NCT04745208

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 12, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 12, 2020

Last Update Submit

August 25, 2022

Conditions

Keywords

burnsimulationburden of carereadiness for caregiving.caregiver

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 INTERVENTION

The control group will receive only the standard discharge education.

standard discharge education+Simulation based education

EXPERIMENTAL

The intervention group will receive standard discharge education and then simulation based education will be performed

Behavioral: Simulation based education

Interventions

high fidelity simulation with moulage

standard discharge education+Simulation based education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 21900138BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23088646BACKGROUND
  • Faydali, S., & Bayraktar, N. (2011). Yanıklı Hastaların ve Yakınlarının Taburculuk Sonrası Bilgi Düzeylerinin Belirlenmesi. Turkish Journal of Research & Development in Nursing, 13(1).

    BACKGROUND
  • 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.

    PMID: 24084304BACKGROUND
  • Grasel, E., Chiu, T., & Oliver, R. (2003). Development and validation of the Burden Scale for Family Caregivers. Toronto: Comprehensive Rehabilitation and Mental Health Services.

    BACKGROUND
  • 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.

    PMID: 28827242BACKGROUND
  • 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.

    PMID: 22222512BACKGROUND
  • 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.

    PMID: 24137039BACKGROUND
  • 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.

    PMID: 27323761BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Zahide Tuncbilek, Asst. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

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
Model Details: Simulation-based education will be performed after the standard discharge training with the intervention group. The control group will receive only the standard discharge education
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

Locations