Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control

Pain Clinical Trial

— PEDSPAINVR  

Official title:

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03480724
• Other study ID #: 2016-6501
• Status: Terminated
• Phase: N/A
• Start date: July 6, 2017
• Est. completion date: October 27, 2023

Study information

• Verified date: January 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure 1) powered by the laptop pc (Figure 2) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above. Group 2: Google Cardboard VRHMD This group will receive BTI's per conventional protocols. They will wear the Google cardboard VRHMD (Figure 3) powered by iPod touch/smartphone (Figure 4) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above. Group 3. Control This group will receive BTI's per conventional protocols without VRA intervention.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Google Cardboard VRA
Intervention was randomized and shuffled.
• Oculus Rift VRA
Intervention was randomized and shuffled.

Locations

Country	Name	City	State
United States	E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	American Academy of Physical Medicine and Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of severity of anxiety	Measurement of anxiety using Short State-Trait Anxiety Inventory (STAI) Anxiety scale which is a self-evaluation questionnaire completed by the patient's parent or guardian about how they feel and how the child feels at that moment.; It consists of 6 questions each having scale 1-4. 1 being Not at all and 4 being Very much. The questions are as follows: I feel calm; I am tense; I feel upset; I am relaxed; I feel content; I am worried	About 20 minutes per patient