Protocol summary

Study aim
The study of the effect of duration of foot massage time on physiological indices of cerebrovascular accident patients with a lack of consciousness hospitalized in intensive care units
Design
A clinical trial with two parallel intervention groups: one-blind, randomized, quadruple blocks with 64 samples
Settings and conduct
This study is performed on patients with cerebrovascular accidents with decreased consciousness in the intensive care units of Imam Reza, Farabi, and Taleghani Hospitals of Kermanshah University of Medical Sciences. In the first intervention group 5 minutes, and in the second intervention group 10 minutes of massage of the foot will be carried out. Then, changes in the physiological indices are compared in two groups. The study is one-blind and as for lack of consciousness in participant patients in the study, without knowing the duration of massage time which is done for them, are divided into two groups of 5 and 10 minutes massage.
Participants/Inclusion and exclusion criteria
Entry requirements include: admission in the intensive care unit due to stroke, passing 48 hours after the initial admission, GCS score less than 15, passing at least 6 hours from receiving opiate and sedation medications; No entry conditions include: suffering from coagulation and vascular disorders in the legs, diabetes and dysrrhythmia, fractures and /or amputations in the lower extremities, having wounds, infection or skin disease, receiving drugs that affect blood pressure and heart rate
Intervention groups
In the first intervention group, foot massage is performed for 5 minutes and in the second intervention group, the foot massage is performed for 10 minutes.
Main outcome variables
Changes in physiological indices of patients with cerebrovascular accidents by decreasing the level of consciousness admitted to the intensive care unit regarding the duration of massage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180110038292N1
Registration date: 2018-05-06, 1397/02/16
Registration timing: registered_while_recruiting

Last update: 2018-05-06, 1397/02/16
Update count: 0
Registration date
2018-05-06, 1397/02/16
Registrant information
Name
Sara Poorshadan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6301
Email address
s.poorshadan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of duration of foot massage time on physiological indices of cerebrovascular accident patients with a lack of consciousness hospitalized in intensive care units
Public title
The effect of duration of foot massage time on physiological indices
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Admission in the intensive care unit due to stroke Pass 48 hours after patients hospitalization passing at least 6 hours from receiving opiate and sedation medications GCS score less than 15
Exclusion criteria:
Coagulation and vascular disorders in the legs, diabetes and dysrhythmia Fracture or amputation lower limb Having sore, infection or skin disease in the legs Receiving drugs that affect blood pressure and heart rate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization algorithm is performed using Smith's method. By using randomized blocks method (four blocks of letters A and B), eligible samples are assigned to two intervention groups.The randomization tool consists of some cards which have a combinations of two letters A and two letters B. These combinations are then randomly selected each time to determine how the four samples are placed in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
As for lack of consciousness in participant patients in the study, without knowing the duration of massage time which is done for them, are divided into two groups of 5 and 10 minutes massage.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
IR.KUMS.REC.1396.652

Health conditions studied

1

Description of health condition studied
Patients with cerebrovascular accidents and with decreased consciousness
ICD-10 code
VI
ICD-10 code description
Diseases of the nervous system

Primary outcomes

1

Description
Changes in physiological indices of patients with cerebrovascular accidents and decreased consciousness
Timepoint
2 minutes before the massage, 1 minute after the massage, 5 minutes after the massage
Method of measurement
The monitor used in Intensive Care Unit and a mercury thermometer

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: cerebrovascular accident patients with a lack of consciousness hospitalized in intensive care unit receives foot massage for 5 minutes.
Category
Other

2

Description
The second intervention group: cerebrovascular accident patients with a lack of consciousness hospitalized in intensive care unit receives foot massage for 10 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ali Soroush
Street address
Sorkhe Lyzheh Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
s.poorshadan@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Jalal Shakeri
Street address
Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 0700
Email
s.poorshadan@gmail.com

3

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Khosrow Farhadi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7989
Email
s.poorshadan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
s.poorshadan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Poorshadan
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 71, 221 Ave, Gozarname Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714689849
Phone
+98 83 3427 6301
Fax
Email
s.poorshadan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Poorshadan
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 71, 221 Ave, Gozarname Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714689849
Phone
+98 83 3427 6301
Fax
Email
s.poorshadan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Poorshadan
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 71, 221 Ave, Gozarname Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714689849
Phone
+98 83 3427 6301
Fax
Email
s.poorshadan@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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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