1. Home
  2. Approved trials
  3. » فارسی

The effects of guided imagery on anxiety and physiological parameters in patients with acute coronary syndrome admitted to the cardiac intensive care unit: A randomized controlled clinical trial

Protocol summary

Summary
The purpose of this study is to determine the effects of Guided Imagery on anxiety and physiological parameters in patients with acute coronary syndrome admitted to the cardiac intensive care unit. This is a single center-randomized study and population will be patients with acute coronary syndrome admitted to the cardiac intensive care unit. Inclusion criteria include patients agreed to participate in the study, the definitive diagnosis based on clinical symptoms, ECG and Cardiologist’ visit, suffering a heart attack for the first time (previously not admitted to the CCU), aged between 30 and 80 years. Exclusion criteria include the patient's lack of consent to continue, treatment of arrhythmia during the intervention and performing CPR on a patient during the intervention. After the ethics committee approval and permission from the 22- Bahman hospital authorities, the informed consent form will be given to the patients and the purpose of the research will be explained within 5 minutes for them. Then informed consent and demographic form will be completed by the participants. The intervention will be started at the beginning of the hospitalization. Thus intervention group in addition to usual care, 2 times a day in the morning (between 8 and 10) and night (between 20 and 22) will listen to the Guided Imagery CD which is prepared by the researcher by using a CD player and headphones for 18 minutes. The CD contains sentences to visualize the beautiful scenery (beach), pleasant scenes and positive phrases to decrease anxiety. To control interfering factors and increase accuracy of visualization, researcher will be present at all meetings. The control group will receive only routine care. Spielberger questionnaire on the first day and the last day before the intervention will be used. Also physiological parameters such as blood pressure, respiration, heart rate and oxygen saturation before and after intervention will be measured using Monitoring. Anxiety and pain will be measured before and after each intervention. The effects of Guided Imagery, the main variable, will be measured on anxiety and physiological parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031016919N1
Registration date: 2014-10-22, 1393/07/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-22, 1393/07/30
Registrant information
Name
Mahdi Pahlavan
Name of organization / entity
Gonabad university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3733 3676
Email address
pahlavan.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The research will be done by personal expenditure
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of guided imagery on anxiety and physiological parameters in patients with acute coronary syndrome admitted to the cardiac intensive care unit: A randomized controlled clinical trial
Public title
Guided Imagery for Anxiety Reduction in Cardiac Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-patients agree to participate in the study 2- the definitive diagnosis based on clinical symptoms, ECG and Cardiologist’ visit 3- suffering a heart attack for the first time (previously not admitted to the CCU) 4- aged between 30 and 80 years 5- not using anti-arrhythmic drugs during hospitalization, 6- heart disease history between 6 months and 5 years 7- not having mental illnesses, including delusions, hallucinations, and so on 8- not being admitted in CPR 9- patient must be fully conscious and able to answer questions 10- not having family history of sudden death due to heart disease 11- physician confirms that the patient is able to perform the procedure. Exclusion criteria: 1- the patient's lack of consent to continue 2- treatment of arrhythmia during the intervention 3- performing CPR on patient during the intervention 4- heart attack that result in cardiac bypass surgery or angioplasty 5- other serious physical illness that reduce life expectancy.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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 Gonabad University of Medical Sciences.
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
GMU.REC.1392.58

Health conditions studied

1

Description of health condition studied
acute coronary syndrome
ICD-10 code
124.8
ICD-10 code description
Other forms of acute ischaemic heart disease

Primary outcomes

1

Description
physiological parameters blood pressure, respiration, heart rate and oxygen saturation
Timepoint
before and after each intervention
Method of measurement
using Monitoring

2

Description
Anxiety
Timepoint
before and after each intervention
Method of measurement
Visual analogue of anxiety

3

Description
Pain
Timepoint
before and after each intervention
Method of measurement
Visual analogue of pain

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group in addition to usual care, 2 times a day in the morning (between 8 and 10) and night (between 20 and 22) will listen to the Guided Imagery CD which is prepared by the researcher by using a CD player and headphones for 18 minutes.
Category
Other

2

Description
The control group will receive only routine care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad hospital of 22 Bahman
Full name of responsible person
Mahdi Pahlavan
Street address
Gonabad University of Medical Sciences
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Street address
Gonabad University of Medical Sciences
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Pahlavan
Position
MSC of student critical care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 53 3723 1113
Fax
Email
pahlavan.m@gmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Doctor Jahanshir Tavakkolizade
Position
Associate prof.
Other areas of specialty/work
Street address
The next of the Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
Email
jahanshir_t@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Pahlavan
Position
MSc student of critical care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
9694135675
Phone
+98 53 3733 3676
Fax
Email
pahlavanvije1390@gmail.compahlavan.m@gmu.ac.ir
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
Loading...