NCT05973162

Brief Summary

The aim of this randomized controlled trial is to find the effectiveness of Virtual reality as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain, anxiety and enhancing elbow range of motion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

July 25, 2023

Last Update Submit

August 31, 2023

Conditions

Burns ElbowsPediatric ALL

Keywords

Virtual RealityPediatric burn patients,transverse friction massageElbow burn injuries

Outcome Measures

Primary Outcomes (1)

  • Mayo Elbow Performance Index

    MEPI is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL). This specific test uses 4 subscales: * Pain, * Range of Motion * Stability * Daily Function The clinical information is rated based on a 100 points scale. * \<60 - poor * 60-74 - fair * 75-89 - good * 90-100 - excellent

    2 weeks

Secondary Outcomes (2)

  • Burn Specific Pain Anxiety Scale (BSPAS)

    2 weeks

  • Goniometer

    2 weeks

Study Arms (2)

Virtual Reality training

ACTIVE COMPARATOR

Virtual Reality + Conventional PT

Other: Virtual Realty Training

Transverse friction massage (TFM)

EXPERIMENTAL

Transverse friction massage (TFM)+ Conventional PT

Other: Transverse friction massage (TFM)

Interventions

Virtual Realty TrainingOTHER

They would be receiving treatment as follow: Virtual Reality is a technology that aims to completely immerse the user inside the computer generated world, giving the impression to the user that they have "stepped inside" the synthetic world. RA mobile phone , head mounted display (HMD) will be used and videos of patient's interest will be played on phone which will create a 3D world around the patient. And while watching conventional physical therapy will be performed side by side. Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises

Virtual Reality training
Transverse friction massage (TFM)OTHER

They would be receiving treatment as follow: Transverse friction massage (Soft tissue mobilization technique) on the surrounding burn region for 5-10min in intervals. Frequency: 3 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 10 mins Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises

Transverse friction massage (TFM)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Willingly participated in the study.
  • Age group:6-18.
  • Gender: both Male and Female
  • Acute burn injuries of elbow region (grade 2)
  • Superficial wounds healing phase( 5-10) days
  • TBSA is less than 20%

You may not qualify if:

  • Motion sickness
  • History of seizure activity
  • Burns on body region that impede use of VR equipment (ears, eyes, head)
  • Deep burn (Grade 3,4)
  • Fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)

Islamabad, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kinza Anwar, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kinza Anwar, MS-OMPT

CONTACT

+92-3239735427kinza.anwar@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

August 30, 2023

Primary Completion

March 28, 2024

Study Completion

April 28, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)