The effect of acupressure on the level of the O2 saturation, exhaled carbon dioxide and physiological indexes in the brain contusion patients under mechanical ventilation.
The effect of acupressure on the level of the O2 saturation, exhaled carbon dioxide and physiological indexes in the brain contusion patients under mechanical ventilation
Design
Randomized clinical trial with control and intervention group, with parallel groups, without blindness, sample size= 64
Settings and conduct
ICU Section .
The researcher first meets the patients' companions and describes the research objectives. If they are satisfied and based on entry criteria, patients will be selected for participation in the study and will be randomly assigned to two groups of control and test Will divide.
Participants/Inclusion and exclusion criteria
Diagnosis of brain trauma (contusion)
Under mechanical ventilation
Intervention groups
Applying acupressure on p6 for 10 minutes at two times in the morning and afternoon for two consecutive days for the intervention group, in the control group, as in the intervention group, the pressure intervention on the false point will be done
The effect of acupressure on the level of the O2 saturation, exhaled carbon dioxide and physiological indexes in the brain contusion patients under mechanical ventilation.
Public title
Effect of acupressure on the level of the o2 saturation,exhaled carbon dioxide and physiological indexes in the brain traumatic (contusion) patients under mechanical ventilation.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Brain contusion admitted to the intensive care unit
Exclusion criteria:
The patient does not cooperate
The patient's family does not consent
Change the treatment strategy
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:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Based on their inclusion criteria, they are selected for inclusion in the study and then divided into control and test groups based on the random allocation rule. In this method, according to the sample size of the dual card (red and blue) with the same number and total volume of the sample in the pot, then eligible individuals randomly drop one of the cards from the pot and, according to the definition of the researcher, enter one of the research groups will be
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 Shahrekord University of Medical Sciences
Street address
Kashani street-NerveCenter of Shahrekord Univercity of Medical Scieences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-04-20, 1398/01/31
Ethics committee reference number
IR.SKUMS.REC.1398.026
Health conditions studied
1
Description of health condition studied
Brain trauma
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
effect acupressure of index physiology
Timepoint
Before the intervention immediately after half an hour and an hour later
Method of measurement
Monitoring
2
Description
Exhaled carbon dioxide
Timepoint
Before the intervention immediately after half an hour and an hour later
Method of measurement
Capnograph
3
Description
Percent saturation of oxygen
Timepoint
Before the intervention immediately after half an hour and an hour later
Method of measurement
Pulse oximeters
Secondary outcomes
1
Description
Exhaled carbon dioxide
Timepoint
Before the intervention immediately after half an hour and an hour later
Method of measurement
capnograghy
Intervention groups
1
Description
Intervention group: Pressure at point p6 for ten minutes in the morning and evening for two consecutive days
Category
N/A
2
Description
Control group:Exercise pressure at the false point for ten minutes in the morning and afternoon for two consecutive days
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sharekord kashani Hospital
Full name of responsible person
Azam Moslehi
Street address
Parastar street-Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3424 4340
Email
Rahamoslehi25@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Kashani street-Nervercenter of Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 1334 9506
Email
Pajoohesh@skums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahreyar Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rahmatiyeh-Univercity of Medical Scieences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 1334 2414
Email
Sh-salehitali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriyar Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord medical university
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 1334 2414
Email
sh-salehitali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Azam Moslehi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 1334 2414
Email
rahamoslehi25@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