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The effect of controlled breathing on anxiety and fear in patients undergoing coronary angiography

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History
# Registration date Revision Id
2 2021-03-12, 1399/12/22 175895
1 2019-01-27, 1397/11/07 77019
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  • General information

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    80
    2017-07-23, 1396/05/01
    2019-02-20, 1397/12/01
    2017-12-14, 1396/09/23
    2019-06-22, 1398/04/01
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    2019-02-20, 1397/12/01
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    2019-06-22, 1398/04/01
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    2019-07-21, 1398/04/30
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    Dear Editor In Chief The start date of my sampling was 05/01/2017 and the end date of my sampling was 01/09/2017. Unfortunately, due to repeated corrections, the final date of registration in the system was 11/07/1397. And now, unfortunately, I have trouble publishing the article. And the only problem mentioned is the registration date and I can not print anywhere. Please pay the necessary attention Thank you regards
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    با احترام تاریخ شروع نمونه گیری اینجانب 1396/05/01 و تاریخ اتمام نمونه گیری بنده 1396/09/01 ثبت شده بوده است. ولی متاسفانه به دلیل اصلاحیه های مکرر تاریخ نهایی ثبت در سامانه 1397/11/07 بوده است. و در حال حاضر متاسفانه جهت چاپ مقاله به مشکل برخورده ام. و تنها مشکل ذکر شده تاریخ ثبت اعلام میشود و قادر به چاپ در هیچ کجا نیستم . لطفا توجهات لازم را مبذول فرمایید از لطف شماسپاسگزارم
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  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Sadoughi Hospital Yazd
    Name of recruitment center - Persian: بیمارستان شهیدصدوقی یزد
    Full name of responsible person - English: Elham Akhondzadeh
    Full name of responsible person - Persian: الهام آخوندزاده
    Street address - English: Shahid Sadoughi Hospital, Ebne sina Evenue, Shahid Ghandi BLVD, Yazd, Iran
    Street address - Persian: یزد- بلوار شهید قندی- خیابان ابن سینا- بیمارستان شهید صدوقی یزد
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 4100
    Fax:
    Email: e.akhondzadeh@ssu.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Sadoughi Hospital Yazd
    Name of recruitment center - Persian: بیمارستان شهیدصدوقی یزد
    Full name of responsible person - English: Elham Akhondzadeh
    Full name of responsible person - Persian: الهام آخوندزاده
    Street address - English: Shahid Sadoughi Hospital, Ebne sina Evenue, Shahid Ghandi BLVD, Yazd, Iran
    Street address - Persian: یزد- بلوار شهید قندی- خیابان ابن سینا- بیمارستان شهید صدوقی یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 4100
    Fax:
    Email: e.akhondzadeh@ssu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research of Yazd Shahid sadoughi University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهیدصدوقی یزد
    Full name of responsible person - English: Research deputy
    Full name of responsible person - Persian: معاونت پژوهشی
    Street address - English: Bahonar Square, Central office of Shahid Sadoughi University of Medical Sciences, Yazd
    Street address - Persian: میدان با هنر، ساختمان مرکزی دانشگاه علوم پزشکی شهیدصدوقی، یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: info@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهیدصدوقی یزد
    Full name of responsible person - English: Research deputy
    Full name of responsible person - Persian: معاونت پژوهشی
    Street address - English: Bahonar Square, Central office of Shahid Sadoughi University of Medical Sciences, Yazd
    Street address - Persian: میدان با هنر، ساختمان مرکزی دانشگاه علوم پزشکی شهیدصدوقی، یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: info@ssu.ac.ir
    Web page address:

Protocol summary

Study aim
The effect of controlled breathing on the anxiety and fear of patients candidate for coronary angiography admitted to Shahid Sadoughi Hospital, Yazd, in 1396
Design
This is a clinical trial study. The research community are all patients admitted to Shahid Sadoughi Hospital in Yazd for angiography. Among the research community, 80 patients select and divide randomly into two groups (case and control group).
Settings and conduct
In this study, a two-part questionnaire is used, the first part consists of demographic variables including age, sex, level of education and marital status. The second part relates to Spilberger's Situational Anxiety Questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Informed consent - Age over 18 years - Ability to read and write in Persian language - GCS: 15 Exclusion criteria: - Having angiography history - Use of invasive methods, such as echocardiography from the esophagus before angiography - having heart valve disease, acute myocardial infarction and acute coronary syndrome - Neuropathy and Delirium - The presence of psychiatric disorders, the continued use of muscle relaxant, hypnotic, psychoactive and anxiolytic drugs in the last 6 months, according to the patient. - Drug addiction
Intervention groups
Control group: This group undergo Angiography without any training in controlled breathing. Intervention group: In this group, controlled breathing is trained and this breathing perform by the patients for 10 minutes before and also throughout the Angiography.
Main outcome variables
Anxiety; Fear

