This research with the goal of study on effectiveness of Henna (Lawsonia inermis) on prevention of pressure ulcer on hospitalized patients in Intensive Care Units will be done. Inclusion Criteria: No having pressure ulcer on recruitment; to be hospitalized in ICU; no diabetes;
Exclusion Criteria: No desire to continue the study; death
First 80 hospitalized patients in ICU based on convenience sampling method will be selected, then all of them with closed envelopes method randomly will be allocated into two trial and control groups.
Interventions are as follows:
In Trial group, beside of massage of sacrum, at one time Henna is placed 15 cm on sacrum and after 30 minutes it will be washed. Then sacrum will be assessed for pressure ulcer signs (e.g. local temperature) at 10 o’clock every day up to one week.
In control group only routine nursing care (massage with no material) will be done. Then sacrum will be assessed for pressure ulcer signs (e.g. local temperature) at 10 o’clock every day up to one week.
In this study the primary outcome will be incidence of bed sore signs (e.g. local temperature) and secondary outcome will be pressure ulcer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070323035N1
Registration date:2015-10-31, 1394/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-31, 1394/08/09
Registrant information
Name
Fatemeh Ahmadian
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3645
Email address
f.ahmadian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-06-25, 1394/04/04
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Henna (Lawsonia Inermis) on prevention of pressure ulcer
Public title
Effectiveness of Henna (Lawsonia Inermis) on prevention of pressure ulcer on hospitalized patients in Intensive Care Units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria : No having pressure ulcer on recruitment; to be hospitalized in ICU; no diabetes;
Exclusion Criteria : No desire to continue the study; death
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Postal code
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.ARAKMU.REC.1394,36
Health conditions studied
1
Description of health condition studied
pressure ulcer
ICD-10 code
l89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Sacrum local tempereture
Timepoint
every day at 10 o’clock up to one week
Method of measurement
Skin Thermometer
Secondary outcomes
1
Description
Pressure Ulcer
Timepoint
At the first day of study and after One week
Method of measurement
Braden Scale
Intervention groups
1
Description
Intervention Group:
In intervention group, beside of massage of sacrum, at one time Henna is placed 15 cm on sacrum and after 30 minutes it will be washed. Then sacrum will be assessed for pressure ulcer signs (e.g. local temperature) at 10 o’clock every day up to one week.
Category
Prevention
2
Description
Control Group:
In control group only routine nursing care (massage with no material) will be done. Then sacrum will be assessed for pressure ulcer signs (e.g. local temperature) at 10 o’clock every day up to one week.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Haspital
Full name of responsible person
Fatemeh Ahmadian
Street address
Alzahra Haspital, Sofeh Bl, Kheshvary High way
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadian
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadian
Position
Nurse
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
ahmadian.2024@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadian
Position
Nurse
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
ahmadian.2024@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadian
Position
Nurse
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
ahmadian.2024@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)