Comparing the effects of therapeutic massage done by nurses and patients companion on reducing anxiety, vital signs and the blood cortisol level in males hospitalized in coronary care unit .
This study aimed to compare the effects of massage therapy (done by the nurse and by the patient's companion) on the anxiety, vital signs and the level of the serum cortisol of the male patients hospitalized in the CCU.
a randomized controlled clinical trial study will be conducted. a convenience sample of the patients will be randomly allocated to within the 3 groups randomly by using a dice. The dice numbers of 1 and 2 will be allocated within the first group, the dice numbers of 3 and 4 in the second group and the dice numbers 5 and 6 in the control group.
The first and second group will receive a session of total body massage therapy for bout 60 minutes. Massage therapy for the first group will be done by the nurse and for the second group by the patients' companion. The patients' vital signs, anxiety and serum cortisol levels will be checked immediately before and after the massage therapy session. Data analysis will be done by SPSS software. Parametric and non parametric statistical testes will be used to analyses the data.
General information
Acronym
Massage therapy
IRCT registration information
IRCT registration number:IRCT201112048296N1
Registration date:2012-02-11, 1390/11/22
Registration timing:na
Last update:
Update count:0
Registration date
2012-02-11, 1390/11/22
Registrant information
Name
Rahman Rajabi Beheshtabad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1444 8108
Email address
rajabi_ra@kaums.ac.ir
Recruitment status
Not enough for processing
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-03-19, 1391/12/29
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of therapeutic massage done by nurses and patients companion on reducing anxiety, vital signs and the blood cortisol level in males hospitalized in coronary care unit .
Public title
Comparing the effects of therapeutic massage done by nurses and patients companion on reducing anxiety, vital signs and the blood cortisol level in males hospitalized in coronary care unit .
Purpose
Supportive
Inclusion/Exclusion criteria
A) Inclusion criteria:
1. Male patients hospitalized in CCU
2. Being literate.
3. Being conscious
4. Stay in ward more than 3 days
5. Willing to participate
B) Exclusion criteria:
1- Discharge from the ward
2- Loss of consciousness
3 -Having cardiac arrest during the past 72 hours
4- Receiving warfarin
5- Having known mental disorder
6- having cardiac pacemaker
7- Bradycardia (pulse rate less than 60)
8- Severe dyspnea
9- Having burn more than 25% of BSA
10- Having known infectious disinvest or hepatitis and jaundice
11- Fever
12- Having amputed limb
13- Having known adrenal gland disorder
14- Having bone fractures in the past 2 months
15- Having known skin problem
16- Deep vein thrombosis
17- Having dialysis fistula.
Age
To 75 years old
Gender
Male
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics committee of Kashan University of Medical Sciences
Street address
Kilometer 5, Ghotb ravandi bilvard
City
Kashan
Postal code
88141/87159
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
3614/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Angina pectoris
ICD-10 code
120
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger questionnaire
2
Description
Serum cortisol
Timepoint
Before and after intervention
Method of measurement
Blood tests
3
Description
Vital signs
Timepoint
Before and after the intervention
Method of measurement
Blood pressure (sphygmomanometre), temprature (medical termometer), pulse and respiration (by the researcher, in 1 min.)
Secondary outcomes
empty
Intervention groups
1
Description
The first group (massage by the nurse): The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the nurse for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again.
Category
Behavior
2
Description
group II (massage by the patient's companion):
The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the patient's companion for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again.
Category
Behavior
3
Description
Group III (control group):
This group does not receive massage therapy, but will receive the routine care.
The patient's vial signs will be assessed on 30 minutes after being in bed. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. assessing the patient's vital signs, blood sampling and Spielberger questionnaire will be repeated after 75 minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan University of Medical Sciences
Full name of responsible person
Rahman Rajabi
Street address
Kashan University of Medical Sciences
City
Kashan
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Street address
Nursing Faculty, Kashan university of Medical sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam ali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Rahman Rajabi
Position
Graduate student
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87155/111
Phone
+98 36 1444 8108
Fax
+98 36 1557 5057
Email
rajabi_ra@kaums.ac.ir; rajabi.rahman@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib,
Position
Graduate student of nursing intensive care
Other areas of specialty/work
Street address
Kashan - 5 km ghotab Ravandi Blvd
City
Kashan
Postal code
81755/111
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
adib1344@yahoo.com;
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Rahman Rajabi
Position
Graduate student of nursing intensive care
Other areas of specialty/work
Street address
Kashan - 5 km ghotab Ravandi Blvd
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
rajabi_ra@kaums.ac.ir rajabi.rahman@yahoo.com
Web page address
www.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)