The study aimed to compare the effects of pranayama Sukha and hand reflexology on the anxiety and hemodynamic status of patients undergoing coronary angiography.the clinical trial is a three group type random sampling block. Patients who referred for coronary angiography for the first time and aquired an anxiety score of >= 43 are included.and would be excluded in the case of not tolerating. the sample size was 35 case in each group and a total of 105 cases. in the control group only the routine pre angiographic measures would be done.
in the pranayama sukha beside the routine measures, the case would perform the same inhalation and exhalathion for 5 min under the supervision of researcher; in the reflexology intervention group for hand, the heart point relevent to the heart are touched in both hands by the the researcher in addition to routine measures. the anxiety level,hemodynamic status and the dysrhthmia of the case immediatly before/after and 5,30,60 min after the campletion of intervention.
in the present study the impact of interventions at the post interventional intervals would be examined and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308024655N6
Registration date:2016-01-24, 1394/11/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of pranayama Sukha and hand reflexology on anxiety and hemodynamic status of patients undergoing coronary angiography
Public title
Compare the effect of pranayama breathing and hand reflexology on anxiety in patients undergoing coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
willing to participate in the study; for the first time the case is to be hospitalized for coronary angiography; having the hemodynamic stability prior to angiography; no history of heart infarction and surgery; no current history of addiction to narcotics; no previous use of sedatives or anxiolytics,e.g propranolol, over 72 hours; no history of epilepsy and the known disorders of thyroid; having no local problems at the point of reflexology in hand; no positive history for pulmonary disorders; having an anxiety scare of >= 43.
Exclusion criteria:
unwillingness to participate in study; intolerance to intervention, unstable vital signs during the study and the occurance of any problems that the patient is no longer able to continue participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.KAUMS.REC.1394.84
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention - intervention after half an hour - an hour after the intervention.
Method of measurement
Trait Anxiety Inventory
2
Description
blood pressure
Timepoint
10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention.
Method of measurement
Millimeters of mercury
3
Description
Pulse
Timepoint
10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention.
Method of measurement
The number in minutes
4
Description
Breathing
Timepoint
10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention.
Method of measurement
The number in minutes
Secondary outcomes
1
Description
Heart disrhythm
Timepoint
Before intervention - within 30 minutes after the intervention.
Method of measurement
Using the List by cardiac monitoring
Intervention groups
1
Description
Hand reflexology intervention group, patients in the sitting position, the leg to the wrist, palm, fingers on the hands and the patient is 8 to 10 times by researcher massage. To perform this technique washed with warm water and massage therapist's hands with thumb and first left hand then right hand starts patient. The reflection of Cardiology includes (1) the solar plexus and diaphragm located in the center of the palm at the base of the tip of the middle finger,(2) thyroid and parathyroid glands are located on the side of rule of thumb,(3) lung in hand on the tip of the middle finger and ring finger, ring finger (4) heart in the palm of the hand below the lower lobe small, (5)- adrenal glands located above the tendon thumb about one-third the distance between the base of the index finger and wrist kidney (6)- located in the interior index finger is directly under the thumb tendon. Each of the reflection by the researcher thumb is pressed so that the patient felt the pressure but not pain. The massage is performed to the number specified in the image below. Reflection points 14 times in succession in a clockwise direction without being interrupted for a period of skin contact being massaged
Category
Other
2
Description
Pranayama breathing intervention Sukha: First, a general explanation of the method is given. Then the patient in the sitting position so that his hands resting on the thighs perfect legs, it is. The patient is asked to close their eyes to get a better internal focus. Svkha pranayama and relaxation through the nasal passages and on a regular basis with the use of lower, middle and upper lung sequentially performed for each inhalation and exhalation. Time to inhale and exhale in this type of breathing and respiratory rate of 6 per minute. Researchers using hypnosis spoken over the management of the patient's breathing, conscious use of all parts of the lungs provides patient. The patient is said to not think about anything except your breathing, breathe when doing strength and energy into your lungs and exhaled with action, tension, stress and disease out of the body. RR 6 times per minute with equal respiration by measuring the time taken by the stopwatch
Category
Other
3
Description
In addition to the routine care of patients in the control group of patients undergoing coronary angiography by simple massage will be 8 to 10 times
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for of Kashan Medical University
Full name of responsible person
Taghadsi Mohsen
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan Medical University
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan Medical University
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
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD - director of journal pheyz Department
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
Taghadosi_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD - director of journal pheyz Department
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
Taghadosi_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Mobini bidgoli Maryam
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
maryammb148@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)