BurnsNCT04745208
Simulation-Based Training on the Preparedness and Burden of Caregiver
A study testing Simulation based education in people with Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- Simulation based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2021to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation-Based Training on the Preparedness and Burden of Caregiver of Patients With Burns: A Randomised Controlled Study
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Simulation based education
- Keywords
- burn, simulation, burden of care, readiness for caregiving., caregiver
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based educationBehavioural
high fidelity simulation with moulage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Simulation based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
caregiving burden
The caregiver burden score will be assessed by Burden Scale for Family Caregivers.
Measured: 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.
Measured: First assessment at time of acceptance of the study -2 day after education
Secondary outcomes (1)
Burn Patient Fallow Up
Burn patients will be fallowed from through 3 months and complications, rehospitalizations number, etc. will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start13 Mar 2021
- Primary completion22 Mar 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sabri Karahan, Hacettepe University
- Investigators
- Zahide Tuncbilek, Asst. Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745208
- Sponsor's protocol ID
- KA-19021
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21900138Deshpande, 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.
PubMed 23088646Faydali, 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.
PubMed 24084304Grasel, 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.
PubMed 28827242Sullivan-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.
PubMed 22222512Tofil 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.
PubMed 24137039Ulusoy 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.
PubMed 27323761Zwicker, 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 at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Training on the Preparedness and Burden of Caregiver of Patients With Burns: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04745208
- Acronym / sponsor ID
- KA-19021
- Conditions
- Burns
- Keywords
- burn, simulation, burden of care, readiness for caregiving., caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| standard discharge education | No intervention | –The control group will receive only the standard discharge education. |
| standard discharge education+Simulation based education | Experimental | Behavioral: Simulation based educationThe intervention group will receive standard discharge education and then simulation based education will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation based educationhigh fidelity simulation with moulage | Behavioural | standard discharge education+Simulation based education |
Primary outcome
caregiving burden
Time frame: from first month until third month
The caregiver burden score will be assessed by Burden Scale for Family Caregivers.
Preparedness of care
Time frame: First assessment at time of acceptance of the study -2 day after education
The readiness of caregiving will be assessed at the time of acceptence and post-training education by Preparedness for Caregiving Scale.
1 secondary outcome
Burn Patient Fallow Up
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 21900138Cook 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.
- BackgroundDeshpande, 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: PubMed 23088646Evgeniou 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.
- BackgroundFaydali, S., & Bayraktar, N. (2011). Yanıklı Hastaların ve Yakınlarının Taburculuk Sonrası Bilgi Düzeylerinin Belirlenmesi. Turkish Journal of Research & Development in Nursing, 13(1).
- Background: PubMed 24084304Fletcher 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.
- BackgroundGrasel, E., Chiu, T., & Oliver, R. (2003). Development and validation of the Burden Scale for Family Caregivers. Toronto: Comprehensive Rehabilitation and Mental Health Services.
- Background: PubMed 28827242Jutten 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.
- Background: PubMed 22222512Sullivan-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.
- Background: PubMed 24137039Tofil 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.
- Background: PubMed 27323761Ulusoy 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.
- BackgroundZwicker, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahide Tuncbilek, Asst. Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based education in people with Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caregiving burden (time frame: from first month until third month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745208, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.