After learning "foot Reflexology technique", one day before angiography test, the researcher goes to Cardiology and CCU wards of Hospital and selects his candidates according to inclusion and exclusion criteria. Then he divides the study groups in odd or even. Number of samples in each group are 50. Inclusion criteria contain: Male patients hospitalized in CCU ; Being conscious; Willing to participate. Exclusion criteria contain: No willing to continue the study. Anxiety rate is determined by Spielberger questionnaire. Then anxiety rate and vital signs are determined and compared between 2 groups before and after the study. The technique is done as described below: the researcher washes his hands with warm water and then uses a softening oil (without any therapeutic effect) that only facilitate the massage (like sunflower oil). Massage starts from left foot in 3 points contained sensitive solar network, hypophysis and heart. These points are pressed constantly for 2 minutes and then they are massaged in a circle manner. Thirty minutes after doing technique, vital signs will be checked and anxiety Spielberger questionnaire will be completed again. Reflexology can be done only once before angiography. Vital signs determine by a mercury Sphygmomanometer (alkp2-Japan) and a digital watch Casio Japanese N1df model. blood pressure will be measured by a mercury Sphygmomanometer. Heart and respiratory rate will be measured by a digital clock.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082710677N1
Registration date:2012-12-14, 1391/09/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-14, 1391/09/24
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Kashan University of Medical Sciences, Kashan
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0366
Email address
mehdi.molavi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kashan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot reflexology on anxiety rate and vital signs before coronary angiography in males hospitalized in coronary care unit
Public title
Effect of foot reflexology on anxiety rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male patients hospitalized in CCU ; Being conscious; Willing to participate; Not using anticoagulation medications; No diabetes; Do not have the risk of deep vein thrombosis; No drug addiction; Without any history of psychologic problems or strong anxiety personality; Not being an emergency angiography case; Not taking anti-anxiety medication in the past 48 hours. Exclusion criteria: Not having the ability or willing to continue the study.
Age
From 18 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Simple random sampling is based on a coin toss. The samples are placed in two groups, odd and even.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
88141/87159
Approval date
2012-06-08, 1391/03/19
Ethics committee reference number
1607/1/5/29/ب
Health conditions studied
1
Description of health condition studied
Angina pectoris
ICD-10 code
120.0
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
blood pressure
Timepoint
Before and 30 minutes after reflexology
Method of measurement
Sphygmomanometer
2
Description
Heart rate
Timepoint
Before and 30 minutes after reflexology
Method of measurement
Digital watch
3
Description
anxiety
Timepoint
before and 30 minutes after reflexology
Method of measurement
Spielberger questionnaire
4
Description
Respiratory rate
Timepoint
Before and 30 minutes after reflexology
Method of measurement
digital watch
Secondary outcomes
1
Description
marital
Timepoint
before intervention
Method of measurement
married- single
2
Description
type of angiography
Timepoint
before intervention
Method of measurement
Therapeutic-Diagnostic
3
Description
age
Timepoint
before intervention
Method of measurement
years
Intervention groups
1
Description
group 1: Reflexology will be done one hour before angiography and vital sings and anxiety rate will be checked 30 minutes before and after reflexology.Then Spielberger questionnaire will be filled.
Category
Treatment - Other
2
Description
group 2 : Foot massage will be done 1 hour before angiography and vital sings and anxiety rate will be checked 30 minutes before and after massage. Then Spielberger questionnaire will be filled.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital of Kashan
Full name of responsible person
Mehdi Molavi Vardanjani
Street address
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Beheshti Hospital, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
City
Kashan
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 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
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Science
Other areas of specialty/work
Street address
Kashan, 5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
87159/88141
Phone
+98 36 1555 0366
Fax
---------------------
Email
mehdi.molavi@kaums.ac.ir
Web page address
ندارد
Person responsible for scientific inquiries
Contact
Name of organization / entity
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
Full name of responsible person
Masoudi Negin
Position
PHD
Other areas of specialty/work
Street address
Kashan, 5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
87159/88141
Phone
+98 36 1555 0366
Fax
ندارد
Email
alavi.negin@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Science
Other areas of specialty/work
Street address
Kashan, 5th km Ghotb Ravandi, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
87159/88141
Phone
+98 36 1555 0366
Fax
----------------------
Email
mehdi.molavi@kaums.ac.ir
Web page address
www.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)