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Investigating the effect of guided imagery on anxiety and physiologic Parameters of patients candidate for Coronary Computed Tomography Angiography

Protocol summary

Study aim
Determining the effect of guided imagery on anxiety and physiological indicators of patients candidates for coronary computed tomography angiography
Design
Clinical trial with control group with parallel groups, randomized phase 3 on two groups of 32 people, where random allocation of samples will be done through the sealed envelope site.
Settings and conduct
The study will be conducted in the radiology department of Kosar hospital of Semnan on patients referred for coronary computed tomography using the State and Trait Spielberger anxiety Questionnaire before and after playing an eight-minute audio file of guided imagery through headphones.
Participants/Inclusion and exclusion criteria
Major inclusion conditions before randomization: First visit for computed tomography, Age range 30-80 years, Body weight less than 100 kg, Having minimum literacy in reading and writing Farsi and No hearing problems Major exclusion conditions before randomization: History of drug abuse, Having a known anxiety disorder and Taking anti-anxiety and sedative drugs in the last 24 hours
Intervention groups
Intervention group: First, blood pressure, pulse and percentage of oxygen saturation are measured . Then, Spielberger State-Trait questionnaire will be completed by each patients, and immediately after that, the guided imagery audio clip will be played for them through headphones, and immediately after it is finished, measurements and completing the questionnaire are done for the second time. Control group: First, blood pressure, pulse and percentage of oxygen saturation are measured from the left arm while lying on the back. Then, Spielberger's State-Trait anxiety questionnaire will be completed by each patients, and immediately after eight minutes, measurements and completing the questionnaire are done for the second time.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20140721018550N13
Registration date: 2024-02-11, 1402/11/22
Registration timing: prospective

Last update: 2024-02-11, 1402/11/22
Update count: 0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of guided imagery on anxiety and physiologic Parameters of patients candidate for Coronary Computed Tomography Angiography
Public title
Investigating the effect of guided imagery on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
First visit for computed tomography Age range 30-80 years Body weight less than 100 kg Having minimum literacy in reading and writing Farsi No hearing problems
Exclusion criteria:
History of drug use Having a known anxiety disorder Taking anti-anxiety and sedative drugs in the last 24 hours
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to the intervention and control groups will be based on random allocation and with blocks of eight with age (30 to 55 years and 56 to 80 years) and gender (male and female) blocks randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical sciences, Basij Bolverd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SEMUMS.REC.1402.233

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
100-199
ICD-10 code description
Diseases of the circulatory system

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory

Secondary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
ِDigital Arm Spyghmomanometer (Easy Life brand)

2

Description
Pulse rate
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter (Bitmos brand)

3

Description
Mean Arterial pressure
Timepoint
Before and after intervention
Method of measurement
MAP= (SBP + 2DBP)/3

4

Description
O2 saturation %
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter (Bitmos brand)

Intervention groups

1

Description
Intervention group: Intervention group: First, blood pressure, pulse and percentage of oxygen saturation are measured from the left arm while lying on the back. Then, Spielberger State-Trait questionnaire will be completed by each patients, and immediately after that, the guided imagery audio clip will be played for them through headphones, and immediately after it is finished, blood pressure, pulse and percentage Oxygen saturation will be measured for second time and the Spielberger State questionnaire will be answered by each patients.
Category
Other

2

Description
Control group: Control group: Control group: First, blood pressure, pulse and percentage of oxygen saturation are measured from the left arm while lying on the back. Then, Spielberger's State-Trait anxiety questionnaire will be completed by each patients, and immediately after that, subjects lying on the back for the time equivalent to applying the intervention for the intervention group, and immediately after that, blood pressure, pulse and percentage Oxygen saturation will be measured for second time and the Spielberger State questionnaire will be answered by each patients.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Koosar hospital of Semnan
Full name of responsible person
Mohammad Forozeshfard
Street address
Amin St., Nirogah Square, Golestan Town, Semnan, Semnan Province, Iran
City
Semnan
Province
Semnan
Postal code
99558- 35198
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
ِDeputy of Research and Technology, Semnan University of Medical sciences, Basij Boulevard, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Web page address
https://.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+982333448996-8
Fax
+98 23 3365 4209
Email
nr_dana@yahoo.com
Web page address
https://semums.ac.ir/FacultyMembers

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+982333448996-8
Fax
+98 23 3344 8999
Email
nr_dana@yahoo.com
Web page address
https://semums.ac.ir/FacultyMembers

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4190
Email
nr_dana@yahoo.com
Web page address
https://semums.ac.ir/FacultyMembers

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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