The aim of this study is to determine the effect of touch on patient's agitation under mechanical ventilation.
Inclusion criteria: Alert patient between 30- 60 years old with acute respiratory problems and under mechanical ventilation with agitation, which assessed with Richmond criteria. If the level of agitation was, +2 - +4 this case inter to study.
Exclusion criteria of study: If a patient feels comfortable after primary nursing care, and agitation behavior is controlled, or by any reason the patient is separated from mechanical ventilation the patient is excluded from study.
The society of under study: Our samples include of patients, which hospitalized in ward of intensive care unit in Tehran Day hospital, that have inter criteria situation.
Sample size: Will be assessing 30 patients.
Time and type of intervention and primary consequence: Application of intervention is in two forms that consequences of them allocation in randomize. First intervention: With standing beside the patient and use of touch in form of therapist's palm hand contact to behind the patient's wrist (So that therapist's fingers become close in the internal part of the patient's forearm) and without pressure use, touch will take for five minutes. Other intervention: Nurse only stands beside the patient for five minutes, without touching him. Patient's agitation scores evaluate and record before and after each intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104276318N1
Registration date:2011-07-11, 1390/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-11, 1390/04/20
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2011-04-25, 1390/02/05
Expected recruitment end date
2011-07-27, 1390/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of touch on patients’ agitation under mechanical ventilation
Public title
Effect of touch on patients’ agitation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Alert patient between 30- 60 years old with acute respiratory problems and under mechanical ventilation with agitation, which assessed with Richmond criteria. If the level of agitation was, +2 - +4 this case inter to study.
Exclusion criteria of study: If a patient feels comfortable after primary nursing care, and agitation behavior is controlled, or by any reason the patient is separated from mechanical ventilation the patient is excluded from study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Boulvar Basij, Semnan
City
Semnan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
89.49280
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Primary outcomes
1
Description
Agitation
Timepoint
5 min
Method of measurement
The tool of agitation assessment is Richmond, which according to the mood and amount of violence, type of limbs purposeful movements and the dangerous actions existence evaluate the patient alertness and response to commands and determine the level of patient agitation.
Secondary outcomes
1
Description
Agitation
Timepoint
5 min
Method of measurement
The tool of agitation assessment is Richmond, which according to the mood and amount of violence, type of limbs purposeful movements and the dangerous actions existence evaluate the patient alertness and response to commands and determine the level of patient agitation.
Intervention groups
1
Description
First intervention: With standing beside the patient and use of touch in form of therapist's palm hand contact to behind the patient's wrist (So that therapist's fingers become close in the internal part of the patient's forearm) and without pressure use, touch will take for five minutes.
Category
Other
2
Description
Other intervention: Nurse only stands beside the patient for five minutes, without touching him. Patient's agitation scores evaluate and record before and after each intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Day Hospital
Full name of responsible person
Nobahar Monir
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ghorbani
Street address
Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nobahar Monir
Position
Academic member
Other areas of specialty/work
Street address
Nursing Faculty, University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
Nobahar43@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nobahar Monir
Position
Instructor
Other areas of specialty/work
Street address
Nursing Faculty, University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
Email
Nobahar43@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nobahar Monir
Position
Instructor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
Nobahar43@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)