The effect of sheep felt mattress on the prevention of pressure ulcers in patients
Design
A control trial with a control group, with a parallel, three-blind, randomized group, on 116 patients, will use permutation block randomization.
Settings and conduct
The study will be performed on patients admitted to the wards of Allameh Bohlool Gonabadi Hospital who are eligible to enter the study.
Participants/Inclusion and exclusion criteria
Entry requirements:
Score of 13 or higher on the Braden scale
Informed consent of the patient or his / her guardian
No bed sores at the time of admission to the hospital
No uncontrolled diabetes
No entry conditions:
Death of patient
Discharge before one week after the start of the study
Occurrence of any allergy to felt
Intervention groups
Intervention group: Before the intervention, the skin health of patients in the pressure areas will be examined and all mechanical, chemical and bacterial factors that cause pressure ulcers will be determined. In addition to changing the position every 2 hours, along with the wavy mattress, a felt mat (made by Devinfeltco) with cotton sheets will be used. The intervention lasts for at least a week and the sites prone to pressure ulcers will be examined daily by the Braden scale and the data will be recorded.
Control group: Before the intervention, the skin health of patients in the pressure areas will be examined and all mechanical, chemical and bacterial factors that cause pressure ulcers will be determined. But patients will only receive routine care (changing position every 2 hours and a wavy mattress with a cotton cover).
Main outcome variables
bed sores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043968N3
Registration date:2022-05-11, 1401/02/21
Registration timing:registered_while_recruiting
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Maryam Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5652 5792
Email address
moradi.mf69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sheep felt mattress on the prevention of pressure ulcers in patients admitted to the wards of Allameh Bohlool Gonabadi Hospital
Public title
The effect of sheep felt mattress on the prevention of pressure ulcers in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Score of 13 or higher on the Braden scale
Informed consent of the patient or his / her guardian
No bed sores at the time of admission to the hospital
No uncontrolled diabetes
Exclusion criteria:
Death of the patient
Discharge before one week after the start of the study
Occurrence of any allergy to felt
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected using available sampling method and then assigned to the control and experimental groups by permutation block Randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the evaluator, patient and analyst will be blinded and will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad university of medical scinces, next to the Asian Road, Gonabad city, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
IR.GMU.REC.1400.184
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prevention of bed sore
Timepoint
Before intervention and one week after intervention
Method of measurement
the Bets Jensen questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the intervention, the skin health of patients in the pressure areas will be examined and all mechanical, chemical and bacterial factors that cause pressure ulcers will be determined. In addition to changing the position every 2 hours, along with the wavy mattress, a felt mat (made by Devinfeltco) with cotton sheets will be used. The intervention lasts for at least a week and the sites prone to pressure ulcers will be examined daily by the Braden scale and the data will be recorded.
Category
Prevention
2
Description
Control group: Before the intervention, the skin health of patients in the pressure areas will be examined and all mechanical, chemical and bacterial factors that cause pressure ulcers will be determined. But patients will only receive routine care (changing position every 2 hours and a wavy mattress with a cotton cover).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Maryam Moradi
Street address
Allameh Behoul Gonabadi Hospital; Parstar blvd; Saadi street, Gonabad city, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6832
Email
moradi.mf69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Research Center for Social Determinants of Health, Gonabad University of Medical Sciences, Gonabad university of medical scinces, next to the Asian Road, Gonabad city, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Gonabad university of medical scinces, next to the Asian Road, Gonabad city, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Gonabad university of medical scinces, next to the Asian Road, Gonabad city, Razavi Khorasan, Iran
City
Instructor
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Gonabad university of medical scinces, next to the Asian Road, Gonabad city, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available