Objective: The aim of this study is to evaluate the effect of massage on pain intensity in patients with change of position. Design: This study is a randomized clinical trial with two groups before -after design. Setting and conduct: This study will be conducted with participation of 80 patients with decreased level of consciousness. Each group consisted of 40 peoples. Inclusion criteria: age between 18-60 years old; ability to respond to painful stimulation; having pain during change positions; doesn’t have diabetes, DVT, alcohol abuse, drug addiction, and skin problems. Exclusion criteria: increase level of consciousness; starting continuous infusion of sedative and analgesic agents; the occurrence of a serious event for the patient. Intervention: subjects will be selected by random sampling method and will be divided into two groups: a routine care group, and foot massage group. In the both groups, immediately after changed position, the pain intensity of the patients will be measured by using of observational pain assessment tool, and then 20 minutes before change position massage techniques will be applied. Massage will be done with slow movements of the ankle to the bottom, again, after second change of position, the pain intensity will be measured right after and 10 minutes after the massage. Control group will not receive any treatment. Main outcome measure: The main outcome will be the pain severity due to change of position of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121031327N1
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Zahra Veladati
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
z.veladati@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage on pain severity in unconscious patients during change position in intensive care unit
Public title
The effect of massage on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-60 years old; patients with a decreased level of consciousness by GCS between 5 and 8, that unable to verbal and non-verbal communication; the patients didn’t use any muscle relaxant drugs; at least for 24 hours unable to express their pain; ability to respond to painful stimulation; having pain during change positions; doesn’t have diabetes, DVT, alcohol abuse, drug addiction, and skin problems. Exclusion criteria: increase level of consciousness; starting continuous infusion of sedative and analgesic agents; the occurrence of a serious event for the patient.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Science
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Postal code
009881338380717
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.UMSHA.REC.1395.218
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
pain
Timepoint
Before intervention. Immediately after the intervention. Ten minutes after intervention
Method of measurement
Critical Care Pain Observation Tool (CPOT)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, foot massage will be done from the ankle to the bottom for each patient for 20 minutes before changing position.
Category
Prevention
2
Description
The control group will not receive any treatments.