Virtual reality distraction for needle-related pain and distress in children and adolescents with autism spectrum disorder (ASD)
| ISRCTN | ISRCTN14514643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14514643 |
- Submission date
- 11/07/2023
- Registration date
- 12/07/2023
- Last edited
- 17/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This study aims to investigate the use of virtual reality (VR) as a distraction for pain management during blood draw procedures in children and adolescents with Autism Spectrum Disorder (ASD), with or without Intellectual Disability (ID). VR has shown promise in managing needle-related pain in typically developing children, but its use in children with ASD/ASD-ID is underexplored. VR technology can provide immersive images and block out real-world stimuli, potentially helping to distract individuals with ASD/ASD-ID during blood draw procedures. This research could have significant clinical benefits for healthcare practitioners working with this population, as it may provide an alternative to sedation, which can be high-risk and complicate routine medical care.
Who can participate?
Children and adolescents aged 5-18 years with a diagnosis of Autism Spectrum Disorder (ASD) with or without a co-occurring Intellectual Disability (ID), their parents/legal caregivers.
What does the study involve?
Participants will be randomly assigned to the VR condition or the control condition (treatment as usual) during the venipuncture procedure.
What are the possible benefits and risks of participating?
We cannot predict if there will be any benefits from participating in this study. However, by taking part participants will be contributing to emerging research on virtual reality distraction from pain during needle-related procedures in children with ASD/ASD-ID. This study includes a questionnaire that requires parents and children to reflect on the child’s experience of pain during the blood draw procedure, if participants become distressed or feel uncomfortable they will be provided with support by the medical team providing treatment.
Where is the study run from?
University Hospital Galway (Ireland)
When is the study starting and how long is it expected to run for?
September 2022 to March 2026
Who is funding the study?
Investigator-initiated and -funded
Who is the main contact?
Dr Helena Lydon, helena.lydon@universityofgalway.ie
Prof Brian McGuire, brian.mcguire@universityofgalway.ie
Conor O'Neill, C.ONeill53@nuigalway.ie
Contact information
Principal Investigator
School of Psychology
University of Galway
University Road
Galway
H91 EV56
Ireland
 ORCID ID |
0000-0002-8202-0843 |
|---|---|
| Phone | +353 91494457 |
| helena.lydon@universityofgalway.ie |
Study information
| Study design | Interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 43934 PIS_V2.Pdf |
| Scientific title | A comparison of virtual reality distraction and treatment as usual for needle-related pain and distress in children and adolescents with autism spectrum disorder (ASD): a feasibility study |
| Study hypothesis | Is Virtual Reality based distraction a feasible and more effective method than treatment as usual in reducing needle-related pain in a sample of children and adolescents with ASD with or without a co-occurring ID during a blood draw procedure? |
| Ethics approval(s) |
1. Approved 11/05/2023, Clinical Research Ethics Committee, Galway University Hospital (Room 2, 2nd Floor, HR Building, Merlin Park Hospital, Galway, -, Ireland; +353 91775022; colette.collins@hse.ie), ref: C.A. 2998 2. Submitted 05/12/2024, Clinical Research Ethics Committee, Galway University Hospital (Room 2, 2nd Floor, HR Building, Merlin Park Hospital, Galway, H91 N973, Ireland; +353 91775022; colette.collins@hse.ie), ref: C.A. 2998/Amendment 3. Submitted 09/10/2024, Children's Health Ireland Research Ethics Committee (Children's Health Ireland, Dublin, D12 N512, Ireland; -; ethics.committee2@childrenshealthireland.ie), ref: REC-539-24 |
| Condition | Children and adolescents with a diagnosis of Autism Spectrum Disorder (ASD) with or without a co-occurring Intellectual Disability (ID). |
| Intervention | Intervention Condition: Participants in the intervention condition will receive access to Virtual Reality (an Oculus Rift 2 and the VR app Ocean Rift) for the duration of their venipuncture procedure. Control Condition: Participants in the control condition will receive treatment as usual during their venipuncture procedure. Randomisation: The control/intervention groups will be selected using random assignment. This will be achieved using a computerised number generator (www.randomizer.org). One research who will not be involved in the data collection, will conceal participant allocations in numbered envelopes. Each participant will have a unique ID number and the ID numbers will be applied in sequence as participants enrol in the study. The condition to which the individual has been allocated will be revealed by opening the relevant numbered envelope and noting the group allocation (1 = VR intervention group, 2 = Treatment as usual). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. A task analysis of the venipuncture is gathered during the procedure 2. Pain is measured using a visual analogue scale (VAS) after the procedure 3. Feasibility data related to wearing the VR headset will be gathered after the procedure |
| Secondary outcome measures | Parent and Nurse/Phlebotomist Measures: 1. Behaviour measured by Behaviour Observation Checklist during the venipuncture. 2. Pain measured by visual analogue scale (VAS) during the procedure 3. Satisfaction with VR and venipuncture measured using Likert rating scales after the procedure |
| Overall study start date | 01/09/2022 |
| Overall study end date | 01/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Children and adolescents with a diagnosis of Autism Spectrum Disorder (ASD) with or without a co-occurring Intellectual Disability (ID), and their parents/legal caregivers 2. Have a venipuncture scheduled or attend the day ward and require a venipuncture. |
| Participant exclusion criteria | 1. Children under the age of 5 years and over the age of 18 years 2. Have not been clinically diagnosed as having ASD/ASD-ID 3. Children/adolescents with medical conditions that preclude virtual reality use such as epileptic seizures and vision problems 4. The inability to obtain consent from a parent/legal caregiver, and assent from a child |
| Recruitment start date | 13/07/2023 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Newcastle Road
Galway
H91 YR71
Ireland
Knocknaphunta
Castlebar
F23 H529
Ireland
Merlin Park
Galway
H91 N973
Ireland
Mill Road
Blanchardstown
Dublin
D15 RRN1
Ireland
Sponsor information
University/education
University Road
Galway
H91 TK33
Ireland
| Phone | +353 91 524411 |
|---|---|
| painresearch@nuigalway.ie | |
| Website | https://www.universityofgalway.ie |
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Helena Lydon Helena.lydon@universityofgalway.ie The data will be available following the publication of the research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 12/07/2023 | No | Yes |
Additional files
Editorial Notes
17/01/2025: The following changes were made to the trial record:
1. The ethics approvals 2, 3 were added.
2. The overall end date was changed from 01/03/2025 to 01/03/2026.
3. The recruitment end date was changed from 30/12/2024 to 30/06/2025.
4. The study participating centres Mayo University Hospital, Child and Adolescent Mental Health Services (CAMHS) Community Healthcare West, Children's Health Ireland were added.
18/12/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/12/2023 to 30/12/2024.
2. The overall study end date has been changed from 01/03/2024 to 01/03/2025 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/12/2024 to 30/12/2025.
29/08/2023: Internal review.
12/07/2023: Trial's existence confirmed by Clinical Research Ethics Committee, Galway University Hospital
