Comparative study of the effect of massage therapy and cryotherapy on pain and lung volume in patients undergoing coronary artery bypass graft surgery.
This study is a single-blind clinical trial with the control group in order to evaluate and compare the two techniques of Swedish massage and cryotherapy to reduce the pain and lung volume in patients undergoing coronary artery bypass graft surgery. 75 patients undergoing coronary artery bypass graft surgery were examined. The main criteria to start the study involving: the patient age is between 35 to 75 years; Thorax surgery is the first patient’s experience; Cardiac output is more than 40%. Exclusion (external) criteria including: the placement of Chest tube at the time of data collection and severe emotional stress during the evaluation. Patients were divided into three groups: massage therapy, cryotherapy and control. In order to determine the severity of pain, visual analogue scale (VAS) was used also to determine the lung volumes, Spirometry unit was used. The level of pain and the lung volumes were measured for two times, 10 to 15 minutes before and 10 to 15 minutes after intervention. Massage therapy and cryotherapy intervention were done once for 20 minutes in the first 48 hours after surgery. Control patients received routine care and similar environmental intervention groups were provided for them then they were encouraged to rest in bed. The level of pain and spirometry were measured in two times, 10 to 15 minutes before and 10 to 15 minutes after rest.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051022192N1
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Elham Ali Ahmadi
Name of organization / entity
Zahedan University of Medical Science, School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 3644
Email address
ealiahmadi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of massage therapy and cryotherapy on pain and lung volume in patients undergoing coronary artery bypass graft surgery.
Public title
The effect of massage therapy and cryotherapy on pain and lung volume in patients undergoing open heart surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Based on previous planning the patient underwent surgery. (Elective surgery); the patient age must be between 35 to 75 years; Personal medicines such as hypnotics, benzodiazepines, sedatives, drugs and alcohol must not be used ; The minimum pain score by visual scale of pain before intervention was 40; The history of diabetes was less than 5 years; Thorax surgery is the first patient's experience; The type of graft used for patient was saphenous vein or left mammary artery; the patient does not suffer from chronic respiratory disease; Cardiac output was more than 40% based on echocardiography performed before surgery. Exclusion criteria: Patients who had a lot of pain and did not want to be touched or to continue; The placement of Chest tube was at the time of data collection; Suffering from post-operative complications such as infection, bleeding, open wound (wound dehiscence) or uncontrolled dysrhythmia; severe emotional stress during the study; Patients who have received sedatives other than the routine sedatives or the use of analgesics was less than 4 hours before the intervention.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Single-blind study because of pain and lung volumes were measured by anyone other than researcher.
Research on Three Card cryotherapy, massage therapy and control written and the box has poured randomly selected.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.ZAUMS.REC.1394.101
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
151.6
ICD-10 code description
atherosclerotic cardiovascular disease
Primary outcomes
1
Description
Pain intensity
Timepoint
10 to 15 minutes before and 10 to 15 minutes after intervention
Method of measurement
In order to determine the severity of pain visual analog scale was used.
2
Description
Lung volumes
Timepoint
10 to 15 minutes before and 10 to 15 minutes after intervention
Method of measurement
Model spirometer Spiro lab III, Tuk - MIR009, ITALY
Secondary outcomes
empty
Intervention groups
1
Description
The Patients of the massage group: Swedish massage for 20 minutes, 48 hours after surgery with mild to moderate pressure, The Place of the massage depends on the willingness of the patient. Scentless and fragrance from a lubricant (glycerin) was used.
Category
Other
2
Description
The Patients of cryotherapy group: Frozen Gel packs of 10 x 14 cm with a weight of 175 g , it was put out of the fridge an hour before the intervention in a cloth cover and it was laid on the sternum dressing For 20 minutes intermittently every 5 to 10 minutes.
Category
Treatment - Other
3
Description
The patients in the control group: patients received routine care and similar environmental intervention groups were provided for them. The companions of the patient left the room for 20 minutes then the patient was encouraged to rest in bed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Hospital
Full name of responsible person
Changiz Azadi Ahmad Abadi
Street address
Ali Ebne Abitaleb Hospital, Khalije Fars Blvd
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Science
Full name of responsible person
Hooshang Rafighdost
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square,
City
Zahedan
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 of Zahedan University of Medical Science
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
Zahedan University of Medical Science, School of Nursing & Midwifery