NCT05244681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 7, 2022

Last Update Submit

February 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • General experience with the virtual reality serious game

    Participants' responses based on the questions asked in the semi-structured interviews

    30-60 minutes

Study Arms (1)

People with chronic non-specific neck pain

OTHER

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

Other: Semi-structured interview

Interventions

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

People with chronic non-specific neck pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Catholique de Louvain

Brussels, Belgium

Location

Study Officials

  • Christine Detrembleur, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 17, 2022

Study Start

March 11, 2022

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations