The aim of this study was to compare the effects of posted shortly feet reflexology massage and hands reflexology massage on anxiety patients undergoing coronary angiography. In this randomized clinical trial, 135 candidates of angiography were randomly allocated to three groups (first week for foot reflexology, second week for hand reflexology massage, third week for control group and again this random allocation is repeated) into experimental and control groups (35 patients in each group). The study will be conducted on female patients candidates for angiography in patients admitted to Kosar hospital in Semnan. Sampling begins after explaining the objectives of the study and obtaining informed consent from patients in different groups. In the foot and hand reflexology massage groups, patients were placed in a comfortable position and either feet or hands are messaged for ten minutes. Spielberger standard questionnaire and hemodynamic parameters will be gathered before and after intervention, and one minute after angiography. The control group will not receive any type of intervention and only anxiety and hemodynamic parameters will be measured after twenty minutes interval. The researchers and data monitoring committee will not become aware of what sort of intervention the patients have been received.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412087529N6
Registration date:2015-01-16, 1393/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-16, 1393/10/26
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2014-10-14, 1393/07/22
Expected recruitment end date
2015-01-10, 1393/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between of foot and hand reflexology on anxiety in patients with angiography candidates
Public title
Effect of massage on the level of anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
nclusion criteria: the desire to participate in the study; having no previous history of angiography; having no order of emergency angiography; having 20 number anxiety; age over 18 years old;; health in the legs and hands; patients not taking the narcotic drug alcohol, ; having no previous history of mental disorder; not using anticoagulation medications; No diabetes; Do not have the risk of deep vein thrombosis. Exclusion criteria: injury or infection at the site of reflex zone therapy; anxiolytic or hypnotic drugs in the 8 hours before reflex zone therapy; condition of hemodynamic is unstable; transfer of patient to intensive care unit and cardiopulmonary resuscitation of the patient.
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients are randomly allocated in to the three study groups: foot reflexology massage, hand reflexology massage and control group (35 patients in each group). Random allocated to intervention and control groups, assign patients were given this manner: (first week for foot reflexology, second week for hand reflexology massage, third week for control group and again this random allocation is repeated )The researchers and data monitoring committee will not become aware of what sort of intervention the patients receive.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Postal code
Approval date
2014-09-09, 1393/06/18
Ethics committee reference number
4/629
Health conditions studied
1
Description of health condition studied
Anxiety in patients with angiographic candidates
ICD-10 code
F40-48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
satisfaction
Timepoint
30 minutes after angiography
Method of measurement
satisfaction Visual Analog Scale
2
Description
Anxiety
Timepoint
Before intervention , one minute after intervention, and one minute after angiography
Method of measurement
Spielberger questionnaire
3
Description
Blood pressure
Timepoint
Before intervention , one minute after intervention, and one minute after angiography
Method of measurement
phygmomanometer
4
Description
Respiratory rate
Timepoint
Before intervention , one minute after intervention, and one minute after angiography
Method of measurement
Checklist
5
Description
Pulse rate
Timepoint
Before intervention , one minute after intervention, and one minute after angiography
Method of measurement
Checklist
6
Description
Oxygen saturation
Timepoint
Before intervention , one minute after intervention, and one minute after angiography
Method of measurement
pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
In foot reflexology massage group is done 20 minutes.(10 minutes for per foot).
massage techniques on reflex points of the pituitary, spinal cord and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb and leads to heel. The level of anxiety (measured by using spielburger questionnaire) and hemodynamic parameters (recorded in a checklist) are used before intervention , one minute after intervention, and one minute after angiography
Category
Other
2
Description
In hand reflexology massage group is done 20 minutes.(10 minutes for per hand).In the hand Reflexology group for the points massage, including the pituitary gland and solar plexus is performed. The level of anxiety (measured by using spielburger questionnaire) and hemodynamic parameters (recorded in a checklist) are used before and after intervention, while and after angiography
Category
Treatment - Other
3
Description
control group without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital in Semnan university of medical sciences
Full name of responsible person
Dr.Kamran Godus
Street address
Semnan university of medical sciences;Golestan street;Semnan;Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Fatemeh Heidari
Position
MSC
Other areas of specialty/work
Street address
Shahed University-Tehran, Iran
City
Tehran
Postal code
021
Phone
+98 21 51210
Fax
Email
fatemeh_heidari19@yahoo.com ,
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Postal code
Phone
+98 21 51210
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Postal code
1591715314
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)