Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy (REAVA)
Primary Purpose
Breast Cancer, Pelvic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality software
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
- Patient ≥ 18 years old,
- Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
- Patient with social security coverage.
Exclusion Criteria:
- Metastatic patients
- Patients with previous radiotherapy
- Patients with a diagnosis of hearing impairment
- Patients with major cognitive disorders (such as dementia)
- Psychiatric pathology such as schizophrenia
- Patients with epilepsy or hypersensitivity to flashing lights
- Patient with a pacemaker, hearing aid or defibrillator
- Claustrophobic patients
- Patients sensitive to motion sickness
- Patients who are visually impaired or blind
- Patients with migraine
- Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
- Patients under guardianship, curators or deprived of liberty
- Non French speaking patient
- Illiterate patient
- Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
- Pregnant or breastfeeding patient
Sites / Locations
- CHD VendéeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality
Normal care
Arm Description
Virtual reality session performed before the planning CT scan
Normal care without intervention
Outcomes
Primary Outcome Measures
Evaluating the anxiety of the patient benefiting from a virtual reality session versus normal care management
Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05269186
First Posted
February 25, 2022
Last Updated
June 15, 2023
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT05269186
Brief Title
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
Acronym
REAVA
Official Title
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.
A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.
Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.
This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.
The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.
Virtual reality software seems to be a good alternative that requires fewer human resources.
The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Pelvic Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Virtual reality session performed before the planning CT scan
Arm Title
Normal care
Arm Type
No Intervention
Arm Description
Normal care without intervention
Intervention Type
Device
Intervention Name(s)
Virtual reality software
Intervention Description
The patient will undergo a 20-minute virtual reality session before the planning CT scan
Primary Outcome Measure Information:
Title
Evaluating the anxiety of the patient benefiting from a virtual reality session versus normal care management
Description
Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Time Frame
10 minute before the planning CT scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
Patient ≥ 18 years old,
Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
Patient with social security coverage.
Exclusion Criteria:
Metastatic patients
Patients with previous radiotherapy
Patients with a diagnosis of hearing impairment
Patients with major cognitive disorders (such as dementia)
Psychiatric pathology such as schizophrenia
Patients with epilepsy or hypersensitivity to flashing lights
Patient with a pacemaker, hearing aid or defibrillator
Claustrophobic patients
Patients sensitive to motion sickness
Patients who are visually impaired or blind
Patients with migraine
Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
Patients under guardianship, curators or deprived of liberty
Non French speaking patient
Illiterate patient
Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
Pregnant or breastfeeding patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Dorion
Phone
251446380
Ext
+33
Email
agnes.dorion@ght85.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric ALANET
Organizational Affiliation
cedric.alanet@ght85.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric ALANET
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
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