Assessment the effect of pressure on Yintang and shenmen points on anxiety and hemodynamic variable and dysrythmia of Patients Undergoing heart catheterization
This study aimed to determine the effect of acupressure on anxiety, hemodynamic and dysrhythmia in patients undergoing heart catheterization. This double-blind clinical trial was performed on 60 patients Undergoing heart catheterization. Inclusion criteria were age less than 65 years and being hemodynamically stable. Subjects that had taken sedative drugs and a history of heart surgery and catheterization and stroke, thyroid gland disorders, were excluded. Anxiety by Spielberger Scale and dysrhythmia was assessed with the check list. Patients were randomly assigned into two groups: real acupressure (n = 30) Non-real acupressure (control group) (n = 30). Massage balls with 1 Cm circle diameter on the points of Shenmen on the ear and Yintang, at the top of the nose on the center line between the ends of the eyebrows. Non-acupoints, which were 1 to 3 CUN (Chinese unit of length) away from true acupoints were used in control group. Anxiety, hemodynamic variables and dysrhythmia were measured before, 1 minute and 30 minutes after the intervention in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204304655N1
Registration date:2016-02-11, 1394/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-11, 1394/11/22
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
2013-07-10, 1392/04/19
Expected recruitment end date
2013-11-10, 1392/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of pressure on Yintang and shenmen points on anxiety and hemodynamic variable and dysrythmia of Patients Undergoing heart catheterization
Public title
The effect of acupressure on anxiety in patients undergoing catheterization
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 65 years; Being healthy place acupressure; having full consciousness and an acceptable ability of listening and speaking to persian; Lack of mental or physical disability; no history of heart surgery, catheterization and stroke; referred to catheterization for the first time.Exclusion criteria: Using of Narcotic drugs the day before the intervention; Taking Sedative drugs or anxiety drugs, such as propranolol tablet in more than a week ago; a history of epilepsy and known disorders of the thyroid gland; non-cooperation to continue research.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Approval date
2013-07-15, 1392/04/24
Ethics committee reference number
1680/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
ICD-10 : Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, 1 minute after the intervention, 30 minutes after the intervention
Method of measurement
Spillberger questionnaire
2
Description
pulse
Timepoint
Before the intervention, 1 minute after the intervention, 30 minutes after the intervention
Method of measurement
In millimeters of mercury
3
Description
Blood pressure
Timepoint
Before the intervention, 1 minute after the intervention, 30 minutes after the intervention
Method of measurement
In millimeters of mercury, by Using a mercury sphygmomanometer
Secondary outcomes
1
Description
Anxiety level
Timepoint
Before, 1 minute after the intervention, 30 minutes after the intervention
Method of measurement
By using the check List through cardiac monitoring
Intervention groups
1
Description
Intervention group (Group acupressure massage):
In this group, Effective points in anxiety, Shenmen point was in the non-dominant ear(eyebrows Yintang point in the middle of the nasal root). At this points, the massage ball with a diameter of one centimeter with an average of 25-20 cycles per minute for 10 minutes was performed. Amount of pressure was at 4-3 kg, So that they feel the pressure, but do not feel pain in acupressure point.
Category
Treatment - Other
2
Description
Control group (group non-acupressure massage): In other parts of acupressure was performed. With the non-acupressure are 3-1 CUN (Chinese unit of length) away from the acupressure (Shenmen, Yintang), so that in the direction of energy flow is not. The massage ball with a diameter of one centimeter with an average of 25-20 cycles per minute for 10 minutes was performed. Amount of pressure was at 4-3 kg, So that they feel the pressure, but do not feel pain in acupressure point.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center of Kashan University of Medical Sciences
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 University of Medical Sciences
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 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
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD, Director of Journal Feyz 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
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD, Director of Journal Feyz Department
Other areas of specialty/work
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
Email
Taghadosi.m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD, Director of Journal Feyz
Other areas of specialty/work
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
Email
Taghadosi.m@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)