Effect of guided imagery on the anxiety and vital signs of patients candidate for electrophysiologic study
Design
Parallel group, single blind, randomized controlled trial
Settings and conduct
The study is randomized clinical trial performing on patients undergoing cardiac electrophysiologic study in Dr.Heshmat Hospital in Rasht
Participants/Inclusion and exclusion criteria
Entry criteria 1) age between 20-60 ; 2) minimum reading and writing literacy; 3) not having vision and hearing impairment; 4) lack of addiction to opium, sedatives and alcohol; 5)undergoing cardiac electrophysiologic study for the first time, 6) anxiety score less than 64 in the open anxiety scale and anxiety score less than 62 in the hidden anxiety scale
Exclusion criteria 1) patient's dissatisfaction for continuation of study; 2)use of sedatives within the last 24 hours, 3) serious complications such as critical arrhythmias ; 4) no experience of relaxation and guided imagary; 5)having degree in psychology and related fields; 6) having bitter memory of sea
Intervention groups
For individuals in the intervention group, one day and also one hour before going to the cardiac electrophysiologic study room, a audio CD of guided imagary, which includes imagination of beautiful and pleasant scenery(Seafront) was played for 18 minutes through headphones.
To control intruders such as noise in the ward,intervention was performed in the patient's room and without the presence of the researcher,in an enclosed room with folding screen between beds.The control group will receive only routine care and nursing instructions and training during treatment
Main outcome variables
Anxiety & vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N2
Registration date:2018-06-15, 1397/03/25
Registration timing:prospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Guided Imagery on Anxiety & vital signs in patients undergoing Cardiac Electrophysiologic study
Public title
Effect of Guided Imagery on Anxiety & vital signs in patients undergoing Cardiac Electrophysiologic study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
entry criteria 1) age between 20-60 ; 2) minimum reading and writing literacy; 3) not having vision and hearing impairment; 4) lack of addiction to opium, sedatives and alcohol; 5)undergoing cardiac electrophysiologic study for the first time, 6) anxiety score less than 64 in the open anxiety scale and anxiety score less than 62 in the hidden anxiety scale
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks are made by quadruple random allocation.To determine the alternate selection of blocks,14 different random numbers are generated by randomized numbers table and the sequence of random assignments of the samples are generated by the statistics specialist. Each of the 52 random assignments is written on a card and packaged in a non-transparent closed envelope given to the collaborator researcher, who doesn't interfere in sampling and evaluation of the samples,in the hospital. At the arrival of each patient, the relevant envelope will be opened and the patient allocation group will be informed to the researcher for intervention and basic evaluations
Blinding (investigator's opinion)
Single blinded
Blinding description
Principal investigator
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.GUMS.REC.1397.055
Health conditions studied
1
Description of health condition studied
Patients Candidate Heart Electrophysiology Study
ICD-10 code
I44
ICD-10 code description
Atrioventricular and left bundle-branch block
Primary outcomes
1
Description
Anxiety
Timepoint
One day and also one hour before going to the cardiac electrophysiologic study room
Method of measurement
Spilberger's apparent and hidden anxiety questionnaire
2
Description
vital signs
Timepoint
The effect of audio CD of guided imagary, one day and also one hour before going to the cardiac electrophysiologic study room
Method of measurement
vital signs (heart rate, respiratory rate, blood pressure, temperature) are measured by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For individuals in the intervention group, one day and also one hour before going to the cardiac electrophysiologic study room, a audio CD of guided imagary, which includes imagination of beautiful and pleasant scenery(Seafront) was played for 18 minutes through headphones.To control intruders such as noise in the ward,intervention was performed in the patient's room and without the presence of the researcher,in an enclosed room with folding screen between beds.The control group will receive only routine care and nursing instructions and training during treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Rasht Hospital
Full name of responsible person
zahra ahmadnia
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Fax
+98 31 3361 8177
Email
zahmadnia@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
shadman nemati
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 31 3333 2058
Email
zahmadnia@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
zahmadnia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
zahmadnia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
zahmadnia@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
For individuals in the intervention group, one day and also one hour before going to the cardiac electrophysiologic study room, a audio CD of guided imagary, which includes imagination of beautiful and pleasant scenery(Seafront) was played for 18 minutes through headphones.
To control intruders such as noise in the ward,intervention was performed in the patient's room and without the presence of the researcher,in an enclosed room with folding screen between beds.The control group will receive only routine care and nursing instructions and training during treatment
When the data will become available and for how long
one day and also one hour before going to the cardiac electrophysiologic study room
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
From where data/document is obtainable
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
What processes are involved for a request to access data/document