AnxietyRelaxation-VRNCT04666506
Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
An observational study of Anxiety and Pain, run by Thomas More University of Applied Sciences at 2 sites in Belgium.
Trial summary
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- What is being tested?
- Virtual reality
- Type of treatment
- Vaccines
- How many people
- 53 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 Jan 2021to 16 May 2021
- Phase
- Observational
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo a medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and/or is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff. Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study.
Who may be able to join
- Written informed consent must be obtained
- Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo treatment or a single medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff*.
- For example (but not limited to), for the relaxation module of the VR intervention, following paediatric patients can be recruited: paediatric patients awaiting surgery, paediatric patients post-surgery during their (brief) stay in the recovery unit, paediatric patients staying at the oncological department, paediatric patients with eating disorders in need of relaxation after having eaten, or paediatric patients experiencing psychosomatic complaints (e.g. stomach ache).
- For example, for the distraction module of the VR intervention, following paediatric patients can be recruited: paediatric patients undergoing a single medical (nursing procedure) such as (but not limited to) wound care, blood draw or vaccination.
- Age range of ≥ 4 and ≤ 16
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study. In a real-life situation, the clinical staff chooses appropriate care methods (e.g. means of distraction or medication) based on their clinical expertise (in addition to treatment and pain management protocols). Therefore, the overall feasibility, acceptability, tolerability and initial clinical effect of the VR application are explored for an 'as-broad-as-possible' population, in order to provide information on what works best for whom with respect to Relaxation-VR. This practice-oriented approach allows us to investigate the potential of a VR intervention for a larger population, which could have the largest impact for the paediatric population and the clinical staff.
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)
- Patient will undergo a medical procedure or treatment that is considered unsuitable in combination with the use of a VR headset, as assessed by the clinical staff (e.g., facial wound care)
- Non-Dutch native 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
2 sites in 1 country.
Belgium2 sites
UZ Brussel
Jette, Vlaams-Brabant, 1090
AZ Sint-Maarten
Mechelen, Antwerpen, 2800
About this study
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
Read the detailed description
Current pain and anxiety management for children in hospital includes pharmacological analgesia (e.g. opioid therapy) with potential negative side effects. In addition, a non-pharmacological approach involves various distraction techniques, either passive (e.g., music, movies) or active (e.g., interactive toys, electronic games, storytelling by the nursing staff). However, these distraction techniques can often be time consuming for the already busy and even over-demanded nursing staff.
A combination of distraction, extinction learning, cognitive-behavioral principles, mindful meditation, stress reduction, gate-control theory, and the spotlight theory of attention is believed to be the mechanism behind VR's effectiveness in pain management. Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures, intravenous injections, burn wound care and rehabilitation. In particular, a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain (14 studies) and anxiety (7 studies) than care as usual (CAU), with large effect size. Moreover, for chest radiography, the use of VR has also significantly reduced procedure time, while increasing patient satisfaction. As such, adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice.
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
- Being tested
- Virtual reality
- Keywords
- Virtual reality, VR, paediatric, distraction, pain, anxiety, relaxation
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Also called Relaxation-VR
The VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital.
The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog).
| Study group | Role | What they receive |
|---|---|---|
| VR as distraction during a medical procedure | Paediatric outpatients undergoing a medical procedure, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a distraction method during a potentially painful or scary procedure (e.g., vaccination, wound care, venipuncture,...). Receives: Other: Virtual reality | |
| VR as relaxation method during a hospital stay | Paediatric inpatients, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a relaxation method during a potentially stressful hospital stay (e.g., patients with psychosomatic complaints, patients with eating disorders,...). Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire)
This questionnaire is based on the Simulator Sickness Questionnaire (SSQ) and is used to assess physical adverse events due to the VR intervention. The query language of the SSQ was simplified for children and modified Wong-Baker faces were added to create a Peds SSQ, with a score of 0 (happy face) indicating no adverse event and a score of 6 (unhappy face) indicating more severe adverse event. The Peds SSQ, in accordance with the SSQ, contains queries that probe four symptom categories: eye strain, head and neck discomfort, sleepiness or fatigue, and dizziness or nausea. A lower score indicates a better outcome.
Measured: Immediately after the intervention.
Feasibility as assessed by the paediatric participants
Survey comprised of a combination of open-ended and response-set questions. Ease of use assessed with Visual Analogue Scale (VAS) ranging from 0 (very easy) to 100 (very difficult).
Fun assessed with Visual Analogue Scale (VAS) ranging from 0 (A lot of fun to 100 (No fun at all).
Measured: Immediately after the intervention
Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)
Survey comprised of a combination of open-ended and response-set questions.
Measured: Immediately after the intervention
Feasibility as assessed by a parent of the paediatric patient
Survey comprised of a combination of open-ended and response-set questions. E.g. Did the child keep the VR-headset on during the entire procedure?
Measured: Immediately after the intervention
Acceptability as assessed by a parent of the paediatric patient
Survey comprised of a combination of open-ended and response-set questions. E.g., Why did you want to try it? Would you use it again?
Measured: Immediately after the intervention
Secondary outcomes (3)
Changes in anxiety levels from pre-to-post intervention session: Visual Analogue Scale (VAS)
A visual analogue scale (VAS) for anxiety will be used to assess the anxiety levels. The VAS is a 10-cm horizontal line marked with the words "not anxious" (0, low score) at the left end and "very anxious" (100, high score) at the right end, with different facial expressions drawn along the line. The VAS is a widely used scale which is reliable and valid for measuring the subjective feelings of children.
Measured: Immediately before and after the intervention.
