- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745208
Simulation-Based Training on the Preparedness and Burden of Caregiver
The Effect of Simulation-Based Training on the Preparedness and Burden of Caregiver of Patients With Burns: A Randomised Controlled Study
Study Overview
Detailed Description
Method:
The study was designed as a randomised controlled study with the control group in order to determine the effect of simulation-based training applied to the caregivers of burn patients on their preparedness for care and caregiving burden. The research will be conducted in the Burn Unit of Hacettepe University Adult Hospital and Burn Center of Gulhane Training and Research Hospital. The population of the research includes caregivers of adult patients admitted to Hacettepe University Adult Hospital Burn Unit and Burn Center of Gulhane Training and Research Hospital after 02.02.2021 and have treatment in inpatient or outpatient clinics. Since there is no similar research in the literature, sample size was not calculated. At the end of the study, power analysis will be done to evaluate the adequacy of the sample size. In the study, participants in the intervention group and control group will be assigned by block randomization method and each block will consist of 4 caregivers and 6 blocks will be formed. The data sheets of the research are Caregivers Information Form, Preparedness for Caregiving Scale, Caregiving Burden Scale and Post-Discharge Assessment Form for Burn patients. In addition, the Questionnaire for the Burn patients will be used to obtain information about the burn patients.
Implementation of study:
The control group will receive only the standard discharge education. Simulation based education will be performed after the standard discharge training with the intervention group. The preparedness of caregivers before and after both training will be assessed. The burden of caregiving will be assessed during the first and third months of care.
Collection of Data:
In order to test the understandability of standard discharge training, training will be provided to 3 patient relatives. The presentation of the training will be organized according to the feedback received.
After the pre-application of the simulation scenario in the laboratory environment 3 times, the necessary changes will be made on the scenario and the final version will be given.
Data collection tools will be applied on the both group, unrecognized questions and corrections will be made on missing items. Individuals participating in these preliminary studies will not be included in the study.
Percentage, mean, standard deviation will be used in the evaluation of the data. Chi-square, Fisher's exact test, independent paired T-test and Mann-Whitney U test will be used for comparison between groups and within groups. p <0.05 will be considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacettepe University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caring for patients with burn during the study
- Being over 18 years old
- Agree to participate voluntarily in the study
- To communicate
- Not having a diagnosed mental problem
- The burn patient he/she cares for is over the age of 18, inpatient treatment in the burn unit, no communication problem, no diagnosed mental problem, no additional problem (fracture, paralysis, etc.) except burn.
- At least 5 days to be discharged from the burns patient,
- Not being a healthcare professional
- Not caring for another family member, except burn patients.
Exclusion Criteria:
- Loss of life of the burned individual and/or caregiver during the study.
- The participant declares that he/she wants to leave at any stage of the study.
- Not participating in data collection in the first and third months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard discharge education
The control group will receive only the standard discharge education.
|
|
Experimental: standard discharge education+Simulation based education
The intervention group will receive standard discharge education and then simulation based education will be performed
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high fidelity simulation with moulage
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caregiving burden
Time Frame: from first month until third month
|
The caregiver burden score will be assessed by Burden Scale for Family Caregivers.
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from first month until third month
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Preparedness of care
Time Frame: First assessment at time of acceptance of the study -2 day after education
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The readiness of caregiving will be assessed at the time of acceptence and post-training education by Preparedness for Caregiving Scale.
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First assessment at time of acceptance of the study -2 day after education
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burn Patient Fallow Up
Time Frame: 3 months
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Burn patients will be fallowed from through 3 months and complications, rehospitalizations number, etc. will be recorded.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zahide Tuncbilek, Asst. Prof., Hacettepe University
Publications and helpful links
General Publications
- Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
- Deshpande, O. N., Puri, V., Vora, S. S., Shende, N. N., & Choudhary, S. C. (2012). Socio-economic burden of burns: How do the families of patients cope? Indian journal of burns, 20(1), 48.
- Evgeniou E, Loizou P. Simulation-based surgical education. ANZ J Surg. 2013 Sep;83(9):619-23. doi: 10.1111/j.1445-2197.2012.06315.x. Epub 2012 Oct 22.
- Faydali, S., & Bayraktar, N. (2011). Yanıklı Hastaların ve Yakınlarının Taburculuk Sonrası Bilgi Düzeylerinin Belirlenmesi. Turkish Journal of Research & Development in Nursing, 13(1).
- Fletcher JD, Wind AP. Cost considerations in using simulations for medical training. Mil Med. 2013 Oct;178(10 Suppl):37-46. doi: 10.7205/MILMED-D-13-00258.
- Grasel, E., Chiu, T., & Oliver, R. (2003). Development and validation of the Burden Scale for Family Caregivers. Toronto: Comprehensive Rehabilitation and Mental Health Services.
- Jutten LH, Mark RE, Maria Janssen BWJ, Rietsema J, Droes RM, Sitskoorn MM. Testing the effectivity of the mixed virtual reality training Into D'mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study. BMJ Open. 2017 Aug 21;7(8):e015702. doi: 10.1136/bmjopen-2016-015702.
- Sullivan-Bolyai S, Bova C, Lee M, Johnson K. Development and pilot testing of a parent education intervention for type 1 diabetes: parent education through simulation-diabetes. Diabetes Educ. 2012 Jan-Feb;38(1):50-7. doi: 10.1177/0145721711432457. Epub 2012 Jan 5.
- Tofil NM, Rutledge C, Zinkan JL, Youngblood AQ, Stone J, Peterson DT, Slayton D, Makris C, Magruder T, White ML. Ventilator caregiver education through the use of high-fidelity pediatric simulators: a pilot study. Clin Pediatr (Phila). 2013 Nov;52(11):1038-43. doi: 10.1177/0009922813505901.
- Ulusoy N, Graessel E. Subjective burden of family caregivers with Turkish immigration background in Germany : Validation of the Turkish version of the Burden Scale for Family Caregivers. Z Gerontol Geriatr. 2017 Jun;50(4):339-346. doi: 10.1007/s00391-016-1044-y. Epub 2016 Jun 21.
- Zwicker, D. (2010). Try this: best practices in nursing care to older adults. Preparedness for caregiving scale. Hartford Institute for Geriatric Nursing, New York University of Nursing. Retrieved January, 15, 2011.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-19021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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