NCT03418597

Brief Summary

The primary objective of this trial is to evaluate the benefit of the virtual reality technology in the pain management for patients having a radio-guided musculoskeletal biopsy indication

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

January 5, 2018

Last Update Submit

August 22, 2018

Conditions

Musculoskeletal Cancers

Keywords

Virtual realityRadio-guided biopsyPainAnxietyPatient's satisfaction

Outcome Measures

Primary Outcomes (1)

  • Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.

    The main outcome will be the pain level auto-evaluated by the patient using a numeric scale composed of 11 graduations (from 0 to 10)

    Day 0

Secondary Outcomes (5)

  • Evaluate in both arms, the pain linked to the biopsy procedure using a numeric scale graduated from 0 to 10.

    Day 1 (+/-2h) post biopsy

  • Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10

    Day 0

  • Evaluate the analgesics consumption in both arms

    through study completion, an average of 24 hours

  • Evaluate the global satisfaction of patients in both arms

    Day 0

  • Evaluate costs in both arms

    through study completion, an average of 24 hours

Study Arms (2)

Deep local anesthesia + Virtual reality

EXPERIMENTAL

Pre-medication procedures and lidocaïne injection are the same as in the current practice. During the intervention delay, the patient will also experience hypnosis through a virtual reality procedure .

Procedure: Deep local anesthesia + Virtual reality

Deep local anesthesia alone

ACTIVE COMPARATOR

The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne.

Procedure: Deep local anesthesia alone

Interventions

Deep local anesthesia + Virtual realityPROCEDURE

Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne). Patient will have a 3-D immersive experience, created using a visual and audio headset and a software labelled as medical device.

Deep local anesthesia + Virtual reality
Deep local anesthesia alonePROCEDURE

Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne).

Deep local anesthesia alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman, aged \>= 18 years at the day of consenting to the study (no upper limit)
  • Requiring a radio-guided biopsy of the musculoskeletal system,
  • Informed and signed consent,
  • Patient covered by a medical insurance.

You may not qualify if:

  • Deaf patient;
  • Visually-impaired patient;
  • Claustrophobic and/or aquaphobic patient;
  • Contraindication to a musculoskeletal biopsy, including to the premedication protocol and to the lidocaine;
  • Person deprived of liberty or placed under guardianship;
  • Absence of French language skills;
  • History of psychiatric disease such as paranoia, schizophrenia, manic-depressive psychosis, patient with a high risk of suicide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • BOUHAMAMA Amine, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

February 1, 2018

Study Start

January 31, 2018

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

FR(1)