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
1 other identifier
interventional
60
1 country
1
Brief Summary
Major burn injuries are serious traumas that cause physical and psychological problems. The acute period that begins with admission to the hospital is followed by a rehabilitation period that lasts for months or even years. The main goal in the acute care of the patient in hospital is to discharge the patient from the hospital as soon as possible, with the least morbidity, functional and cosmetic loss. The care of the patient in rehabilitation period continues at home, and the home care is provided by informal caregivers. Due to the physiological and psychological changes occurring in the patient with burns, the informal caregiver has important duties such as; helping with or doing feeding, wound care, personal care, organizing household chores, providing economic, medical and psychological support. So that, informal caregivers may experience lack of information and anxiety. Nurses should include the informal caregivers in discharge education to meet the information requirement of them, to prepare them for home care and to reduce anxiety of home care. The basis of discharge education is to help individual to cope with the problems related to the disease and to maintain individual care. Nurses, who play a key role in discharge education, have been keeping up with the change over the years and trying to maintain the effectiveness of education by various methods. The educational environment enriched with different technological tools and materials used in the field of education makes it easier to provide a change of behavior in the desired direction in the learner. A controlled and safe simulation environment ensures patient safety at all times, while ensuring that training is tailored specifically to the needs of the trained. Simulation gives caregivers an opportunity to manage stressful medical events in a risk-free environment, which allows healthcare providers to be involved in and manage the family's traditional education when it comes to caring and teaching families. When the literature on increasing the preparedness of the caregivers for care, and thus reducing the burden of care, no studies evaluating the simulation-based training for informal caregivers were found. This study was needed with the idea that simulation-based training, which is provided with a high fidelity of moulage, will help the caregiver to understand the burn care easily, to be ready for care and therefore to reduce the burden of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedStudy Start
First participant enrolled
March 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedAugust 26, 2022
August 1, 2022
1 year
August 12, 2020
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
caregiving burden
The caregiver burden score will be assessed by Burden Scale for Family Caregivers.
from first month until third month
Preparedness of care
The readiness of caregiving will be assessed at the time of acceptence and post-training education by Preparedness for Caregiving Scale.
First assessment at time of acceptance of the study -2 day after education
Secondary Outcomes (1)
Burn Patient Fallow Up
3 months
Study Arms (2)
standard discharge education
NO INTERVENTIONThe control group will receive only the standard discharge education.
standard discharge education+Simulation based education
EXPERIMENTALThe intervention group will receive standard discharge education and then simulation based education will be performed
Interventions
high fidelity simulation with moulage
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related Publications (11)
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.
PMID: 21900138BACKGROUNDDeshpande, 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.
BACKGROUNDEvgeniou 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.
PMID: 23088646BACKGROUNDFaydali, S., & Bayraktar, N. (2011). Yanıklı Hastaların ve Yakınlarının Taburculuk Sonrası Bilgi Düzeylerinin Belirlenmesi. Turkish Journal of Research & Development in Nursing, 13(1).
BACKGROUNDFletcher 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.
PMID: 24084304BACKGROUNDGrasel, E., Chiu, T., & Oliver, R. (2003). Development and validation of the Burden Scale for Family Caregivers. Toronto: Comprehensive Rehabilitation and Mental Health Services.
BACKGROUNDJutten 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.
PMID: 28827242BACKGROUNDSullivan-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.
PMID: 22222512BACKGROUNDTofil 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.
PMID: 24137039BACKGROUNDUlusoy 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.
PMID: 27323761BACKGROUNDZwicker, 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zahide Tuncbilek, Asst. Prof.
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessor will be masked in the clinical trial. One of the investigators will enter the data by giving "a" for control group and "b" for intervention group. So that, the outcome assessor will not have knowledge which group is exposed to intervention.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2020
First Posted
February 9, 2021
Study Start
March 13, 2021
Primary Completion
March 22, 2022
Study Completion
June 28, 2022
Last Updated
August 26, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share