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Completed

NCT Number: NCT04804735

Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

REV : local anesthesia and virtual reality

Device

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

MUS : local anesthesia and music therapy

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.

    Time frame: 1 day

    Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.

  2. 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

    NRS and responses to the closed questions

  3. Global patient satisfaction of NRS and comparison between the 3 groups.

    Time frame: 1 day

    patient satisfaction of NRS

  4. Pain NRS means felt during the procedure and comparison.

    Time frame: 1 day

    NRS means

  5. Anxiety NRS means felt during the procedure and comparison.

    Time frame: 1 day

    NRS means

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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

Acronym: REVCCI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.