Protocol summary

Summary
Important goals:  - The effect of reflexology foot on anxiety in patients undergoing coronary angiography. They are accepting patients before angiography in patients who are next on the list of the day's action and will meet are eligible to enter the study, and after their introduction to the research units of the interview, conscious corporate research and demographic questionnaire will be completed Spielberger Anxiety Inventory. Then, using simple random sampling (three colored beads) intervention and control groups 1 and 2 will determine.  At 6 am to 8 am on angiography questionnaire mode - as characteristics by helping researchers in all three groups will be filled Intervention (metatarsus) by the researcher in the intervention group and one hour after the metatarsus, the state Spielberger questionnaire will be filled by research assistant and also, at the time called the patient to the angiography room for the second time in a state of anxiety will be measured by the research assistant. Inclusion criteria: Age range 40-80 years Expressed a desire to participate in the study Full consciousness Health benefits, especially in the foot member Obtaining a score of more than 40 of the scale of the Spielberger questionnaire Man Exclusion criteria: Lack of consent to continue participating in the study Cancel during the angiographic study Having a history of reflexology in the last three months The main intervention: Reflexology foot massage, will be associated with the reflection of the heart. The main outcome variables: measure the level of anxiety.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070723116N1
Registration date: 2015-12-20, 1394/09/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Keivan Hosseingholipour Miyandoab
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44333706942
Email address
k.gholipour@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Foot Reflexology on Angiography Anexiety
Public title
Effect of Foot Reflexology on Angiography Anexiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: aged 40-80 years expressed a desire to participate in study ؛ Having a health alert, especially in the foot member Arthur ؛ No Line on foot؛ Lack of bleeding disorders and the lack of anti-anxiety medication 48 hours before the intervention؛ The lack of any mental disorder 8. jobs do not belong to the absence of any drug therapy؛ history of diabetes for over 10 years ؛ Not having a heart pacemaker, bradycardia and hypotension ؛ The lack of non-participation in other clinical trials simultaneously Exclusion criteria: The lack of consent to continue participating in study ؛ cancel during the angiographic study؛ Any problem happened during Mtaalh) chest pain, shortness of breath ؛ having reflexology in the last three months
Age
From 40 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using three colored beads

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

2

Registry name
-
Secondary trial Id
--
Registration date
empty

3

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
Azadi Street, zanjan
City
Zanjan
Postal code
Approval date
2015-08-11, 1394/05/20
Ethics committee reference number
ZUMS.REC.1394.145

Health conditions studied

1

Description of health condition studied
coronary disease
ICD-10 code
I51.6
ICD-10 code description
I25.0

Primary outcomes

1

Description
Anxiety Level
Timepoint
Before and After Than foot Reflexology and immediately before angiography
Method of measurement
Spilberger Questionnare

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Case 1: The metatarsus Reflexology associated to heart
Category
Other

2

Description
Control group 1: The metatarsus associated with the uterus
Category
Other

3

Description
Control 2: Without any massage
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Moosavi Educationoremedial Center, Zanjan
Full name of responsible person
Keiwan Hosseingholipour Miyandoab
Street address
Zanjan Nursing and Midwifery Faculity
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Zanjan University of Medical Sciences
Full name of responsible person
Dr. Sograt , Fagihzadeh
Street address
Azadi Sreet, Zanjan, Iran
City
Zanjan
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 Zanjan 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
Zanjan University of Medical Science
Full name of responsible person
Dr.korosh Amini
Position
Doctrate
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3377 2514
Fax
Email
korosh@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
zanjan University of Medical Science
Full name of responsible person
Dr.korosh amini
Position
Nursing Doctrate
Other areas of specialty/work
Street address
Nursing and Midwifery Faculity, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3377 2514
Fax
Email
korosh@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan Nursing and Midwifery Faculity
Full name of responsible person
Keivan Hosseingholipour Miyandoab
Position
Critical Care Nursing Student
Other areas of specialty/work
Street address
City
Zanjan
Postal code
Phone
+98 24 3377 2514
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...