SurgeryNCT04658030
Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.
A study testing VR 360 video surgery preparation and Care as usual in people with Surgery, run by Thomas More University of Applied Sciences at 1 site in Belgium.
Trial summary
Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- VR 360 video surgery preparation and Care as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent must be obtained
- Inpatient or outpatient in the study site (Heilig Hart Hospital Lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021).
- Age range of ≥ 6 and ≤ 12
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
Who cannot join
- Patient has a history of seizure disorders (e.g. epilepsy)
- Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
- Non-Dutch/English/French speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
- Previous enrolment in this study (during a previous hospital stay)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Heilig Hart Ziekenhuis Lier
Lier, Flanders, 2500
Marieke Deschacht, +32 3 491 23 63, Marieke.Deschacht@heilighartlier.be
About this study
Official title: 360° Video VR Surgery Preparation: Feasibility, Acceptability, Tolerability and Initial Effectiveness of Virtual Reality for Children in a Flemish Hospital.
Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.
This is one of the case studies from the larger project titled: 360 ° video VR surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a Flemish hospital.
Read more
Domain: This scientific study will take place in 1 hospital on the pediatric ward. The target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved.
Target:
- Assess the acceptability, feasibility and tolerability of the 360 ° video VR surgery preparation.
- Assess the effectiveness of the 360 ° video VR surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (CAU *).
- CAU in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.
- Conditions
- Surgery
- Being tested
- VR 360 video surgery preparation, Care as usual
- Keywords
- Pediatrics, Preparation, Virtual Reality, 360 Video, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR 360 video surgery preparationDevice
Preparing children on the surgery by a virtual reality 360 degrees video tour from the pediatric ward to the surgery room. In this video all information is given necessary for the surgery. This takes a maximum of 30 minutes and will be performed 1 time.
Care as usualOther
Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home.
| Study group | Role | What they receive |
|---|---|---|
| VR 360 video surgery preparation | Experimental | Preparing pediatric patients for surgery with a newly developed VR 360 degree video. Maximum 30 minutes, one time. Receives: Device: VR 360 video surgery preparation |
| Care as usual | Active comparator | Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in staff attitude towards the intervention
Unified theory of acceptance and use of technology tests the acceptance of the staff towards the intervention in this study.
Assess change in patient attitude towards the intervention with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" to "Totally agree". The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the intervention.
Measured: Staff: Measurement takes place in week 5 after the start of the study.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
Assessment of physical side effects after exposure to VR by the Pediatric Simulator Sickness Questionnaire (Peds SSQ).
The Peds SSQ contains queries that probe 4 symptom categories: (1) eye strain (queries 1-4); (2) head and neck discomfort (queries 5 and 6); (3) sleepiness (solipsism) or fatigue (queries 7 and 8); and dizziness or nausea (visually induced motion sickness, queries 9-13). The scale that is used is a likert scale (with additional faces) ranging from 0 to 6 per query (0 = no of the above "complaints"; 6 = a lot of the above "complaints".
Measured: Immediately after the intervention
Usability of the intervention: System Usability Scale (SUS)
Assessment of ease of use of the intervention with the System Usability Scale (SUS). The SUS is a 10 item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree". A higher SUS score indicates better usability.
Measured: Immediately after the intervention.
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options. Higher scores indicate higher satisfaction.
Measured: Immediately after the intervention
Intervention adherence
Measure intervention adherence by registering the number of fully completed sessions.
Measured: Immediately after the intervention
Procedure time
The procedure time of intervention in minutes
Measured: Immediately after the intervention
Secondary outcomes (1)
Preliminary effectiveness (change in anxiety between timepoints) (Intervention and control)
Measuring procedural anxiety (with a Visual Analogue Scale) (1.Before intervention/control, 2. just after intervention/control and 3.just before surgery)
Measured: Measurement 1: Immediately after signing the informed consent, day 1 of study. Measurement 2: Immediately after the intervention, day 1 of study. Measurement 3: Just before surgery, day 4 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Mar 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas More University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Regionaal Ziekenhuis Heilig Hart Tienen, Fotosfeer
- Responsible party
- Sponsor
- Investigators
- Wessel van de Veerdonk, PhD, Principal investigator, Thomas More University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658030
- Sponsor's protocol ID
- IC_PED_2
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 360° Video VR Surgery Preparation: Feasibility, Acceptability, Tolerability and Initial Effectiveness of Virtual Reality for Children in a Flemish Hospital.
