This randomized, controlled clinical trial with three groups aims to compare the effects of foot reflexology massage and stroke massage on depression of patients with MI admitted to heart ward of Vali-Asr Hospital of Birjand. The patients with inclusion criteria (first time MI; age between 40 and 70 years; time passed since MI more than 48 hours; non-history of psychological problems, depression and use of anti-depressants; not having skin or neurological disorders; not having counter-indications for massage such as active infection, breakage and wound; non-addiction) will first complete Beck Depression Inventory. They will enter the study according to the score they obtain. Participants will be 60 who will be assigned into 3 groups randomly, including foot reflexology massage, stroke massage, and control groups. Intervention will be performed through 5 weeks (3 days a week, 2 sessions per day in the morning and afternoon; 30 sessions in total) in the intervention groups by the researcher during hospitalization or continued at home by the patient’s main companion if approved by the researcher. The controls will simply get informed of not using anti-depressants. The patient will be excluded from the study in case s/he or his/her main companion does not have the tendency to continue; or in case a physical problem happens to them, inhibiting them from continuation. After the fifth session, the inventory will be completed again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060817756N2
Registration date:2016-06-14, 1395/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-09-28, 1395/07/07
Expected recruitment end date
2016-10-28, 1395/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of foot reflexology massage and stroke massage on depression of patients with Myocardial Infarction
Public title
Effects of foot reflexology massage and stroke massage on depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: first time MI; time passed since MI more than 48 hours; non-history of psychological problems, depression and use of anti-depressants; not having skin or neurological disorders; not having counter-indications for massage such as active infection, breakage and wound; non-addiction; at least 6 hours passed from use of narcotic drugs and tranquilizers.
Exclusion criteria: The patient or his/her main companion does not have the tendency to continue; a physical problem happens to them, inhibiting them from continuing the study
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
Ir.bums.1395.4
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
f32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
5 weeks from the start of treatment
Method of measurement
Beck Depression Score
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group (foot reflexology massage): Upon completing pre-test, which will be taken using Beck Depression Inventory, the group will go through 5 weeks of foot reflexology massage (3 days a week, 2 sessions per day in the morning and afternoon; 30 sessions in total) by the researcher during hospitalization or continued at home by patient’s main companion if approved by the researcher. At the end of the fifth week, the inventory will be completed again.
Category
Rehabilitation
2
Description
The second intervention group (stoke massage): Upon completing pre-test, which will be taken using Beck Depression Inventory, the group will go through 5 weeks of stroke massage (3 days a week, 2 sessions per day in the morning and afternoon; 30 sessions in total) by the researcher during hospitalization or continued at home by patient’s main companion if approved by the researcher. At the end of the fifth week, the inventory will be completed again.
Category
Rehabilitation
3
Description
Control group: The members will enter the study in similar lines with other groups; however, they will not receive any intervention associated with depression during the study. At the end of the fifth week, they will complete the inventory again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital, Cardiology Department
Full name of responsible person
Zeinab Saremi
Street address
Vali-Asr Hospital, Ghaffari St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Deputy of Reserach, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Birjand 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
Faculty of Nursing and Midwifery, Birjand University of Medical Sciences
Full name of responsible person
Zeinab Saremi
Position
Master Student of Medical-Surgical Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences; Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zeinab Saremi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zeinab Saremi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)