Protocol summary
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Study aim
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The effect of controlled breathing on the anxiety and fear of patients candidate for coronary angiography admitted to Shahid Sadoughi Hospital, Yazd, in 1396
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Design
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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).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Anxiety; Fear
General information
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-27, 1397/11/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shahid Sadoughi University Of Medical Sciences Yazd
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Expected recruitment start date
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2019-02-20, 1397/12/01
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Expected recruitment end date
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2019-06-22, 1398/04/01
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Actual recruitment start date
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2019-02-20, 1397/12/01
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Actual recruitment end date
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2019-06-22, 1398/04/01
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Trial completion date
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2019-07-21, 1398/04/30
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Scientific title
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The effect of controlled breathing on anxiety and fear in patients undergoing coronary angiography
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Public title
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ٍffect of controlled breathing on anxiety and fear in coronary angiography
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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)
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-19, 1396/05/28
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Ethics committee reference number
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IR.SSU.REC.1396.72
Health conditions studied
1
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Description of health condition studied
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Angina pectoris
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ICD-10 code
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I20
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ICD-10 code description
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Angina pectoris
Primary outcomes
1
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Description
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anxiety
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Timepoint
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Immediately before intervention and immediately after intervention (both cases before performing angiography)
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Method of measurement
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Spielberger positional anxiety questionnaire
2
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Description
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fear
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Timepoint
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Immediately before intervention, five minutes after angiography and one day after angiography
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Method of measurement
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Using the VAS benchmark
Secondary outcomes
1
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Description
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Heart rate
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Timepoint
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Immediately before intervention, five minutes after angiography
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Method of measurement
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Physical exam
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: There is no intervention in the control group.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A portion of the data including main and secondary outcomes will be shared.
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When the data will become available and for how long
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The relevant data will be available one year after the publication of the results.
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To whom data/document is available
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Data will be available to all groups that have the scientific capabilities of the data.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Ekham Akhondzadeh
tel: 00989137790427
E mail: e.akhondzadeh@ssu.ac.ir
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What processes are involved for a request to access data/document
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Documentation will be provided to the applicant immediately after the submit application and the phone call or e-mail.
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Comments
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