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Clinical Trials/NCT05015790
NCT05015790
Unknown
Not Applicable

Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients

Poissy-Saint Germain Hospital1 site in 1 country120 target enrollmentFebruary 5, 2021
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Poissy-Saint Germain Hospital
Enrollment
120
Locations
1
Primary Endpoint
The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.
Last Updated
4 years ago

Overview

Brief Summary

To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

Detailed Description

The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy. The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient. Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre. The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.

Registry
clinicaltrials.gov
Start Date
February 5, 2021
End Date
June 5, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Poissy-Saint Germain Hospital
Responsible Party
Principal Investigator
Principal Investigator

Valérie LOIZEAU

paramedical research coordination

Poissy-Saint Germain Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patient over 18 years of age
  • Patient suffering from a cancerous pathology
  • Patient taken care of for the installation of the ICH

Exclusion Criteria

  • Patient does not speak and understand French
  • Patient who has had a previous ICH installation
  • Patient with cognitive impairment
  • Patient with pain perception disorder

Outcomes

Primary Outcomes

The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.

Time Frame: one year

At the same the main evaluation criterion is a visual analogue scale (VAS) allowing a self-evaluation of the pain felt by the patient during the surgical intervention. The patient will rate their pain, on a scale from 0 for no pain to 10 for very severe pain. the data will be recorded at the time of the patient's installation, during the venipuncture and at the creation of the pocket.

Secondary Outcomes

  • The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.(one year)

Study Sites (1)

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