The aim of this three group clinical trial is to investigate the comparison of the effect of foot reflexology on state- trait anxiety patients. 132 patients will be recruited in the three study groups: metatarsus reflexology massage, ankle reflexology massage and control group. Massage is done in the third and fourth days in women and men ward surgery in 8-9 am. Spielberger standard questionnaire is given to patients pre and post intervention and we ask the patients that to fill them. Duration of massage is 10 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100310996N1
Registration date:2012-11-04, 1391/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-04, 1391/08/14
Registrant information
Name
Mahnaz Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1430 4113
Email address
mahnaz.ahmadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-10-02, 1391/07/11
Expected recruitment end date
2012-12-01, 1391/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effect of two reflexology massage methods of metatarsus and ankle on state-trait anxiety after coronary artery bypass graft
Public title
The effect of foot reflexology massage on patients anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age range between 26 to 65 years; having at least primary education; graft is removed from the patients left foot; health in the legs, espicially the palm and thumb of right foot and patients not taking the drug. Exclusion criteria: conditin of hemodynamic is unstable; transfer of patient to intensive care unit and cardiopulmonary resuscitation of the patient.
Age
From 26 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
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
Kermanshah University of Medical Sciences Ethics Committee
Street address
No.2 building, Kermanshah University of Medical Sciences, next to Sepah square, Shahid Beheshti boulevard
City
Kermanshah
Postal code
67144-73159
Approval date
2012-09-11, 1391/06/21
Ethics committee reference number
/420/7/پ
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F50-59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
Anxiety
Timepoint
Third and fourth days after Coronary artery bypass surgery
Method of measurement
Spielberger standard questionnaire
Secondary outcomes
1
Description
state-trait anxiety
Timepoint
on the third and fourth days after cabg surgery
Method of measurement
spielberger standard questionnaire
Intervention groups
1
Description
Matatarsus foot reflexology massage is done in the intervention group on third and fourth days after CABG. Duration of massage is ten minutes.
Category
Other
2
Description
In the control group, no intervention will be done.
Category
N/A
3
Description
Ankle foot reflexology massage is done in the plcebo on the third and fourth days after CABG. Duration of massage is ten minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Ali Akbar Visi Raygan
Street address
Emam alli hospital, next of sepah squqre, Shahid Beheshti boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
No.2 building, Kermanshah University of Medical Sciences, next to Sepah square, Shahid Beheshti boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
ali akbar visi raygan
Position
MSC
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to Ashayer square, Dolat Abad
City
kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
avisi@kums.ac.ir; visi_akbar @yahoo.com
Web page address
www.kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Visi Raygan
Position
MSC
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to Ashayer square, Dolat Abad
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1727 9394
Email
visi_akbar@ yahoo.com
Web page address
www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Visi Raygan
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to Ashayer square, Dolat Abad
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
avisi@ums.ac.ir
Web page address
www.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)