Our aim in this study is to compare the effects of Music and Midazolam on the anxiety levels during fibroptic bronchoscopy. In a randomized, single blinded uni-central study without Placebo, 60 male and female in or out-patients in Emam Reza hospital, Tabriz, with minimum age of 15 years would be involved during a 6 months period. Inclusion criterion is having indication for fibroptic bronchoscopy. Exclusion criteria are: patients with mental, hearing or speaking disorders; emergency bronchoscopy; patients with attention disorders; patients with brain defects; patients whom their mother tongue is not persian or azary; patients younger than 15 years old; patients under treatment with corticosteroids in systemic or inhale forms. Subjects would be randomly assigned in Midazolam or Music groups. Individuals in the first group will receive Midazolam 2mg intravenously 5 minutes before the initiation of the bronchoscpy and for subjects in the second group Music will be played using a headphone from 10 minutes before the bronchoscopy till the end of the bronchoscopy. Blood Nor-epinephrine, Epinephrine Cortisol levels, anxiety levels, blood oxygen saturation level and heart rate will be checked and recorded before (basal level) and after the bronchoscopy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012035287N2
Registration date:2012-01-10, 1390/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-10, 1390/10/20
Registrant information
Name
Akbar Sharifi
Name of organization / entity
Tabriz Medical University
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 5449
Email address
asharifi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-09-11, 1390/06/20
Expected recruitment end date
2012-03-09, 1390/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of Music and Midazolam on the anxiety levels during fibroptic bronchoscopy
Public title
Music or Midazolam ?! A new relaxation method during bronchoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: having indication for fibroptic bronchoscopy.
Exclusion criteria: patients with mental, hearing or speaking disorders; emergency bronchoscopy; patients with attention disorders; patients with brain defects; patients whom their mother tongue is not persian or azary; patients younger than 15 years old; patients under treatment with corticosteroids in systemic or inhale forms and patients with adrenal insufficiency.
Age
From 15 years old to 149 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Tabriz Medical University
Street address
Vice chancellor for research,Tabriz Medical University, Daneshgah square
City
Tabriz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
8961
Health conditions studied
1
Description of health condition studied
Bronchoscopy induced anxiety
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Heart rate
Timepoint
Before and after bronchoscopy
Method of measurement
Using continuous cardiac monitoring
2
Description
Anxiety level
Timepoint
Before and after bronchoscopy
Method of measurement
Using Beck's anxiety questionnaire
3
Description
Blood Oxygen saturation
Timepoint
Before and after bronchoscopy
Method of measurement
Using pulsoximetry
4
Description
Blood Cortisol level
Timepoint
Before and after bronchoscopy
Method of measurement
Using blood sampling and laboratory testing
5
Description
Blood nor-epinephrine level
Timepoint
Before and after bronchoscopy
Method of measurement
Using blood sapmling and laboratory testing
6
Description
Blood epinephrine level
Timepoint
Before and after bronchoscopy
Method of measurement
Using blood sampling and laboratory testing
Secondary outcomes
empty
Intervention groups
1
Description
Injection of 2mg midazolam IV 5 minutes before bronchoscopy for group Midazolam
Category
Treatment - Drugs
2
Description
Playing music by a headphone 10 minutes before the initiation of bronchoscopy for group Music
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Akbar Sharifi
Street address
Emam Reza hospital, Golgast street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz Medical University, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical 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
Tabriz Medical University
Full name of responsible person
Akbar Sharifi
Position
Subspecialist in pulmonary diseases, Assistant professor
Other areas of specialty/work
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1336 4901
Fax
Email
ak.sharif@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Akbar Sharifi
Position
Subspecialist in pulmonary diseases, assistant professor
Other areas of specialty/work
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1336 4901
Fax
Email
ak.sharif@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Akbar Sharifi
Position
Subspecialist in pulmonary diseases, assistant professor
Other areas of specialty/work
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)