12-06
• Primary Completion: 2023-08-16
• Status Verified: 2023-09
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Study Completion: 2024-03-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 127

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mean of pain felt during the whole IVAD procedure	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	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.

Secondary Outcome Measures

Name	Time	Method
Pain NRS means felt during the procedure and comparison.	1 day	NRS means
Global patient satisfaction of NRS and comparison between the 3 groups.	1 day	patient satisfaction of NRS
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.	1 day	Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.	1 day	NRS and responses to the closed questions
Anxiety NRS means felt during the procedure and comparison.	1 day	NRS means

Trial Locations

Locations (2)

Gustave Roussy; 🇫🇷 Villejuif, France

Institut Curie; 🇫🇷 Saint-cloud, France