NCT04748367

Brief Summary

Paediatric immunization is often associated with significant fear and anxiety among children and their parents. Their distress can greatly affect their future adherence to the immunization schedule and the acceptance of recommended vaccines by physicians. This pilot was a single-centre, open label, randomised controlled trial to examine the use of VR analgesia in childhood immunization in primary care.The study primarily aimed to determine the feasibility of using immersive virtual reality (VR) during immunization in children by assessing the response rate of the participants during recruitment. The secondary outcome of the study was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children during immunization compared to usual care without VR. It also aimed to determine the effectiveness of immersive VR in reducing anxiety among the parents and nurses during immunization procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 1, 2021

Last Update Submit

February 6, 2021

Conditions

PainAnxiety

Keywords

virtual realitypainanxietychildrenimmunization

Outcome Measures

Primary Outcomes (1)

  • Feasibility( the response rate of recruitment) using immersive VR during immunization in children,

    Response rate of recruitment (number of participants agree to participate divided by the total number of screened participants, expressed in % )

    within 10 minutes

Secondary Outcomes (7)

  • Change children's pain score, using Faces Pain Scale-Revised (FPS-R)

    30 mins ( assess before and after immunisation)

  • Change in children's anxiety score, using Children's Fear Scale (CFS)

    30 mins ( assess before and after immunisation)

  • Change in parent's anxiety score, using Anxiety Visual Analogue Scale(VAS)

    30 mins ( assess before and after immunisation)

  • Change in nurses anxiety score, using Anxiety Visual Analogue Scale(VAS)

    30 mins ( assess before and after immunisation)

  • Simplicity of VR application during immunization by nurses

    5 mins

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Children wear VR headset during immunisation

Device: Virtual Reality Headset

Control group

NO INTERVENTION

Children did not wear VR headset during immunisation( usual care)

Interventions

Virtual Reality HeadsetDEVICE

Virtual Reality Headset running SILVER software

Intervention group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children of both gender and of any ethnicity are eligible to participate.
  • Parent (father or mother) or legal guardian or legal representative of the above children who accompany them to the polyclinic for immunization.
  • Registered nurses who are assigned to the immunization service stations during the period of the study.

You may not qualify if:

  • Children who are diagnosed with any disability or are deemed incapable of providing assent to the study will be excluded.
  • Children with pre-existing epilepsy/seizure or migraine
  • Caregivers including domestic helpers, grandparents, other relatives or nannies will be excluded.
  • Parent (father or mother) or legal guardian or legal representative who are affected by any disability which renders them incapable of providing consent will also be excluded.
  • Enrolled nurses or relief registered nurses at the study site will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Polyclinics-Sengkang

Singapore, 545025, Singapore

Location

Related Publications (1)

  • Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022.

    PMID: 35402359DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Zi Ying Chang

    SingHealth Polyclinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Deputy Clinic Director (SingHealth Polyclinic-Punggol branch)

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 10, 2021

Study Start

September 9, 2020

Primary Completion

December 11, 2020

Study Completion

December 11, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)