Protocol summary

Summary
Objective: determination of effect of deep-slow and regular breathing on pain intensity after chest tube removal in patients underwent Coronary hospitalized in Imam Ali-Design: randomized controlled clinical trial. Setting and conduct: required sample size is 140 patients. Eligible patients will be allocated to one of the two groups of deep-slow and regular breathing and control group by randomization-Inclusion criteria include Consent to participate in the study, age between 25 to 65 years, stable vital signs, The ability to speak and understand the language, conscious of the place, time and person ,No take sedative and analgesic four hours before pulling the chest tube, No history of diabetes, No respiratory infection or infection chest tube, No history of drug addiction, No history of previous chest surgery had a chest tube lateral or bilateral, having at least one chest-Exclusion criteria include Patients who do not continue cooperation until the end of intervention, critically ill patient during the study; death the patient's-Interventions: In order to gather data in both group pain intensity using a visual analog scale, two minutes after dressing removal chest tube will be assessed and after the intervention group be asked, deep-slow and regular breathing for 15 minutes and Control group will receive routine cares. Again pain intensity in both groups using a VAS, 15 minutes after removal of the chest tube, will be assessed by the investigator-The main outcome variables: pain intensity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021932650N1
Registration date: 2017-04-05, 1396/01/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Bahareh Dehghany
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 1081
Email address
dehghanyb95@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
determination of effect of deep-slow and regular breathing on pain intensity after chest tube removal in patients underwent Coronary Artery Bypass Graft (CABG) surgery
Public title
The effect of deep-slow and regular breathing on pain intensity after chest tube removal in patients underwent Coronary Artery Bypass Graft (CABG) surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : age between 25 to 65 years; stable vital signs; The ability to speak and understand the language; conscious of the place, time and person; No take sedative and analgesic four hours before pulling the chest tube; No history of diabetes; No respiratory infection or infection chest tube; No history of drug addiction; No history of previous chest surgery had a chest tube lateral or bilateral; having at least one chest. exclusion criteria : Patients who do not continue cooperation until the end of intervention; critically ill patient during the study; death the patient's.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
kermanshah
Postal code
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
kums.rec.1395.633

Health conditions studied

1

Description of health condition studied
coronary surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery

2

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

Primary outcomes

1

Description
pain intensity
Timepoint
Minute 2 and 15 after removal chest tube
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: two minutes after the removal of chest tube , to measure pain intensity, visual analog scale will be given to complete. Then they are asked, 15 minutes of deep, slow and regular breathing, and again to complete the visual analog scale
Category
Other

2

Description
Control group: two minutes after the removal of chest tube , to measure pain intensity, visual analog scale will be given to complete. 15 minutes later, without any intervention (usual care only) again to will be complete the visual analog scale
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital of Kermanshah
Full name of responsible person
Jahangir Rezaie
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshty street, Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kermanshah 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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Jahangir Rezaie
Position
master of Nursing Education-Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer street
City
Kermanshah
Postal code
Phone
+98 83 3826 1081
Fax
Email
dehghanyb95@gmail.com , j-rezaie@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Jahangir Rezaie
Position
Masters of Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street
City
Kermanshah
Postal code
Phone
+98 83 3826 1081
Fax
Email
dehghanyb95@gmail.com , j-rezaie@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Jahangir Rezaie
Position
master of Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street
City
kermanshah
Postal code
Phone
+98 83 3826 1081
Fax
Email
dehghanyb95@gmail.com , j-rezaie@kums.ac.ir
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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