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Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology. (VIRTUOSO)

Primary Purpose

Hematologic Malignancy, Hematologic Non Malignancy, Solid Tumor, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual distraction and pain prevention techniques.
Virtual reality
Choice between usual distraction or virtual reality
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy focused on measuring Pediatric, Pediatric oncology, Pain, Virtual reality, Nurse

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Quantitative component:

  • Child aged 7 to 18 years
  • Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management.
  • Child who has already experienced a potentially painful care procedure before entry the study
  • Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care.
  • Child with consent.
  • Child whose parental authority holders have given their consent to participate to the study.

Qualitative component:

  • Professional who used both care-induced pain prevention techniques and agreed to be interviewed.
  • A parent or guardian.

Exclusion Criteria:

  • Child who refuse to use this distraction technique (VR).
  • Child who refuse to not use MEOPA during VR.
  • Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion
  • Child who does not speak French and whose parents do not speak French

Sites / Locations

  • Nantes CHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard treatment then virtual reality then choice between the two

Arm Description

Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement. For the 3rd treatment, the child will choose his/her favorite technique.

Outcomes

Primary Outcome Measures

Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the second care using virtual reality
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.

Secondary Outcome Measures

Percentage of children who choose VR in the 3rd care
Patient preference between VR and usual pain prevention technique for the same care. The difference between the pain level measured on a VAS with the use of VR and the pain level with the usual technique. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Patient questionnaire
Analysis of the answers to the patient questionnaire after treatment n°3. Description of the reasons for selecting the preferred technique.
Side effects to the use of VR
Record of side effects reported in the e-CRF. Description of the potential side effects to the use of VR in care.
Ethnographic approach to caregivers' experiences after using the VR headset.
Direct observation of the care unit. Understand the obstacles and levers for professionals to implement a new pain prevention device during care.
parent questionnaire.
Analysis of the responses to the parent questionnaire. Understand parents' experience of care when implementing a new pain prevention device during care.
Thematic analysis of the verbatim collected during the semi-directive interviews with the parents after Care 3
Understand the social representations of parents and children regarding the use of a virtual reality device.

Full Information

First Posted
August 25, 2021
Last Updated
August 23, 2023
Sponsor
Nantes University Hospital
Collaborators
For Ever Fabien
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1. Study Identification

Unique Protocol Identification Number
NCT05042479
Brief Title
Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
Acronym
VIRTUOSO
Official Title
Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
July 11, 2024 (Anticipated)
Study Completion Date
July 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
For Ever Fabien

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences. During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc…) Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment. In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia. Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures. Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures. The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures. Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures. The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.
Detailed Description
VIRTUOSO is a study that aims to evaluate the impact of using a virtual reality headset to prevent care-induced pain in pediatric oncology. This study plans to include 34 patients. It is a single-center, non-inferiority, controlled, with cross-over study. Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd treatment, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age. For the 3rd treatment, the child will choose his/her favorite technique. The virtual reality headset is an Occulus Quest headset, composed of 2 integrated earphones. It is adapted to the environment and can be used sitting or standing. Usual pharmacological techniques for pain prevention will be maintained as per local practice. All concomitant treatments are authorized except the use of oxygen-nitrous oxide mixtures. The duration of this study is approximately 20 months. Inclusion will be for 10 months, patient follow-up for 6 months. Data analysis will be performed during 4 months. During each treatment, if the child wishes to stop VR, the helmet will be removed and the usual techniques will be offered. After each procedure, a self-assessment of the pain will be done immediately, using VAS. At the end of the third treatment, a short questionnaire will be proposed to the child in order to collect the reasons for his choice. Another questionnaire will also be proposed to the parent present during the care. A qualitative component will explore the social representations of the parents. A range of semi-directive interviews will be conducted with 6 families by a trained professional under the supervision of the methodologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Hematologic Non Malignancy, Solid Tumor, Childhood, Child, Only
Keywords
Pediatric, Pediatric oncology, Pain, Virtual reality, Nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment then virtual reality then choice between the two
Arm Type
Experimental
Arm Description
Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement. For the 3rd treatment, the child will choose his/her favorite technique.
Intervention Type
Other
Intervention Name(s)
Usual distraction and pain prevention techniques.
Intervention Description
For the first painful procedure, the child will benefit usual distraction and pain prevention techniques.Pain prevention and management techniques commonly used in the conduct of care: Application of a patch or anaesthetic cream 1 hour before the treatment Vigilant sedation using a premedication for lumbar punctures: Midazolam /Nalbuphine/Hydroxyzine/Morphine. Apart from care using VR, MEOPA can be given to the child for all assessed care on prescription. Apart from care using VR, the usual distraction techniques are left to the patient's choice (electronic tablet, smartphone, games, songs...) The presence of the parents
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
For the 2nd painful procedure, the child will use a VR (virtual reality) headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
Intervention Type
Other
Intervention Name(s)
Choice between usual distraction or virtual reality
Intervention Description
For the 3rd painful procedure, the child will choose his/her favorite technique between : Usual distraction and pain prevention techniques or virtual reality
Primary Outcome Measure Information:
Title
Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
Description
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Time Frame
Immediately after the first care.
Title
Pain level measured by VAS (self-evaluation) during the second care using virtual reality
Description
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Time Frame
Immediately after the second care .
Title
Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment
Description
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Time Frame
Immediately after the third care .
Secondary Outcome Measure Information:
Title
Percentage of children who choose VR in the 3rd care
Description
Patient preference between VR and usual pain prevention technique for the same care. The difference between the pain level measured on a VAS with the use of VR and the pain level with the usual technique. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Time Frame
Immediately after the 3rd intervention.
Title
Patient questionnaire
Description
Analysis of the answers to the patient questionnaire after treatment n°3. Description of the reasons for selecting the preferred technique.
Time Frame
Immediately after the 3rd intervention.
Title
Side effects to the use of VR
Description
Record of side effects reported in the e-CRF. Description of the potential side effects to the use of VR in care.
Time Frame
During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.
Title
Ethnographic approach to caregivers' experiences after using the VR headset.
Description
Direct observation of the care unit. Understand the obstacles and levers for professionals to implement a new pain prevention device during care.
Time Frame
Through study completion - up to 20 months.
Title
parent questionnaire.
Description
Analysis of the responses to the parent questionnaire. Understand parents' experience of care when implementing a new pain prevention device during care.
Time Frame
Immediately after the 3rd intervention.
Title
Thematic analysis of the verbatim collected during the semi-directive interviews with the parents after Care 3
Description
Understand the social representations of parents and children regarding the use of a virtual reality device.
Time Frame
Immediately after the 3rd intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Quantitative component: Child aged 7 to 18 years Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management. Child who has already experienced a potentially painful care procedure before entry the study Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care. Child with consent. Child whose parental authority holders have given their consent to participate to the study. Qualitative component: Professional who used both care-induced pain prevention techniques and agreed to be interviewed. A parent or guardian. Exclusion Criteria: Child who refuse to use this distraction technique (VR). Child who refuse to not use MEOPA during VR. Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion Child who does not speak French and whose parents do not speak French
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas JEZEQUEL
Phone
(0)2.76.64.38.63
Ext
+33
Email
thomas.jezequel@chu-nantes.fr
Facility Information:
Facility Name
Nantes CHU
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Jezequel
Email
thomas.jezequel@chu-nantes.fr

12. IPD Sharing Statement

Learn more about this trial

Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.

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