NCT05490693

Brief Summary

This work; It was planned as a randomized controlled study to determine the effect of watching cartoons with virtual reality glasses during burn dressing of children aged 5-10 years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling of pain, anxiety and fear in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

July 24, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

August 1, 2022

Last Update Submit

December 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain, anxiety, fear scores,

    We will evaluate the pain, anxiety, fear score with the Wong Baker Pain Scale before and after dressing in the trial and control group.reality glasses compared to the control group.

    July 2022-October 2022

Interventions

Experimental group: 26 control group group: 26

Also known as: control group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

In order to determine the number of samples, power analysis was performed using the G\*power program. The effect size coefficient was calculated by using the Newcastle satisfaction scale averages in source 1 (thesis), and the effect size = 0.76, and it was decided to recruit at least 26 people in each group in order to obtain 80% power at the ɑ=0.05 level, a total of 52 people in the two groups.

You may qualify if:

  • The child and family agree to participate in the research,
  • The child does not have a disease that causes chronic pain,
  • The child is between the ages of 5-10,
  • st and 2nd degree burns of less than 10% of the body surface area of the child,
  • Local burn, no facial burn
  • The child has no mental or neurological disability
  • Failure to intervene in the child with general anesthesia
  • The child has no eye problems

You may not qualify if:

  • Child and family refusal to participate in the study
  • rd and 4th degree burns of more than 10% of the body surface area of the child,
  • The child is less than 5 years old and over 10 years old
  • The child has a mental or neurological disability
  • Intervention of the child with general anesthesia
  • The child has an eye problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Omü

Samsun, İlkadım, Turkey (Türkiye)

Location

19May University

Samsun, 34100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 8, 2022

Study Start

July 24, 2022

Primary Completion

September 5, 2022

Study Completion

October 2, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations