Protocol summary

Summary
Anxiety is one of the factors that increases mortality risk in the patients with heart disease. The aim of this study is The effect of acupressure on anxiety of patients candidate for coronary angiography in selected AJA hospital. Design of this study is a randomized controlled clinical trial. A total of 60 patients with age of 35-80 years old; without history of use of acupressure, previous history of angiography of coronary vessel, mental illnesses, drug addiction, anatomical and skin problem in P6 point and Thumb of two hands; being literate were selected and randomly divided in two groups: intervention group who received pressure on the P6 point of two hands (first right then left hand); Control group who received pressure on the Thumb of two hands. The interventions were performed on the morning angiography. In order to data collection, at the before and 30 min after intervention spielberger state anxiety questionnaire was filled out by the patients and physiologic criteria were assessed by the nurse. In this study, primary outcome measure is anxiety and secondary outcome measures are blood pressure, pulse, respiration.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062118178N1
Registration date: 2014-11-13, 1393/08/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-13, 1393/08/22
Registrant information
Name
Narges Choopani Ab bakhsh
Name of organization / entity
AJA medical university
Country
Iran (Islamic Republic of)
Phone
+98 77500929
Email address
n_rajai@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA Nursing Faculty
Expected recruitment start date
2014-04-14, 1393/01/25
Expected recruitment end date
2014-05-15, 1393/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on anxiety of patients candidate for coronary angiography in selected AJA hospital
Public title
The effect of acupressure on anxiety of patients candidate for coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being 35-80 years old and literated and without history of use of acupressure, previous history of angiography of coronary vessel, mental illnesses, drug addiction, anatomical and skin problem in P6 point and Thumb of two hands exclusion criteria: If patients are clinically ill and dont have stable hemodynamic condition, The patient does not want to continue participating in the study
Age
From 35 years old to 80 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
Next to Emam Reza hospital, Eatemadzade avenue, Fatemi avenue
City
Tehran
Postal code
Approval date
2014-07-13, 1393/04/22
Ethics committee reference number
9310

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
anxiety
Timepoint
before intervention and half hour after finishing that
Method of measurement
spielberger state anxiety questionnaire

Secondary outcomes

1

Description
pulse rate
Timepoint
before intervention and half hour after that
Method of measurement
before intervention and half hour after that

2

Description
blood pressure
Timepoint
before intervention and half hour after that
Method of measurement
before intervention and half hour after that

3

Description
respiratory rate
Timepoint
before intervention and half hour after that
Method of measurement
before intervention and half hour after that

Intervention groups

1

Description
intervention group receives pressure on the P6 point of two hands for 10 minutes. The intervention is performed on the morning angiography (first right hand then left hand)
Category
N/A

2

Description
Control group who received pressure on the Thumb of two hands for 10 minutes. The intervention is performed on the morning angiography (first right hand then left hand)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA Faculty of Nursing
Full name of responsible person
Dr Armin Zareian
Street address
next to the Family hospital, kaj street, Shariati street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA Faculty of Nursing
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
AJA Faculty of Nursing
Full name of responsible person
Narges Choopani Ab bakhsh
Position
MS Critical care nursing student
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
n.choopani@yahoo.co
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA Faculty of Nursing
Full name of responsible person
Narges Choopani Ab bakhsh
Position
MS Critical care nursin student
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
n.choopani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
AJA Faculty of Nursing
Full name of responsible person
Narges Choopani Ab bakhsh
Position
MS critical care nursin student
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
n.choopani@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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