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The Effect of foot reflexology on anxiety and physiological parameters of patients undergoing coronary angiography

Protocol summary

Summary
This study is a clinical trial to determine The Effect of foot reflexology on anxiety and physiological parameters of Hospitalized patients undergoing coronary angiography in Dr.Heshmat educational-therapeutic and research center, rasht ., Inclusion criteria included: Age of 75 -18 years, Heart rate above the 60 beats per minute and systolic blood pressure above the 90 mm Hg, Temperature of 36.5 ° -37.5 ° C, Not arrhythmia, , Absence of history of coronary angiography and Using reflexology, relaxation and Psychotherapy episodes. Study exclusion criteria included: Patient's dissatisfaction to participate in research,Cardiopulmonary resuscitation . Cancellation angiography during the study.Creates any problem during the study. The sample of study included 162 patients and satisfacted to participate in the study. The sample are selected with random sampling and using the method of putting the Random blocks in two groups (81 people), reflexology and a control group (usual care) . Anxiety and physiologic parameters(systolic and diastolic blood pressure , pulse rate, respiratory rate, temperature) Questionnaire is measured by collaborator 10 minutes before the start of the intervention. In reflexology group, massage is done by researcher (and man collaborator for male patients) for 20 minutes. The sequence are used of relaxation and specific areas of the heart. Stages of massage include: - Rhythmic ankle rotation, Wringing the foot, massage of solar plexus, pituitary, and heart. Anxiety and physiologic parameters Questionnaire is recorded and assessed by collaborator ,Immediately and half an hour after the procedure again. In the control group intervention will not occur, except routine care and vital signs measurement . Anxiety and physiologic parameters Questionnaire recorded by collaborator and with presence of researcher at intervals corresponding test groups .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102711538N2
Registration date: 2015-01-08, 1393/10/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Farideh Hasavari
Name of organization / entity
Guilan University of Medical Sciences(Nursing & Midvifery Faculty)
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
fhasavari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of foot reflexology on anxiety and physiological parameters of patients undergoing coronary angiography
Public title
The Effect of foot reflexology on anxiety and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 -75 years; Full awareness and ability to communicate; Without history of coronary angiography and Using reflexology; Absence of relaxation and Psychotherapy episodes; Absence of effective psychiatric medication according of the patient statements and material in file; Heart rate above the 60 beats per minute ; systolic blood pressure above the 90 mm Hg; Temperature of 36.5 ° -37.5 ° C; Not arrhythmia ; Absence of addiction to drugs and alcohol according to file; Absence employment in medical treatment; Absence of fractures; wounds and skin problems in the areas of massage. exclusion criteria: Patient's dissatisfaction to participate in research;Cardiopulmonary resuscitation ; Cancellation angiography during the study;Creates Chest pain and dyspnoea
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 162
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
guilan university of medical science
Street address
Namjoo Street, Guilan University of Medical Science
City
rasht
Postal code
41938-33697
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
2930400409

Health conditions studied

1

Description of health condition studied
anxiety ,physiological parameters
ICD-10 code
f50-f59,R0
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems,Behavioural syndromes associated with physiological disturbances and physical factors

Primary outcomes

1

Description
anxiety and- physiological parameters
Timepoint
10 minutes before of the intervention-Immediately -half an hour after the procedure
Method of measurement
Hospital Anxiety Questionnaire-Measure blood pressure in millimeters of o mercury by using mercury manometers-Temperature in degrees Celsius by using mercury thermometer-Pulse and respiratory rate counting is based on the number of minutes in one minute using an analog clock complete

Secondary outcomes

empty

Intervention groups

1

Description
In reflexology group, massage is done by researcher and man collaborator( for male patients ) )for 20 minutes(10 minutes per foot). The sequence are used of relaxation and specific areas of the heart. Stages of relaxation include: Rhythmic ankle rotation( ankle rotation 4 time in the right and 4 times to the left to form the circle)and Wringing the foot( researcher thumbs are placed on the patient's abdominal area,then wringing the toe to the ankle,this work will be done 3 times) . After relaxation are used to stimulate the three areas of reflecting the solar plexus,heart,pituitary.the downward pressure are applied with the thumb in the heart,pituitary,solar plexus. then circular massage are applied the same points. Anxiety and physiologic parameters Questionnaire is recorded and assessed by collaborator ,Immediately and half an hour after the procedure again.
Category
Treatment - Other

2

Description
In the control group intervention will not occur, except routine care and vital signs measurement . Anxiety and physiologic parameters Questionnaire recorded by collaborator and with presence of researcher at intervals corresponding reflexology group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat training center
Full name of responsible person
farideh hasavari
Street address
Toshiba-intersection Heshmt- Heshmat Hospital
City
rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
guilan university of medical sciences
Full name of responsible person
Doctor Abtin Heidarzadeh
Street address
namjoo street-guilan university of medical science
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
guilan 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
guilan university of medical science
Full name of responsible person
maria khorsand fard
Position
ms of Medical Surgical student(msc)
Other areas of specialty/work
Street address
nursing of midwifery faculity,daneshjoo street,shahid beheshti ring way,rasht
City
rasht
Postal code
41941-68648
Phone
+98 13 3372 9257
Fax
+98 13 3355 0097
Email
merinderella@yahoo.com
Web page address
http://gums.ac.ir/nmr/defult-1406.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
guilan university of medical science
Full name of responsible person
farideh hasavari
Position
ms of Medical Surgical
Other areas of specialty/work
Street address
nursing of midwifery faculity,daneshjoo street,shahid beheshti ring way,rasht
City
rasht
Postal code
41469-68648
Phone
+98 13 3355 5056
Fax
+98 33550097
Email
fHasavari@gums.ac.ir f.hasavari@gmail.com
Web page address
http://www.gums.ac.ir/nmr/defult-1406.aspx

Person responsible for updating data

Contact
Name of organization / entity
guilan university of medical sceince
Full name of responsible person
farideh hasavari
Position
MS of Medical Surgical
Other areas of specialty/work
Street address
nursing of midwifery faculity,daneshjoo street,shahid beheshti ring way,rasht
City
rasht
Postal code
41469-68648
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
fHasavari@gums.ac.ir f.hasavari@gmail.com
Web page address
http://www.gums.ac.ir/nmr/defult-1406.aspx

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
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