Protocol summary

Summary
objectives: To explore the effect of massage therapy on pain following midsternotomy in the patients after off-pump coronary artery bypass grafting surgery. Study design: A double-blind randomized clinical trial, Methods: (a) participants: inclusion criteria:all patients undergoing elective coronary artery bypass graft in the Afshar cardiovascular research center of Yazd (50 patients); exclusion criteria: patients with chest pain caused by trauma; patients with a previous history of cardiac surgery; patients with chronic pain syndrome; patients with prolonged bleeding during hospital stay (more than 200 cc per hour); patients who had psychiatric disorders; patients who didn't want to continue participating in the study. sample size (50= intervention group: 25, control group:25), (b) intervention: in this study, the control group receive usual medications and cares without any additional intervention; but in intervention group: Four sessions of chest massage therapy by physiotherapist in the days 2 to 5 after surgery (before discharging patients from the hospital) and 12 sessions of massage therapy,three times a week, at the one-month follow-up (every session lasted for 15 minutes)- chest massage therapy techniques: (positioning and postural drainage, chest tapotement techniques, breathing exercises (diaphragmatic breathing, segmental breathing, local expansion, and pursed lip breathing),thorax mobilization exercises. (c) intervention time:the days 2 to 5 after surgery before discharging patients and one-month follow-up. (d) results: in this study pain is the primary outcome; quality of life, anxiety and hospital stay are the secondary outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010925913N1
Registration date: 2016-02-07, 1394/11/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Mohammad Zolfaghari
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3523 1421
Email address
mhmzolfaghari89@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Afshar cardiovascular research center of Yazd (affiliated with Shahid Sadoughi University of Medical Sciences and Health Services) will pay all costs of the survey.
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of classic chest massage therapy on pain following midsternotomy in the patients undergoing elective off-pump coronary artery bypass graft
Public title
the effect of classic chest massage therapy on pain in patients undergoing elective coronary artery bypass graft
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:all patients undergoing elective coronary artery bypass graft in the Afshar cardiovascular research center of Yazd (50 patients); exclusion criteria: patients with chest pain caused by trauma; patients with a previous history of cardiac surgery; patients with chronic pain syndrome; patients with prolonged bleeding during hospital stay (more than 200 cc per hour); patients who had psychiatric disorders; patients who didn't want to continue participating in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Afshar Cardiovascular Research Center affiliated with Shahid Sadoughi University of Medical Sciences
Street address
Afshar Cardiovascular Research Center, Jomhoori Blvd, Yazd, Iran
City
Yazd
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
746/ق/ت

Health conditions studied

1

Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts

Primary outcomes

1

Description
Pain
Timepoint
before intervention, the day 5 after intervention, one month after intervention
Method of measurement
using VAS questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
before intervention, the day 5 after intervention, one month after intervention
Method of measurement
using SF-36 questionnaire

2

Description
Anxiety
Timepoint
before intervention, the day 5 after intervention, one month after intervention
Method of measurement
using VAS questionnaire

3

Description
Hospital Stay
Timepoint
before discharge
Method of measurement
according to patient's medical record

Intervention groups

1

Description
intervention group: received classic chest physiotherapy control group: no intervention
Category
Treatment - Other

2

Description
Control group: in this study, the control group receive usual medications and cares Without any additional intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Cardiovacular Research Center of Yazd
Full name of responsible person
Dr. Seyed Jalil Mirhosseini
Street address
Afshar Cardiovascular Research Center, Jomhoori Blvd, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Afshar Cardiovascular Reaserch Center of Yazd
Full name of responsible person
Dr. Soltani- manager of Afshar Cardovascular Reaserch Center of Yazd
Street address
Afshar Cardiovascular Research Center, Jomhoori Blvd, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Afshar Cardiovascular Reaserch Center of Yazd
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
Shahid Sadoughi Univesity of Medical Sciences and Health Services
Full name of responsible person
Mohammad Zolfaghari
Position
Medical Student
Other areas of specialty/work
Street address
Golestan Enghelab dormitory, Shohadaye Gomnam Blvd, Safaie, Yazd, Iran
City
Yazd
Postal code
8915173143
Phone
+98 353821308690
Fax
Email
mhmzolfaghari89@ssu.ac.ir, mhmzolfaghari89@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Afshar Cardiovascular Hospital
Full name of responsible person
Dr. Seyed Jalil Mirhosseini
Position
MD, PhD
Other areas of specialty/work
Street address
Afshar Cardiovascular Hospital, Jomhoori Blvd, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3523 1421
Fax
Email
jalilmh1@yahoo.com, mhmzolfaghari89@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Zolfaghari
Position
Medical student
Other areas of specialty/work
Street address
Golestan Enghelab dormitory, Shohadaye Gomnam Blvd, Safaie, Yazd, Iran
City
Yazd
Postal code
8915173143
Phone
+98 353821308690
Fax
Email
mhmzolfaghari89@ssu.ac.ir, mhmzolfaghari89@gmail.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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