NCT03480724

Brief Summary

To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 6, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

6.3 years

First QC Date

April 14, 2017

Last Update Submit

January 2, 2024

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Severity of Pain Measurement

    Measurement of pain using the Face Legs Activity Cry Consolability scale (FLACC scale) which is a Behavioral Pain Assessment Scale. Each category is scored on the 0-2 scale, that results in total score of 0-10. 0= Relaxed and comfortable , 1-3 = Mild discomfort, 4-6=Moderate pain, 7-10= Severe discomfort or pain or both. Lower score is a good outcome and higher score is a bad outcome. The assessment is for all the subjects in the study.

    About 20 minutes per patient.

Secondary Outcomes (1)

  • Measurement of severity of anxiety

    About 20 minutes per patient

Study Arms (3)

Google Cardboard VRA

ACTIVE COMPARATOR

This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch.

Other: Google Cardboard VRA

Oculus Rift VRA

ACTIVE COMPARATOR

This group of subjects will receive VRA with Oculus Rift

Other: Oculus Rift VRA

Control

NO INTERVENTION

This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group

Interventions

Google Cardboard VRAOTHER

Intervention was randomized and shuffled.

Google Cardboard VRA
Oculus Rift VRAOTHER

Intervention was randomized and shuffled.

Oculus Rift VRA

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with spasticity requiring BTI
  • Children ages 5 - 18
  • Children who have contraindications for sedation for BTI
  • Children with intact vision who can attend VR intervention

You may not qualify if:

  • Children who have uncontrolled seizures \> than 4 per year
  • Children who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
  • Children on different treatments for spasticity such as baclofen pump, phenol block. For patients who receive phenol block, phenol block will be held during the visits with VR intervention to avoid confounding results
  • Children with poor bleeding control
  • Children who request general anesthesia/IV sedation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuxi Chen, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome accessor will have no patient contact and will not have access to the information on the type of intervention study patients were given.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

March 29, 2018

Study Start

July 6, 2017

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)