Protocol summary

Summary
Patients in the intervention group ( 37 cases) and control group ( 37 cases) will participate in the study and randomly assigned based on the type of work that is purposeful sampling test and control groups based on number of patient cases will be ( allottable interventional bronchoscopy unit is done by a nurse who is not aware of ) , and given that the waiting time per patient for 18-24 hours is bronchoscopic sampling parallel intervention study will be the after going through the sample survey , the researcher first demographic questionnaire and through interviews with patients and case studies will be completed. The questionnaire contained a number of questions regarding demographic information and some questions about health and disease. Then, if the study consent form to participate in the study, the researcher first read it , and if the patient gives consent for participation in the study had to sign . After patient selection and consent to the study, patients entered the study . Then the researchers compared the intervention and control groups for all the subjects are unaware of information that includes blood pressure , pulse and respiration per minute ( prior consultation ) and the STAI anxiety questionnaire before consultation through interviews will be completed . Three patients in the test group for 30 minutes in clinical research will be consulting with him . Individual counseling and face-to- face. Consultation on the advice nurse and includes an explanation of all the circumstances before, during and after bronchoscopy, which includes training preparation before the procedure ( diet , drugs , etc.) during bronchoscopy ( full explanation about the What will be done during bronchoscopy ) and after bronchoscopy ( explaining that after bronchoscopy will be faced with the possible problems and solutions ) , patient awareness about the benefits and risks of the patient the opportunity to express feelings, questions , selecting appropriate ways to reduce anxiety and increase tolerance, procedures , and answers to questions posed by the patient. Component in the control group patients also do all of these steps can be done in consultation with the patient . The next day , the researcher before the procedure information for all participants , including blood pressure , pulse rate and respiratory STAI state anxiety questionnaire is to be completed .groups will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123011936N1
Registration date: 2013-04-27, 1392/02/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-04-27, 1392/02/07
Registrant information
Name
Mahmoud Amiri
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 5182
Email address
mahmood.amiri18@yahoo.com
Recruitment status
Recruitment complete
Funding source
Student Research Committee, Shahed University
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing consultation on anxiety, tolerance and satisfaction in patients undergoing bronchoscopy, Imam Khomeini Hospital, Tehran in 2012-2013
Public title
Effect of nurse counseling program on anxiety and satisfaction in patients undergoing bronchoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 18 to 70 years old; the ability to understand Persian languages; lack of vision impairment as being able to select the correct location in the VAS (Visual analogue scale) to measure satisfaction; lacking a history of previous bronchoscopy and lack of disease is high blood pressure or a history of antihypertensive drugs. Exclusion criteria: canceled bronchoscopic day set other than to cause patient anxiety and the patient withdrawal from the study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahed University
Street address
Tehran - Gulf Freeway - opposite the shrine of Imam Khomeini
City
Tehran
Postal code
3319118651
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
41/166744

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention - a day after the intervention (before the procedure)
Method of measurement
Spielberger standard questionnaire

Secondary outcomes

1

Description
Satisfaction
Timepoint
After bronchoscopic
Method of measurement
Visual Analogue Scale measuring satisfaction

2

Description
Level of tolerance
Timepoint
After the bronchoscopy
Method of measurement
4 item Likert scale

3

Description
Comfort level
Timepoint
After the bronchoscopy
Method of measurement
Comfort level of the numerical scale (1 comfort lowest, 10 the highest level of comfort)

4

Description
Level of cooperation during bronchoscopy
Timepoint
After the bronchoscopy
Method of measurement
Numerical scale Level of cooperation (1 co lowest, 10 the highest Level of cooperation)

5

Description
Pain
Timepoint
After the bronchoscopy
Method of measurement
numeric pain scale (1 least amount of pain, 10 maximum pain)

Intervention groups

1

Description
Intervention group = received 30 minutes of nursing counseling program that includes training preparations in the days before bronchoscopy -training what done bronchoscopy- Basic skills training techniques to reduce anxiety
Category
Behavior

2

Description
Control group = received routine part of program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Najm Zadeh Zahra
Street address
Tehran - Bagher Khan Street - Imam Khomeini Hospital Complex
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Kyasalary Zahra - Deputy Director of Research and Technology
Street address
Tehran - Gulf Freeway - Opposite the shrine of Imam Khomeini
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahmoud Amiri
Position
Undergraduate Nursing students
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before the of Taleghani Crossroad- Alley Rhymzadh - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8587
Fax
+98 21 6641 8580
Email
mahmood.amiri18@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
PhD Nursing
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before Taleghani Crossroad- Rahimzadeh Alley - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8587
Fax
+98 21 6641 8580
Email
nrejeh@yahoo.com
Web page address
www.shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahmoud Amiri
Position
Undergraduate Nursing students
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before Taleghani Crossroad- Rahimzadeh Alley - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8587
Fax
+98 21 6641 8580
Email
mahmood.amiri18@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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