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Investigating the combined effect of reflex massage and respiratory relaxation on pain following chest tube removal in heart surgery patients

Protocol summary

Study aim
Determining the combined effect of reflex massage and respiratory relaxation on pain following chest tube removal in heart surgery patients
Design
A clinical trial with a control group and parallel groups, double-blind, randomized, on 140 patients, in an accessible method based on the goal and as a block randomization.
Settings and conduct
Determination of groups, invitation to participate in the study, an explanatory meeting for each person, obtaining informed consent, statistical population: all heart surgery patients with pleural chest tube. Research environment: special care department of Shahid Beheshti Hospital, Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study, age 18 or older, having a pleural chest tube, awareness of time, place and person, ability to understand the visual scale of pain, no severe vision and hearing impairment, no neuropathy and sensory disorders caused by diabetes. Not addicted to drugs and alcohol. Exclusion criteria: unwillingness to continue participating in the study, being connected to a ventilator, receiving narcotic pain medication for less than 4 hours
Intervention groups
1- Control group: removal of the chest tube by routine method 2- Respiratory relaxation group: removal of the chest tube using respiratory relaxation methods 3- Foot reflex massage group: to reduce pain from massage according to the standard 4- Combination group of respiratory relaxation and massage Reflexive: pain control by combining respiratory relaxation + reflex foot massager together
Main outcome variables
intensity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131228015965N22
Registration date: 2023-11-28, 1402/09/07
Registration timing: retrospective

Last update: 2023-11-28, 1402/09/07
Update count: 0
Registration date
2023-11-28, 1402/09/07
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-15, 1402/01/26
Expected recruitment end date
2023-10-18, 1402/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the combined effect of reflex massage and respiratory relaxation on pain following chest tube removal in heart surgery patients
Public title
Evaluation of the combined effects of two methods of reflexology massage and respiratory relaxation on pain following chest tube removal in heart surgery patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study Age 18 or older Patients who only have a pleural chest tube Awareness of time, place and person The ability to understand the visual scale of pain Absence of severe vision and hearing impairment Not having neuropathy and sensory disorders caused by diabetes Not addicted to drugs and alcohol
Exclusion criteria:
Unwillingness to continue participating in the study Being connected to a ventilator Receive narcotic pain medication less than 4 hours
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a randomized clinical trial with the participation of 140 patients undergoing open heart surgery, using the block randomization method (blocks of four), who were assigned to four intervention and control groups of 35 patients by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is This research is a randomized clinical trial with a control group and a blind side; in which the evaluator of pain intensity will be unaware of the type of intervention.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Boulevard, Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.RUMS.REC.1401.236

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
intensity of pain
Timepoint
Before, immediately, 15 minutes after the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, chest tube removal will be done in a routine way.
Category
Other

2

Description
Intervention group 1: Respiratory relaxation group, in which 5 minutes before the removal of the chest tube, slow and deep breathing exercises will be performed, in such a way that the patient closes his eyes, slow and deep breath through the nose and slow exhalation. will do with bud lips.
Category
Other

3

Description
Intervention group 2: Foot reflex massage group, in which the center of the anterior third of the patient's left foot between the arch of the foot and the toes, a knuckle under the second toe and the thumb moments before the chest tube exits for ten minutes in a circular manner (like crushing a sugar cube with your thumb) will be massaged with gentle pressure.
Category
Other

4

Description
Intervention group 3: The combination group of respiratory relaxation and reflex massage, which in this group will be performed together to control pain during chest tube removal before performing the procedure of respiratory relaxation + foot reflex massage.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Shiraz
Full name of responsible person
Majid Kazemi
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
maj_kaz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
rvazirinejad@yahoo.co.uk
Web page address
http://rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
maj_kaz@yahoo.com
Web page address
http://rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
maj_kaz@yahoo.com
Web page address
http://rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
maj_kaz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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