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Comparison of the effect of guided imagery with diaphragmatic breathing on anxiety in patients scheduled for coronary angiography

Protocol summary

Study aim
Determining and comparing the effects of guided imagery and diaphragmatic breathing on anxiety in patients candidate for coronary angiography
Design
This is a randomized clinical trial with a control group and parallel group design, without blinding, using block randomization, with a total sample size of 90 patients.
Settings and conduct
This study will be conducted at Shahid Rajaie Cardiovascular Institute on patients who are candidates for coronary angiography, including two intervention groups and one control group. A demographic questionnaire will be completed by all three groups prior to angiography. The Hospital Anxiety and Depression Scale (HADS–Anxiety) questionnaire will be completed by the three groups before and after the intervention. In addition, heart rate and blood pressure will be measured before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years; willingness to cooperate; full consciousness; ability to read and write; being a candidate for coronary angiography. Exclusion criteria: Hearing problem; Use of anti-anxiety medications in the past 6 months; History of psychiatric illness; Substance addiction; Use of stress reduction methods before the start of this study; Patients with moderate to severe anxiety.
Intervention groups
Intervention group 1: The diaphragmatic breathing group will listen to an audio file teaching diaphragmatic breathing one hour prior to angiography. Intervention group 2: The guided imagery group will listen to a guided imagery audio file one hour prior to angiography. Control group: The control group will receive routine care.
Main outcome variables
Anxiety, heart rate, blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250715066498N1
Registration date: 2025-09-14, 1404/06/23
Registration timing: prospective

Last update: 2025-09-14, 1404/06/23
Update count: 0
Registration date
2025-09-14, 1404/06/23
Registrant information
Name
Zeinab Khorshidi Nikbin
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 2416
Email address
f.shabani@rhi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of guided imagery with diaphragmatic breathing on anxiety in patients scheduled for coronary angiography
Public title
Comparison of guided imagery and diaphragmatic breathing on anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Willingness to cooperate Full alertness Literacy in reading and writing Candidate for coronary angiography
Exclusion criteria:
Hearing problem Use of anti-anxiety medications in the past 6 months History of psychiatric illness Substance addiction Use of stress reduction methods before the start of this study Patients with moderate to severe anxiety
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method with blocks of size three was applied, with a total sample size of 30 participants in each of the three groups (Diaphragmatic Breathing [A], Guided Imagery [B], and Control [C]), resulting in 90 participants overall. A total of 30 blocks of three participants each were used. Within each block, the three participants were randomly assigned to the three groups so that each group received exactly one participant per block. The possible allocations for each block were the six permutations: (A, B, C), (A, C, B), (B, A, C), (B, C, A), (C, A, B), and (C, B, A). One of these permutations was then randomly selected using a random number table.
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
The Ethics Committee of Shahid Rajaei Cardiovascular Medical and Research Center
Street address
Ministry of Health and Medical Education, Central Headquarters, Block A, 13th Floor, Simaye Iran St., Shahrak-e Gharb (Qods), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2025-07-07, 1404/04/16
Ethics committee reference number
IR.RHC.REC.1404.067

Health conditions studied

1

Description of health condition studied
Patients who are candidates for coronary angiography
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Anxiety is measured before and after the intervention of diaphragmatic breathing and guided imagery. It is also measured before and after routine care in the control group
Method of measurement
Anxiety is evaluated through the Hospital Anxiety and Depression Scale (HADS) questionnaire.

2

Description
Blood pressure measurement
Timepoint
Blood pressure will be measured before and after the interventions of diaphragmatic breathing and guided imagery. It will also be measured before and after routine care in the control group.
Method of measurement
using manual blood pressure monitor

3

Description
Heart rate
Timepoint
Heart rate will be measured before and after the interventions of diaphragmatic breathing and guided imagery. It will also be measured before and after routine care in the control group.
Method of measurement
Pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The diaphragmatic breathing group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist's guided instructions, soothing music, and step-by-step diaphragmatic breathing training. After the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured.
Category
Other

2

Description
Intervention group 2: The guided imagery group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist’s guided instructions, soothing music, and step-by-step guided imagery training. Following the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured.
Category
Other

3

Description
Control group: The control group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will receive routine care. Following the routine care, the anxiety questionnaire, heart rate, and blood pressure will be measured again.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
Zeynab Khorshidi Nikbin
Street address
Shahid Rajaei Medical, Research, and Educational Cardiovascular Center; Corner of Niayesh and Vali Asr (A.S.) Street; Next to Mellat Park; Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
khbehnaz1996@gmail.com
Web page address
https://www.rhc.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center
Full name of responsible person
Dr. Saeedeh Mazloumzadeh
Street address
Shahid Rajaei Medical, Research, and Educational Cardiovascular Center; Corner of Niayesh and Vali Asr (A.S.) Street; Next to Mellat Park; Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
info@rhi.ac.ir
Web page address
https://www.rhc.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center
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
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center
Full name of responsible person
Zeynab Khorshidi Nikbin
Position
Master’s student in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center Corner of Niayesh and Vali Asr (A.S.) Street, Next to Mellat Park, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
khbehnaz1996@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center
Full name of responsible person
Zeynab Khorshidi Nikbin
Position
Master’s student in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center Corner of Niayesh and Vali Asr (A.S.) Street, Next to Mellat Park, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
khbehnaz1996@gmail.com
Web page address
https://www.rhc.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center
Full name of responsible person
Zeynab Khorshidi Nikbin
Position
Master’s student in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Cardiovascular Medical, Research, and Educational Center Corner of Niayesh and Vali Asr (A.S.) Street, Next to Mellat Park, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
khbehnaz1996@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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