General information

Reason for update
Dear Editor In Chief The start date of my sampling was 05/01/2017 and the end date of my sampling was 01/09/2017. Unfortunately, due to repeated corrections, the final date of registration in the system was 11/07/1397. And now, unfortunately, I have trouble publishing the article. And the only problem mentioned is the registration date and I can not print anywhere. Please pay the necessary attention Thank you regards
Acronym
IRCT registration information
IRCT registration number: IRCT20170701034825N2
Registration date: 2019-01-27, 1397/11/07
Registration timing: prospective

Last update: 2021-03-21, 1400/01/01
Update count: 1
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
elham akhoondzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 0539
Email address
e.akhondzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University Of Medical Sciences Yazd
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-07-21, 1398/04/30
Scientific title
The effect of controlled breathing on anxiety and fear in patients undergoing coronary angiography
Public title
ٍffect of controlled breathing on anxiety and fear in coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Age over 18 years Candidate for angiography Ability to read and write in Persian GCS: 15
Exclusion criteria:
Having angiography history- Use of invasive methods, such as echocardiography from the esophagus before angiography having heart valve disease, acute myocardial infarction and acute coronary syndrome Neuropathy and Delirium The presence of psychiatric disorders the continued use of muscle relaxant, hypnotic, psychoactive and anxiolytic drugs in the last 6 months, according to the patient Drug addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After random sampling using table of random numbers among all eligible patients admitted to Shahid Sadoughi hospital in Yazd for angiography, research objectives are explained telephone and it is mentioned that they may be in the intervention or control group. then patients are divided randomly into two intervention and control groups (each of the groups 40 patients)
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
Shahid Sadoughi University of Medical Sciences Yazd
Street address
Bahonar square
City
Yazd
Province
Yazd
Postal code
8915887857
Approval date
2017-08-19, 1396/05/28
Ethics committee reference number
IR.SSU.REC.1396.72

Health conditions studied

1

Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris

Primary outcomes

1

Description
anxiety
Timepoint
Immediately before intervention and immediately after intervention (both cases before performing angiography)
Method of measurement
Spielberger positional anxiety questionnaire

2

Description
fear
Timepoint
Immediately before intervention, five minutes after angiography and one day after angiography
Method of measurement
Using the VAS benchmark

Secondary outcomes

1

Description
Heart rate
Timepoint
Immediately before intervention, five minutes after angiography
Method of measurement
Physical exam

Intervention groups

1

Description
After a controlled breathing training, the participants in the intervention group are requested to use twenty minutes controlled breathing prior to angiography for ten minutes, as well as throughout the course of angiography. So they must inhale in 2 seconds, counting 1001, 1002 and exhale in 3 seconds, counting 1001, 1002, 1003 in their mind.
Category
Prevention

2

Description
Control group: There is no intervention in the control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital Yazd
Full name of responsible person
Elham Akhondzadeh
Street address
Shahid Sadoughi Hospital, Ebne sina Evenue, Shahid Ghandi BLVD, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4100
Email
e.akhondzadeh@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Research deputy
Street address
Bahonar Square, Central office of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
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 of Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Elham Akhoondzadeh
Position
Master degree nursing specialist student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 521, Shahid Ahmadi Roshan apartment, Safaie, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3525 0539
Fax
Email
e.akhondzadeh@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mostafa Javadi
Position
Ph.d. in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
College of Nursing Midwifery, Yazd Shahid sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
Email
javadinurse@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Elham Akhoondzadeh
Position
M.A Student of intensive care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Boo Ali line, Timsar Fallahi street,Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 356284108
Fax
Email
e.akhondzadeh@ssu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data including main and secondary outcomes will be shared.
When the data will become available and for how long
The relevant data will be available one year after the publication of the results.
To whom data/document is available
Data will be available to all groups that have the scientific capabilities of the data.
Under which criteria data/document could be used
If a person wants to have a similar study, he needs to have the data in this study. If a person intends to use the data from this study as an applied therapeutic topic.
From where data/document is obtainable
Ekham Akhondzadeh tel: 00989137790427 E mail: e.akhondzadeh@ssu.ac.ir
What processes are involved for a request to access data/document
Documentation will be provided to the applicant immediately after the submit application and the phone call or e-mail.
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