Protocol summary

Summary
Objectives: The aim of this study is to determine the effect of guided imagery on anxiety among elderly patients undergoing coronary artery angiography. Design: This study is a non-blinding randomized controlled trial. Setting and conduct: The study environment is coronary artery angiography department of Amiralmomenin Hospital in Kordkuy. Participants: 70 patients candidate for coronary artery angiography are divided into two groups: intervention (35 persons) and control (35 persons) using random number table. Inclusion criteria: Over 60 years old; avoiding the use of drugs that affect the mental state;; no history of coronary artery angiography and cardiovascular surgery. Exclusion criteria: unable to communicate. Intervention: The experimental group will receive 12-minute audio file with headphones that will be played privately before coronary artery angiography. The control group will pass the routine process of angiography department. The questionnaire will be completed in three steps in both groups: twice before and once after coronary artery angiography. Outcome variable: The anxiety of patients under coronary artery angiography

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111528101N4
Registration date: 2017-02-09, 1395/11/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Zohreh Taraghi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ztaraghi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-11-07, 1395/08/17
Expected recruitment end date
2016-12-07, 1395/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of guided imagery on anxiety among elderly patients undergoing coronary artery angiography
Public title
anxiety in coronary artery angiography
Purpose
Supportive
Inclusion/Exclusion criteria
. Inclusion criteria: Over 60 years old; avoiding the use of drugs that affect the mental state; no cognitive problems based on the rating of 7 or higher in Abbreviated Mental Test (AMT); no history of coronary artery angiography and cardiovascular surgery and a minimum score of 1 and a maximum of 20 in Geriatric Anxiety Scale(GAS). Exclusion criteria: Hearing impairment; unable to communicate.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
ٍEthics Committee of Mazandaran University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Approval date
2016-11-07, 1395/08/17
Ethics committee reference number
IR.MAZUMS.REC.95.2402

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
anxiety
Timepoint
before intervention-after intervention- after coronary artery angiography
Method of measurement
GAS questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: The experimental group will receive 12-minute audio file with headphones that will be played privately before coronary artery angiography. The questionnaire will be completed in three steps in both groups: twice before and once after coronary artery angiography.
Category
Behavior

2

Description
Control: The control group will pass the routine process of angiography department.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital of Kordkuy
Full name of responsible person
Doctor Mehdi Zahedi
Street address
Golestan - Kordkuy - Forest street
City
Kordkoy

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
َAhmad Ali Enayati
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Ali Nikakhtar
Position
Master Student in Geriatric nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Phone
+98 11 4208 1104
Fax
Email
s.ali.nikakhta@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Taraghi
Position
Assisstant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Phone
+98 11 3379 5585
Fax
Email
ztaraghi@mazums.ac.ir; ztarair@gmail.com www.mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Ali Nikakhtar
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4881934771
Phone
+98 17 3434 8218
Fax
Email
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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