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The effect of foot reflexology on fatigue, pain and physiological parameters in patients after coronary angiography

Protocol summary

Summary
This study is a clinical trial to determine The Effect of foot reflexology on Fatique and pain and physiological parameters of Hospitalized patients after coronary angiography in Baqiyatallah educational-therapeutic and research center ., 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, Not arrhythmia, , Absence of history of coronary angiography and Using reflexology. Study exclusion criteria included:lack of patient consent to continue participating in the study, and CPR for patient bleeding. The sample of study included 70 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 (35 people), reflexology and a control group (usual care) . Fatique, Pain and physiologic parameters(systolic and diastolic blood pressure , pulse rate, respiratory rate) Questionnaire is measured by collaborator 2 hours after angiography. In reflexology group, massage is done by researcher (and man collaborator for male patients) for 10 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. Fatique and pain and physiologic parameters Questionnaire is recorded and assessed by collaborator ,2 hours after angiography and 2 and 4 hours after the procedure again. In the control group intervention will not occur, except routine care and vital signs measurement . Fatique and pain 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: IRCT2015072223286N1
Registration date: 2016-04-08, 1395/01/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Ali Shokatiasl
Name of organization / entity
Faculty of Nursing and Midwifery، Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4432 3872
Email address
a-shokati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Science and Technology of Tehran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on fatigue, pain and physiological parameters in patients after coronary angiography
Public title
The effect of foot reflexology on fatigue, pain and physiological parameters in patients after coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in research ; non-emergency angiography ; The age range of eighteen to seventy-five years ; No disturbance of consciousness ; Lack of vascular injuries of the lower limbs and sensory-motor disorders of the feet (especially Diabetic Foot) ; The absence of abnormalities such as corns, burns, amputations and skin disorders in the legs ; lack of inter-vertebral disc herniation, low back pain and back pain Exclusion criteria: Failure to consent to continued participation ; Death participants ; hemodynamic instability (dysrhythmia, respiratory disorders, and severe changes in blood pressure requiring emergency interventions ; bleeding after angiography
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: 35
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
Faculty of Nursing and Midwifery , Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences ، Nosrat St، Tohid Sq، Tehran, Iran
City
Tehran
Postal code
1419733171
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.TUMS.REC.1394.1407

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders

2

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

3

Description of health condition studied
Angiography
ICD-10 code
R93.1
ICD-10 code description
Abnormal findings on diagnostic imaging of heart and coronary circulation

Primary outcomes

1

Description
Fatigue
Timepoint
Baseline and 2, 4 and 6 hours after intervention
Method of measurement
Visual Analoge Scale for Fatigue

2

Description
Pain
Timepoint
Baseline and 2, 4 and 6 hours after intervention
Method of measurement
Visual Analoge Scale for Pain

3

Description
Blood pressure
Timepoint
Baseline and 2, 4 and 6 hours after intervention
Method of measurement
Tytan Blood Pressure Devices

4

Description
Pulse
Timepoint
Baseline and 2, 4 and 6 hours after intervention
Method of measurement
According to minutes using the standard clock

5

Description
Breathing
Timepoint
Baseline and 2, 4 and 6 hours after intervention
Method of measurement
According to minutes using the standard clock

Secondary outcomes

empty

Intervention groups

1

Description
In reflexology group, massage is done by researcher and man collaborator( for male patients ) )for 10 minutes(5 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. With fatigue and pain VAS and physiologic parameters Questionnaire is recorded and assessed by collaborator , 2 hours after angiography, 2 and 4 hours after the procedure again.
Category
Other

2

Description
In the control group intervention will not occur, except routine care and vital signs measurement.fatique ,pain and physiologic parameters Questionnaire recorded by collaborator and with presence of researcher at intervals corresponding reflexology group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Science
Full name of responsible person
Street address
MollaSadra St، Sheikh Bahai st، Tehran، Iran، Baqiyatallah University of Medical Science
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi، Reasearch Vice chancellor، Tehran University of Medical Sciences
Street address
Nosrat St، Tohid Sq، Tehran, Iran، Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
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 Tehran 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
Faculty of Nursing and Midwifery، Tehran University of Medical Sciences
Full name of responsible person
Ali Shokatiasl
Position
MS Student in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery، Tehran University of Medical Sciences، Nosrat St، Tohid Sq، Tehran, Iran
City
Tehran
Postal code
1474948499
Phone
+98 21 4432 3872
Fax
Email
a-shokati@razi.tums.ac.ir; shokati16@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery، Tehran University of Medical Sciences
Full name of responsible person
Elham Navab
Position
Faculty، Assistant
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St، Tohid Sq، Tehran، Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6105 4412
Fax
Email
e_navab100@hotmail.com; enavab@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences,
Full name of responsible person
Ali Shokatiasl
Position
MS Student in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St، Tohid Sq،1419733171, Tehran، Iran،
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6694 1668
Email
a-shokati@razi.tums.ac.ir; ashokati16@yahoo.com
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
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