- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490693
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Pain, Anxiety and Fear
December 5, 2022 updated by: ümmühan kılıç, Ondokuz Mayıs University
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.
Study Overview
Detailed Description
The study will be applied to children in the 5-10 group who will undergo burn dressing.
During the dressing, children will be watched cartoons with virtual reality glasses and pain, anxiety and fear will be looked at before and after the dressing.
The children in the control group will be given routine applications of the clinic.
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Samsun, Turkey, 34100
- 19May University
-
-
İlkadım
-
Samsun, İlkadım, Turkey
- omu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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,
- 1st 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
Exclusion Criteria:
- Child and family refusal to participate in the study
- 3rd 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain, anxiety, fear scores,
Time Frame: July 2022-October 2022
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2022
Primary Completion (Actual)
September 5, 2022
Study Completion (Actual)
October 2, 2022
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 4, 2022
First Posted (Actual)
August 8, 2022
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 5, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- OMU (Other Identifier: Ondokuz Mayıs University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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