The comparison of the effect of massage and elevation on decreasing hand edema of patients of intensive care units of Kerman city medical sciences university
Objective: The edema is an important complication of bed rest in intensive care units (ICU). The aim of this study is comparison of effect of massage and elevation on decreasing hand edema of these patients.
Design: It is a randomize and double blind study.
Setting and conduct: In this study, there are 35 patients of ICU with inclusion criterias that include: having pitting edema at least 2 mm or +1 grade according pitting scale ; comatose patients with maximum level 8 of Glasgow Coma Scale (GCS). Exclusion criterias include: having subclavian catheter; edema after mastectomy; heart failure; hepatic or renal disease; present of thromboembolism, infection and wound or fracture and amputation in one or both of hands.
Intervention: In this study, before the intervention, the researcher measure and record circumference of wrist and middle of arm by a meter (milimeter), then one of the hand is placed in the Intermittent Pneumatic Compression (IPC) device by a nurse and receive massage with 50 mmHg. The other hand is elevated by a slope board with 30 degree for 30 minutes. After this time, the researcher measure circumference of hand again for checking the changes in size to compare which method is more effective. This intervention perform two times in a day between 8-12 AM and 4-7 PM, in whole five sessions for every patient.
main outcome: Hand edema
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307155426N6
Registration date:2013-08-03, 1392/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of massage and elevation on decreasing hand edema of patients of intensive care units of Kerman city medical sciences university
Public title
The comparison of the effect of massage and elevation on decreasing hand edema of patients of intensive care units of Kerman city medical sciences university
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criterias: having pitting edema at least 2 mm or +1 grade according pitting scale ; comatose patients with maximum level 8 of Glasgow Coma Scale (GCS).
Exclusion criterias include: having subclavian catheter; edema after mastectomy; heart failure; hepatic or renal disease; present of thromboembolism, infection and wound or fracture and amputation in one or both of hands.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
kerman
Postal code
Approval date
2013-07-20, 1392/04/29
Ethics committee reference number
179/92/کا
Health conditions studied
1
Description of health condition studied
Edema
ICD-10 code
E43
ICD-10 code description
Unspecified severe protein-energy malnutrition
Primary outcomes
1
Description
Hand edema
Timepoint
Immediately before and after every intervention
Method of measurement
With meter and According to milimeter
Secondary outcomes
1
Description
central venous pressure
Timepoint
immediately before and after every intervention
Method of measurement
with central venous pressure ruler according to CmH2o
Intervention groups
1
Description
Intervention one: The researcher measure circumference of wrist and middle of arm by a meter (milimeter), then the hand is elevated by a slope board with 30 degree for 30 minutes. After this time, the researcher measure circumference of hand again for checking the changes in size.
Category
Prevention
2
Description
Intervention two: The researcher measure and record circumference of wrist and middle of arm by a meter (milimeter), then the hand is placed in the Intermittent Pneumatic Compression (IPC) device by a nurse and receive massage with 50 mmHg. After this time, the researcher measure circumference of hand again for checking the changes in size.