Changes in pain levels from pre-to-post intervention session: Faces Pain Rating Scale-Revised (FPRS-R)
The FPS-R is a self-report measure used to assess the intensity of children's pain and comprises a scale of 0-10 comprising six horizontally arranged cartoon faces with expressions of "0 = no pain" to "10 = very painful". Participants will be asked to indicate the face that illustrates how much pain he/she feels. The FPS-R is shown to be appropriate for use in assessment of the intensity of children's acute pain from age 4 onward. The FPS-R is a reliable and valid scale for evaluating pain in children
Measured: Immediately before and after the intervention.
Changes in emotion (happiness and arousal/stress) levels from pre-to-post intervention session: Two items of the Self-Assessment Manikin (SAM)
The Self-Assessment Manikin (SAM) is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, (and dominance = item that is left out) associated with a person's affective reaction to a wide variety of stimuli. A continuum of five stylized human figures (manikins) depicts feeling very happy (score of 1) to very sad (score of 9). For arousal, a second continuum of five stylized manikins depicts feeling very calm (score of 1) to very tense (score of 9). SAM is an inexpensive, easy method for quickly assessing reports of affective response in many contexts.
Measured: Immediately before and after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start4 Jan 2021
- Primary completion16 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas More University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, Algemeen Ziekenhuis Sint_Maarten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666506
- Sponsor's protocol ID
- IC_PED_01
- Acronym
- Relaxation-VR
- Status last verified
- May 2021
- First submitted
- 1 Dec 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
- ClinicalTrials.gov ID
- NCT04666506
- Acronym / sponsor ID
- Relaxation-VR / IC_PED_01
- Keywords
- Virtual reality, VR, paediatric, distraction, pain, anxiety, relaxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Thomas More University of Applied SciencesUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, Algemeen Ziekenhuis Sint_Maarten
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 14 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.
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
Detailed description
Current pain and anxiety management for children in hospital includes pharmacological analgesia (e.g. opioid therapy) with potential negative side effects. In addition, a non-pharmacological approach involves various distraction techniques, either passive (e.g., music, movies) or active (e.g., interactive toys, electronic games, storytelling by the nursing staff). However, these distraction techniques can often be time consuming for the already busy and even over-demanded nursing staff.
A combination of distraction, extinction learning, cognitive-behavioral principles, mindful meditation, stress reduction, gate-control theory, and the spotlight theory of attention is believed to be the mechanism behind VR's effectiveness in pain management. Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures, intravenous injections, burn wound care and rehabilitation. In particular, a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain (14 studies) and anxiety (7 studies) than care as usual (CAU), with large effect size. Moreover, for chest radiography, the use of VR has also significantly reduced procedure time, while increasing patient satisfaction. As such, adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice.
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR as distraction during a medical procedure | – | Other: Virtual realityPaediatric outpatients undergoing a medical procedure, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a distraction method during a potentially painful or scary procedure (e.g., vaccination, wound care, venipuncture,...). |
| VR as relaxation method during a hospital stay | – | Other: Virtual realityPaediatric inpatients, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a relaxation method during a potentially stressful hospital stay (e.g., patients with psychosomatic complaints, patients with eating disorders,...). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo a medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and/or is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff. Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study.
Key inclusion criteria (8 listed)
- Written informed consent must be obtained
- Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo treatment or a single medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff*.
- Age range of ≥ 4 and ≤ 16
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
Key exclusion criteria (5 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)
- Patient will undergo a medical procedure or treatment that is considered unsuitable in combination with the use of a VR headset, as assessed by the clinical staff (e.g., facial wound care)
- Non-Dutch native 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 |
|---|---|---|
| Virtual realityAlso: Relaxation-VRThe VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital. The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog). | Other | VR as distraction during a medical procedure, VR as relaxation method during a hospital stay |
Primary outcome
Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire)
Time frame: Immediately after the intervention.
This questionnaire is based on the Simulator Sickness Questionnaire (SSQ) and is used to assess physical adverse events due to the VR intervention. The query language of the SSQ was simplified for children and modified Wong-Baker faces were added to create a Peds SSQ, with a score of 0 (happy face) indicating no adverse event and a score of 6 (unhappy face) indicating more severe adverse event. The Peds SSQ, in accordance with the SSQ, contains queries that probe four symptom categories: eye strain, head and neck discomfort, sleepiness or fatigue, and dizziness or nausea. A lower score indicates a better outcome.
Feasibility as assessed by the paediatric participants
Time frame: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. Ease of use assessed with Visual Analogue Scale (VAS) ranging from 0 (very easy) to 100 (very difficult). Fun assessed with Visual Analogue Scale (VAS) ranging from 0 (A lot of fun to 100 (No fun at all).
Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)
Time frame: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions.
Feasibility as assessed by a parent of the paediatric patient
Time frame: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. E.g. Did the child keep the VR-headset on during the entire procedure?
Acceptability as assessed by a parent of the paediatric patient
Time frame: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. E.g., Why did you want to try it? Would you use it again?
3 secondary outcomes
Changes in anxiety levels from pre-to-post intervention session: Visual Analogue Scale (VAS)
Time frame: Immediately before and after the intervention.
Changes in pain levels from pre-to-post intervention session: Faces Pain Rating Scale-Revised (FPRS-R)
Time frame: Immediately before and after the intervention.
Changes in emotion (happiness and arousal/stress) levels from pre-to-post intervention session: Two items of the Self-Assessment Manikin (SAM)
Time frame: Immediately before and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Pain, run by Thomas More University of Applied Sciences at 2 sites 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire) (time frame: Immediately after the intervention.). The study lists 5 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 2 Jun 2021.