Objectives: The aim of this study is comparing the effects of massage therapy done by the nurse and by the patient's companion, on the pain intensity and sleep quality in post CABG patients.
Design: Randomized controlled clinical trial study
Setting and conduct: By convenience sampling,105 patients the patients who will be randomly allocated in 3 groups.
Eligibility criteria: Underwent CABG surgery; age between 18 and 70; hospitalization at least 3 days in cardiac surgery ward. exclusion criteria: Decrease level of consciousness; hemodynamic instability; unwillingness to continuing participation.
Intervention: Before the intervention, pain intensity in incision site and sleep quality will be assessed. Massage will be done by the nurse in the first group and by patient’s companion in the second group. Third group won’t receive any intervention except routing care.
Main outcome: Pain intensity will be assessed immediately, 30, 60, and 120 minutes after intervention. One day after second intervention, sleep quality will be assessed. Data analysis will be done by SPSS software by ANOVA and Scheffe assumptions test (LSD).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208218505N3
Registration date:2013-12-24, 1392/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-24, 1392/10/03
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Scinces
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of therapeutic massage by nurses and patients' companion on pain severity and sleep quality in post CABG patients
Public title
Comparing the effects of therapeutic massage by nurses and patients' companion on pain severity and sleep quality in post CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
A) Inclusion criteria: 1- Orientation to time, place & person; 2 - Minimum age 18 and maximum 70; 3- Post CABG patients; 4- Patients hospitalized in post heart surgery ICU and stay at least 3 days; 5- Willing to participate.
B) Exclusion criteria:1- Unwillingness to continuing participation; 2- Decrease level of consciousness; 3- Unstable hemodynamic status; 4- Patients who have coagulation problems; 5- Pump time more than four hours; 6- Patients who have chronic and malignant pain; 7- prescription of sedative drugs (over 0 .5 mg Alprazolam per day); 8- History of drug and alcohol abuse over the last two months; 9- History of diabetes over the last fifteen years; 10- History of neurological, cerebrovascular, cardiovascular, psychiatric and respiratory disorders.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz University of Medical Sciences Ethics Committee
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province,
City
Shiraz
Postal code
1978-71345
Approval date
2012-10-03, 1391/07/12
Ethics committee reference number
ct-91-6260
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
pain
Timepoint
before and immediately,30,60 minutes and 2 hours after the massage therapy
Method of measurement
visual analog scale
2
Description
sleep quality
Timepoint
before and one day after the last intervention
Method of measurement
SMHSQ
Secondary outcomes
empty
Intervention groups
1
Description
The first group (massage by the nurse): massage therapy will be done for 30 minutes by a nurse in the third and fourth post-op days. Pain severity will be assessed before, immediately, 30, 60, and 120 minutes after first massage therapy session. Sleep quality will be assessed before and one day after the last intervention.
Category
Behavior
2
Description
Group II (massage by the patient's companion): massage therapy will be done for 30 minutes by a patient's companion in the third and fourth post-op days. Pain severity will be assessed before, immediately,30, 60, and 120 minutes after first massage therapy session. Sleep quality will be assessed before and one day after the last intervention.
Category
Behavior
3
Description
Group III (control group): This group does not receive massage therapy, but in the third and fourth post-op days a nurse and a patient's companion remain with patient for 30 minutes. Pain severity will be assessed before, immediately, 30, 60, and 120 minutes after first session. Sleep quality will be assessed before and one day after last session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Sayed Saeed Najafi
Street address
Fateme (P.B.U.H.) school of nursing & midwifery, Namazi square, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Sayed Saeed Najafi
Street address
Karim- Khan Zand Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Scinces
Full name of responsible person
Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz. Shiraz Fars Iran, Islamic Republic Of
City
Shiraz
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, Shiraz University of Medical Scinces
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
Shiraz University of Medical scinces
Full name of responsible person
Rast Fazlollah
Position
Master of critical care nursing
Other areas of specialty/work
Street address
Fateme (P.B.U.H.) school of nursing & midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71164742546
Fax
+98 71 1647 4252
Email
fazlrast@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Sayed Saeed Najafi
Position
MS in nursing - Faculty member
Other areas of specialty/work
Street address
Fateme (P.B.U.H.) school of nursing & midwifery, Namazi square
City
Shiraz
Postal code
71936-13119
Phone
+98 71164742546
Fax
+98 71 1647 4252
Email
s_najafi44@yahoo.com
Web page address
http://nurs-midwif.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Fateme (P.B.U.H.) school of Nursing & Midwifery
Full name of responsible person
Rast Fazlollah
Position
Master ofssience on critical care nursing
Other areas of specialty/work
Street address
Fateme (P.B.U.H.) school of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
0711 -10987116474254-6
Fax
+98 71 1647 4252
Email
Fazlrast@yahoo.com
Web page address
http://nurs-midwif.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)