(1) Objectives: the purpose of this study was to examine the effect of henna on pressure ulcer grade one in ICU patients. (2) Study design: In this clinical trial, 76 patients were divided randomly into two control and intervention groups. (3) Setting and conduct: the classification form of the International Pressure Ulcer Advisory Panel was used to identify grade one ulcers. Data was collected on the first day through demographic information questionnaire and Braden pressure ulcer risk assessment scale. An infrared thermometer was used to record local temperature of the ulcers on a daily basis. Assessments were made based on Pressure Ulcer Scale for Healing (PUSH tool) and the pressure ulcer area was examined per square centimeter on the first, fourth and seventh days. (4) The participants were eligible patients hospitalized in hospitals of Isfahan University of Medical Sciences. Inclusion criteria: No history of disease and skin irritation, any food and medicine allergies, non-addiction to drugs. Exclusion criteria: Unwillingness of patients or their families to participate in the study. (5) Interventions: pressure ulcer caring methods such as repositioning was performed by nurses for all patients at least every two hours. A mixture of henna and distilled water was applied topically in the intervention group. (6) The variables included pressure ulcer assessment according to Pressure Ulcer Scale for Healing (PUSH tool), local temperature of the ulcer and pressure ulcer area per cm2.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605167391N4
Registration date:2017-06-20, 1396/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Maryam Eghbali Babadi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7539
Email address
eghbali@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-25, 1395/11/06
Expected recruitment end date
2017-05-20, 1396/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Henna (Lawsonia Inermis) on Pressure Ulcer Grade One in ICU Patients
Public title
The effect of henna( lawsonia inermis) on pressure ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No history of disease and skin irritation, any food and medicine allergies; non-addiction to drugs. Exclusion criteria: Unwillingness of patients or their families to participate in the study.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Science
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.MUI.REC.1395.3.783
Health conditions studied
1
Description of health condition studied
Stage I decubitus ulcer
ICD-10 code
L89.0
ICD-10 code description
Stage I decubitus ulcer and pressure area
Primary outcomes
1
Description
pressure ulcer area
Timepoint
on the first, fourth and seventh days
Method of measurement
per square centimeter by meter
2
Description
local temperature of the ulcer
Timepoint
on the first, fourth and seventh days
Method of measurement
cantigrad by infrared thermometer
3
Description
Assessment of Ulcer
Timepoint
on the first, fourth and seventh days
Method of measurement
PUSH tool base on score of 0 to 17
Secondary outcomes
1
Description
allergic reaction to henna
Timepoint
Before intervention
Method of measurement
to test the allergic reaction to henna, a mixture of 1 g henna and 10 ml distilled water was applied on the inner part of the forearm to see an allergic reaction in 10 minutes
Intervention groups
1
Description
In the intervention group,pressure ulcer caring methods such as repositioning at least every two hours and keep the skin clean was performed by nurses.Then mixture of henna and distilled water was applied on the ulcer for 30 minutes .Then, the area was washed with lukewarm water and dried.
Category
Treatment - Other
2
Description
In the control group, pressure ulcer caring methods such as repositioning at least every two hours and keep the skin clean was performed by nurses.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra Hospital
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Street address
City
Isfahan
3
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Science
Full name of responsible person
Mahdi Nematbakhsh
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Eghbali Babadi
Full name of responsible person
Maryam
Position
Academic member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
+98 31 3669 9398
Email
eghbali@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Academic member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
+98 31 3669 9398
Email
eghbali@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Academic member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
+98 31 3669 9398
Email
eghbali@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)