- ClinicalTrials.gov ID
- NCT04658030
- Acronym / sponsor ID
- IC_PED_2
- Conditions
- Surgery
- Keywords
- Pediatrics, Preparation, Virtual Reality, 360 Video, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thomas More University of Applied SciencesUniversity, hospital or other
- Collaborators
- Regionaal Ziekenhuis Heilig Hart Tienen, Fotosfeer
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.
This is one of the case studies from the larger project titled: 360 ° video VR surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a Flemish hospital.
Domain: This scientific study will take place in 1 hospital on the pediatric ward. The target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved.
Target:
- Assess the acceptability, feasibility and tolerability of the 360 ° video VR surgery preparation.
- Assess the effectiveness of the 360 ° video VR surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (CAU *).
- CAU in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR 360 video surgery preparation | Experimental | Device: VR 360 video surgery preparationPreparing pediatric patients for surgery with a newly developed VR 360 degree video. Maximum 30 minutes, one time. |
| Care as usual | Active comparator | Other: Care as usualPreparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent must be obtained
- Inpatient or outpatient in the study site (Heilig Hart Hospital Lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021).
- Age range of ≥ 6 and ≤ 12
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
Key exclusion criteria (4 listed)
- Patient has a history of seizure disorders (e.g. epilepsy)
- Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
- Non-Dutch/English/French speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
- Previous enrolment in this study (during a previous hospital stay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR 360 video surgery preparationPreparing children on the surgery by a virtual reality 360 degrees video tour from the pediatric ward to the surgery room. In this video all information is given necessary for the surgery. This takes a maximum of 30 minutes and will be performed 1 time. | Device | VR 360 video surgery preparation |
| Care as usualPreparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home. | Other | Care as usual |
Primary outcome
Change from baseline in staff attitude towards the intervention
Time frame: Staff: Measurement takes place in week 5 after the start of the study.
Unified theory of acceptance and use of technology tests the acceptance of the staff towards the intervention in this study. Assess change in patient attitude towards the intervention with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" to "Totally agree". The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the intervention.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
Time frame: Immediately after the intervention
Assessment of physical side effects after exposure to VR by the Pediatric Simulator Sickness Questionnaire (Peds SSQ). The Peds SSQ contains queries that probe 4 symptom categories: (1) eye strain (queries 1-4); (2) head and neck discomfort (queries 5 and 6); (3) sleepiness (solipsism) or fatigue (queries 7 and 8); and dizziness or nausea (visually induced motion sickness, queries 9-13). The scale that is used is a likert scale (with additional faces) ranging from 0 to 6 per query (0 = no of the above "complaints"; 6 = a lot of the above "complaints".
Usability of the intervention: System Usability Scale (SUS)
Time frame: Immediately after the intervention.
Assessment of ease of use of the intervention with the System Usability Scale (SUS). The SUS is a 10 item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree". A higher SUS score indicates better usability.
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
Time frame: Immediately after the intervention
Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options. Higher scores indicate higher satisfaction.
Intervention adherence
Time frame: Immediately after the intervention
Measure intervention adherence by registering the number of fully completed sessions.
Procedure time
Time frame: Immediately after the intervention
The procedure time of intervention in minutes
1 secondary outcome
Preliminary effectiveness (change in anxiety between timepoints) (Intervention and control)
Time frame: Measurement 1: Immediately after signing the informed consent, day 1 of study. Measurement 2: Immediately after the intervention, day 1 of study. Measurement 3: Just before surgery, day 4 of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wessel van de Veerdonk, PhD principal investigator
Thomas More University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR 360 video surgery preparation and Care as usual in people with Surgery, run by Thomas More University of Applied Sciences at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wessel van de Veerdonk, PhD ((0)485 15 60 36 ext. +32, wessel.vandeveerdonk@thomasmore.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in staff attitude towards the intervention (time frame: Staff: Measurement takes place in week 5 after the start of the study.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.