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

NCT ID: NCT04804735

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-08-16

Brief Summary

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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

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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

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Implanted Venous Access Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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REV : local anesthesia and virtual reality

Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Group Type EXPERIMENTAL

REV : local anesthesia and virtual reality

Intervention Type DEVICE

REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia

MUS : local anesthesia and music therapy

Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Group Type EXPERIMENTAL

MUS : local anesthesia and music therapy

Intervention Type DEVICE

MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia

CONTROL : standard local anesthesia

Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REV : local anesthesia and virtual reality

REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Intervention Type DEVICE

MUS : local anesthesia and music therapy

MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven LE GOUILL, Pr.

Role: STUDY_DIRECTOR

Institut Curie

Locations

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Institut Curie

Paris, , France

Site Status

Institut Curie

Saint-Cloud, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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IC 2020-03

Identifier Type: -

Identifier Source: org_study_id

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