Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain
Primary Purpose
Chronic Non-specific Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Semi-structured interview
Sponsored by
About this trial
This is an interventional other trial for Chronic Non-specific Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Adults (over 18 years), men or women, living in Belgium
- Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain)
- To speak fluent French and to be able to provide informed consent to take part in an interview
- To be able to take part in a semi-structured interview
- No susceptibility to motion sickness, according to the Motion Sickness Susceptibility Questionnaire (MSSQ)
Exclusion Criteria:
- Age under 18 years
- Specific cause responsible for the neck pain (cancer, fracture, etc.)
- Signs of sensorimotor dysfunction (dizziness, vestibular disorders)
- Susceptibility to motion sickness, according to the MSSQ
- Vision problems
- Altered comprehension or inability to speak fluent French
- Inability to provide written informed consent or to take part in a semi-structured interview
Sites / Locations
- Université Catholique de Louvain
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
People with chronic non-specific neck pain
Arm Description
Group of people with chronic non-specific neck pain who agreed to participate in a semi-structured interview about their experience using an immersive virtual reality serious game at home
Outcomes
Primary Outcome Measures
General experience with the virtual reality serious game
Participants' responses based on the questions asked in the semi-structured interviews
Secondary Outcome Measures
Full Information
NCT ID
NCT05244681
First Posted
February 7, 2022
Last Updated
February 27, 2023
Sponsor
Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique
1. Study Identification
Unique Protocol Identification Number
NCT05244681
Brief Title
Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain
Official Title
Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain: A Qualitative Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique
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
Background: Immersive virtual reality (VR) has been used for several years in the treatment of chronic neck pain. This new type of rehabilitation device, which can be used at home, is promising and seems to be as effective as conventional treatments for neck pain. Exploring the experience of people with chronic neck pain using this type of rehabilitation device at home could, among other things, help to understand the factors favoring good adherence and those not favoring it. This could also help us to improve VR home rehabilitation programs according to the patients' needs, preferences and expectations. However, currently, no studies have qualitatively evaluated the experience of people with chronic non-specific neck pain using an immersive VR serious game at home.
Objective: To explore the experience of people with chronic non-specific neck pain who used an immersive VR serious game at home.
Methods: Individual semi-structured interviews will be conducted with people with chronic non-specific neck pain. Interviews will last for approximately 30 to 60 minutes and will be carried out face-to-face or via videoconference (Microsoft Teams), depending on up-to-date guidance relating to the Covid-19 pandemic. Semi-structured interviews will be audio-recorded and transcribed verbatim. The transcripts will be read several times and analyzed using thematic analysis, with themes emerging from the transcripts (inductive approach). These themes will be defined and revised throughout the analysis process.
Discussion: Study findings will help to better understand the experience of people with chronic non-specific neck pain using a VR serious game at home, and then will allow to adapt it to the subjects' needs, preferences and expectations. These adaptations could further increase adherence to treatment and/or improve clinical outcomes for people with chronic non-specific neck pain using this type of rehabilitation device at home.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Neck Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
People with chronic non-specific neck pain
Arm Type
Other
Arm Description
Group of people with chronic non-specific neck pain who agreed to participate in a semi-structured interview about their experience using an immersive virtual reality serious game at home
Intervention Type
Other
Intervention Name(s)
Semi-structured interview
Intervention Description
Semi-structured interview to explore the experience of people with chronic non-specific neck pain who used an immersive virtual reality serious game at home
Primary Outcome Measure Information:
Title
General experience with the virtual reality serious game
Description
Participants' responses based on the questions asked in the semi-structured interviews
Time Frame
30-60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (over 18 years), men or women, living in Belgium
Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain)
To speak fluent French and to be able to provide informed consent to take part in an interview
To be able to take part in a semi-structured interview
No susceptibility to motion sickness, according to the Motion Sickness Susceptibility Questionnaire (MSSQ)
Exclusion Criteria:
Age under 18 years
Specific cause responsible for the neck pain (cancer, fracture, etc.)
Signs of sensorimotor dysfunction (dizziness, vestibular disorders)
Susceptibility to motion sickness, according to the MSSQ
Vision problems
Altered comprehension or inability to speak fluent French
Inability to provide written informed consent or to take part in a semi-structured interview
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Detrembleur, PhD
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université Catholique de Louvain
City
Bruxelles
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain
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