Protocol summary

Summary
This clinical trial is a quasi-experimental pre-test - post-test,In which to evaluate the effectiveness of Acupressure and Cryotherapy of pain in elderly people leaving hospital chest drainage tube will be Martyr Rajai Alborz. Samples were selected based on research and then explain the nature of the research and obtaining written consent from the samples will be carried out, The samples were randomly selected according to extraction by patients of the bag. A sample size of 150 is considered.The degree of pain in each group before the intervention by the VAS assessment of pain (VAS) to be measured.Then, immediately after and 30 minutes after the departure of chest tube drainage of these tools will be used to measure pain.The Acupressure at Hugo (LI4) Pressure a person will be trained. Hugo point (LI4: Back of the hand second metacarpal bone 1 and 2 and the radial pressure is 4 seconds and 2 seconds of rest in bilateral and this will be repeated 10 times per minute. Acupressure treatment for 30 minutes (20 minutes before to 10 minutes after extubation) will apply. Cryotherapy group of 3 closed cooling gel for 20 minutes around the chest tube drainage (pre-extubation) will be used and The control group will receive only routine care. Inclusion criteria: having no cognitive impairment and psychiatric using AMT, Having a chest tube into the pleural area, No allergy to the cold in Cryotherapy. Non sedatives 12 hours before the intervention. Having a BMI in the normal range,The lack of any scarring and deformity at LI4, Lack of housing for 4 hours before the intervention, Lack of serious illness, exclusion criteria included: Patients connected to a mechanical ventilator. Sudden change in the patient's condition during the intervention (such as Angina).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070623100N1
Registration date: 2015-08-31, 1394/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Sakineh Hajizadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
hajizadeh.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cryotherapy of pain compared to Acupressure and drainage chest tube removal in the Elderly
Public title
Efficacy of Acupressure and Cryotherapy on Pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Lack of cognitive and mental disorders using AMT and earn a minimum score of 7 ؛ Having a chest tube into the pleural area after open heart surgery؛ Cryotherapy in the group of patients who do not have allergy to the cold؛ The intervention did not receive sedation 12 hours before؛ BMI is normal؛ The lack of any scratches؛ scars and disfigurement at LI4؛ Lack of housing for 4 hours before the intervention؛ Lack of serious diseases such as diabetes؛ neuropathy and disorders such as Raynaud disease and burger؛ Exclusion criteria: patients connected to mechanical ventilation؛ Patients with severe visual impairment؛ severe hearing loss patients؛ Sudden change in the patient's condition during the intervention and pain in other parts of the pain at the site of drainage pipes to affect (such as angina)؛ Patients who do not contribute to the end of intervention.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Iran University of Medical Sciences
Street address
Floor 5, Headquarters,Iran University of Medical Sciences, Between Sheikh Fazlollah & Chamran, Hemat Express way
City
Tehran
Postal code
1449614535
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394.9311580004

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52, R52.0
ICD-10 code description
Pain, not elsewhere classified, Acute pain

Primary outcomes

1

Description
Pain
Timepoint
20 minutes before,Immediately and 15 minutes after intervention
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Cryotherapy in cooling gel for 20 minutes before leaving drainage chest tubes will be placed. The study of cold gel cooling through 3 depending on size cm 10 x8 around drainage pipes will be used. Acupressure intervention in the 4 seconds and 2 seconds Hugo pressure at rest is considered This process will be repeated 10 times per minute. This will be done bilaterally to 30 minutes. When verifying the authenticity of the client at that point feeling of warmth, heaviness, swelling, or is numb. Push both hands simultaneously in 20 minutes to 10 minutes before leaving drainage tube drainage tube will be done immediately.
Category
Other

2

Description
In the control group only standard routine care after open heart surgery will be done.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Rajai Hospital Alborz
Full name of responsible person
Sakine Hajizadeh-Geriatric Nursing Graduate Student
Street address
Martyr Rajai Hospital, Martyr Rajai ST, Martyr Beheshti ST, Alborz
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Depty Research of Iran University of Medical Sciences
Full name of responsible person
Motavallian Doctor
Street address
Floor 5, Center Chief, Iran University of Medical Sciences, Between Chmran & Sheikh Fazlollah, Hemat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Depty Research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Farideh Bastani
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery of Iran, Opposite the Khatam Hospital, Higher than Mirdamad, Vanak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 321 2311
Fax
Email
faridehbastani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sakine Hajizadeh
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery of Iran, Opposite the Khatam Hospital, Higher than Mirdamad, VANAK, Tehran, Iran
City
Tehran
Postal code
Phone
+98 919 011 2795
Fax
Email
sakinehaji@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sakine Hajizadeh
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery of Iran, Opposite the Khatam Hospital, Higher than Mirdamad, Vanak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 919 011 2795
Fax
Email
sakinehaji@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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