Effect of the Format of a Video Game on Children's Experience During Venipuncture
Primary Purpose
Pain, Procedural
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Venipuncture
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Procedural focused on measuring Hypnosis, Virtual Reality, Behavioral intervention, Venipuncture
Eligibility Criteria
Inclusion Criteria:
- Children 5-12 undergoing a venipuncture as part of the Corona Immunitas Covid serology study
Exclusion Criteria:
- Parents prefer their child not to use screens
- Known or suspected light-sensitive epilepsy
- Moderate or severe intellectual disability
- Physical factors preventing placement of the VR headset (e.g.: wound on the face, etc.)
- Inability to understand or follow the procedures of the study due to a language barrie
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video game in Virtual reality
Video game on a tablet
Arm Description
The study subject will be playing a video game during the venipuncture, in virtual reality
The study subject will be playing a video game during the venipuncture, on a tablet
Outcomes
Primary Outcome Measures
Child rating of maximum pain
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Child rating of time spent thinking about pain
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Child rating of anxiety
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
"Fun" rating
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Parental rating of satisfaction
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Secondary Outcome Measures
Child rating of venipuncture unpleasantness
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Heart rate change during the venipuncture compared to the start of the procedure
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Number of persons required for physical and pharmacological restraint of children during these procedures
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Feeling of immersion into the game
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Parental anxiety
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Healthcare worker rating of satisfaction
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Full Information
NCT ID
NCT05065307
First Posted
August 13, 2021
Last Updated
November 8, 2022
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT05065307
Brief Title
Effect of the Format of a Video Game on Children's Experience During Venipuncture
Official Title
Effect of the Format of a Video Game on Children's Experience During Venipuncture
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
July 3, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
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
Anxiolysis and analgesia are of paramount importance when conducting medical procedures, particularly in children. Nonpharmacologic techniques such as distraction and hypnosis improve the patient experience when used in the correct setting and may reduce the need for medications and pharmacological sedation. Virtual reality immersion is a novel approach to anxiolysis and analgesia but the content (i.e. games) available on the market are limited in their appropriateness for age, and the lack of specific design for medical procedures. VRelief, designed using a multidisciplinary team of clinicians, hypnosis practitioners, psychologists and computer scientists specializing in the Multimodal Modelling of Emotion & Feeling may present a safe and superior alternative to a similar game presented in a video tablet format, in mitigating procedural anxiety and pain and improving the patient experience during venipuncture.
Detailed Description
Pain and anxiety experienced in the acute care setting remain a major global problem, resulting in high costs for those involved as well as for health care institutions. Pain and anxiety management techniques affect the quality of the care experienced by patients, relatives, and healthcare workers. Pharmacological procedures remain the most widely used approach, although they have important limitations, such as potential for adverse effects and dosing errors, especially in the most vulnerable populations such as young children. Non-pharmacological approaches to analgesia and anxiolysis have been explored, among which placebo, expectant, distraction, positive induction, reward, self-regulation, relaxation and hypnosis. Unfortunately, translational applications have been only partially successful, due to the limited and variable effectiveness of each approach, which often requires active and continuous patient cooperation. Hypnosis is an effective but incomplete approach that requires the presence of a specialist and can only be practiced from a certain age.
Virtual Reality (VR) is a promising technology that combines all of these methods above into an immersive and engaging tool for pain and anxiety relief that could equal or exceed the effectiveness of other existing non-pharmacological techniques. In addition, it is relatively inexpensive and provides a relevant alternative when hypnosis practitioners are not available.
The virtual reality contents (hereon ''games'') available on the market are varied. However, these tools are mainly based on distraction and often do not take into account the therapeutic communication and hypnosis principles proven useful in managing anxious children, as well as other psychological factors facilitating, for example, the "empowerment" of patients. Moreover, the quality of immersion in a virtual environment is essential for its effectiveness, and the tools currently available remain limited in this respect (mini-games, 360-degree video). Moreover, these tools have little external control and even fewer intelligent mechanisms to adapt content to the patient experience.
The investigators developed a prototype VR tool, which, unlike tools from other clinical studies of virtual reality, implemented a narration integrating several properties of hypnosis induction (in particular relaxation and regulation) with a gameplay designed to induce distraction and empowerment. The game was developed with the objective of engaging the child in an environment where he or she is first familiarized and reassured, then engaged in the missions of the game, and finally rewarded, all with the intent of decreasing anxiety and pain during a procedure. The investigators have carefully adapted the initial versions of this VR scenario to young, hospitalized children (starting from the age of 5 years of age) undergoing painful and anxiogenic procedures such as venipuncture. This population is ideal for our needs because they are often resistant to other non-pharmacological techniques (hypnosis susceptibility peaks between 8 and 12 years and, at the same time, have a good knowledge of artificial environments and computer games. A pilot study conducted in our department showed that children who played the VR game rated their pain and anxiety less high than children who received standard of care, during venipuncture. Venipuncture is some of the most common procedures in pediatric emergency departments and one of the most common sources of unrelieved pain and anxiety in hospitalized children.
To date, no study has attempted to isolate the added value of VR by comparing it with a similar game offered in a format such as a video tablet (ie.g.: iPad, etc.).
When used in a correct subset of patients (excluding patients with light-sensitive epilepsy), there are no risks anticipated aside from potential mild nausea or dizziness, which is rarely described in children using virtual reality, which would make this study a risk category A study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
Keywords
Hypnosis, Virtual Reality, Behavioral intervention, Venipuncture
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video game in Virtual reality
Arm Type
Experimental
Arm Description
The study subject will be playing a video game during the venipuncture, in virtual reality
Arm Title
Video game on a tablet
Arm Type
Active Comparator
Arm Description
The study subject will be playing a video game during the venipuncture, on a tablet
Intervention Type
Diagnostic Test
Intervention Name(s)
Venipuncture
Intervention Description
Diagnostic venipuncture
Primary Outcome Measure Information:
Title
Child rating of maximum pain
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Child rating of time spent thinking about pain
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Child rating of anxiety
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
"Fun" rating
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Parental rating of satisfaction
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Secondary Outcome Measure Information:
Title
Child rating of venipuncture unpleasantness
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Heart rate change during the venipuncture compared to the start of the procedure
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
baseline, during the intervention, immediately after the intervention and 5 minutes later
Title
Number of persons required for physical and pharmacological restraint of children during these procedures
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Feeling of immersion into the game
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Parental anxiety
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
Title
Healthcare worker rating of satisfaction
Description
Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)
Time Frame
during venipuncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Children 5-12 undergoing a venipuncture as part of the Corona Immunitas Covid serology study
Exclusion Criteria:
Parents prefer their child not to use screens
Known or suspected light-sensitive epilepsy
Moderate or severe intellectual disability
Physical factors preventing placement of the VR headset (e.g.: wound on the face, etc.)
Inability to understand or follow the procedures of the study due to a language barrie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril Sahyoun, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
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Effect of the Format of a Video Game on Children's Experience During Venipuncture
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