The effect of Shiatsu massage on agitated and vital signs of patients undergoing mechanical ventilation
Design
Clinical trial with control group, with parallel groups, Single blinded, randomized
Settings and conduct
In this study will be selected 68 patients hospitalized in the intensive care unit of valiasr hospital in arak city and with random blocks will be divided to two groups of experimental and control. Alternate shiatsu will be performed for 5 minutes massage and 2-minute rest to 20 minutes by the intervention group, control group during this period will receive touch without pressure for 20 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 30 to 60 years
Level of consciousness higher than 7 on the Glasgow standard
Restlessness behavior according to Richmond criteria in the range of 2+ to 4 +
exclusion criteria:
Any life-threatening emergency situation
skin diseases such as ulcers and infections of hand
Intervention groups
Intervention group: Alternate shiatsu will be performed for 5 minutes massage and 2-minute rest to 20 minutes.
Control group: Touch without pressure will be done for 20 minutes.
Main outcome variables
Agitation, Vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N9
Registration date:2020-01-17, 1398/10/27
Registration timing:registered_while_recruiting
Last update:2020-01-17, 1398/10/27
Update count:0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-11, 1398/07/19
Expected recruitment end date
2020-04-07, 1399/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Shiatsu massage on restlessness and vital signs of patients undergoing mechanical ventilation
Public title
The effect of Shiatsu massage on agitated and vital signs of patients undergoing mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 30 to 60 years
Level of consciousness higher than 7 on the Glasgow standard
Restlessness behavior according to Richmond criteria in the range of 2 + to 4 +
Exclusion criteria:
Paralyzed hands
Spinal cord injury
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate the patients randomly into two groups of treatment and control, at first 22 blocks of 4 with C and T letters (The letters indicate the intervention and control groups) are created in each 2 patients are belonged to the intervention group and 2 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 68 letters. Each letter will be placed in a sealed packet according to the obtained sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
It should be noted that the nurse who will measure the vital signs and the patient's restlessness level through the Richmond Instrument will be unaware of the type of intervention being performed, so it will be a single blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.ARAKMU.REC.1398.196
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R46
ICD-10 code description
Symptoms and signs involving appearance and behavior
Primary outcomes
1
Description
Agitation
Timepoint
Before and after the intervention
Method of measurement
Richmond agitation scale
2
Description
Systolic blood pressure
Timepoint
Before and after the intervention
Method of measurement
Digital pressure indicator gauge
3
Description
Dyastolic blood pressure
Timepoint
Before and after the intervention
Method of measurement
Digital pressure indicator gauge
4
Description
Pulse rate
Timepoint
Before and after the intervention
Method of measurement
Radial Pulse
5
Description
Respiratory rate
Timepoint
Before and after the intervention
Method of measurement
Observation chest in a minute
6
Description
Temperatures
Timepoint
Before and after the intervention
Method of measurement
Thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group at one time alternate shiatsu on the Hugo points will be performed for 5 minutes massage and 2-minute rest to 20 minutes. Vital signs and severity of agitation before and after the intervention, using the Richmond score will determined.
Category
N/A
2
Description
Control group: Patients in the control group do not receive any Shiatsu massage intervention on the part of the researcher. In this group, only touch without pressure will be done for 20 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital Arak
Full name of responsible person
Masoumeh Garshasbi
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3503
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Garshasbi
Position
MSc student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School Of Nursing And Midwifery, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
garshasbimasoume@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor Faculty Of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Garshasbi
Position
MSc student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
garshasbimasoume@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