Protocol summary

Summary
Participants were randomly divided into intervention (30 patients) and control (30 patients) groups. At first, obtaining written informed consent from participants is a signature on a form. After that, through interview and review of patient record, personal demographics, individual health status and diseases was completed. Before the procedure, level of blood pressure (systolic and diastolic) and Pulse rate (per minute), through “mobile vital signs monitor”, was recorded for all subjects by the second investigator who was unaware of the intervention and control groups. Also, the visual analog scale (VAS) and the anxiety questionnaire (The Spielberger State-Trait Anxiety Inventory (STAI)) through interview and patient self-report were filled. Patient, at the Bronchoscopy room, was on the bed with supine position so that the bed under the patient's head was 30 degrees angle. In the intervention group, at the same time, the patient was put on headphones to listen to music and nature images on the screen via video projector, ten minutes before the start to the end of Bronchoscopy, was broadcast. During Bronchoscopy for both groups, blood pressure and pulse rate were recorded every three minutes (after the third, sixth and ninth). After the end of Bronchoscopy, The third part of the questionnaire was completed by the researcher for all participants in the test. Finally, after the patient calm and before leave the Bronchoscopy room, patient tolerance was recorded by visual analog scale (VAS) for tolerance indices during bronchoscopy. The anxiety questionnaire that was delivered to the patient by a second researcher was filled with interviews and self-reports by patients. Also blood pressure and pulse rate were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042922001N1
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Shahla Soleymani
Name of organization / entity
Zahedan Univercity Of Medical Science, School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
soleymanish2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research & Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Distraction on Anxiety and Tolerance in patient undergoing Bronchoscopy admitted to Emam Ali Hospital in Zahedan , 2015
Public title
The effect of Distraction on Anxiety and Tolerance in patient undergoing Bronchoscopy admitted to Emam Ali Hospital in Zahedan , 2015
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: participants should: be between 20 to 60 years old; have the ability of speaking and Persian language understanding; be conscious and health on their hearings and visions; be undergoing bronchoscopy for the first time. Exclusion criteria: have background of severe psychological problems; have a severe symptoms (pain, cough and dyspnea) caused by respiratory diseases (asthma, lung cancer, etc); use the strong sedative or narcotic before bronchoscopy; be under treatment with corticosteroids (systemic or inhalation); have the emergency indication bronchoscopy.
Age
From 20 years old to 60 years old
Gender
Both
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
Zahedan University of Medical Sciences
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.ZAUMS.REC.1394.85

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
43.0F
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Anxiety
Timepoint
Before the start Bronchoscopy, ten minute after finishing Bronchoscopy.
Method of measurement
The Spielberger State-Trait Anxiety Inventory (STAI)

2

Description
Tolerance
Timepoint
Before the start Bronchoscopy, ten minute after finishing Bronchoscopy.
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Systolic and Diastolic Blood Pressure
Timepoint
Before start Bronchoscopy, every three minutes (after the third, sixth and ninth) during bronchoscopy, ten minutes after finishing bronchoscopy.
Method of measurement
Mobile Vital Signs Monitoring Device

2

Description
Pulse Rate
Timepoint
Before start bronchoscopy, every three minutes (after the third, sixth and ninth) during bronchoscopy, ten minutes after finishing bronchoscopy.
Method of measurement
Mobile Vital Signs Monitoring Device

Intervention groups

1

Description
In the intervention group, at the same time, the patient was put on headphones to listen to music and nature images on the screen via video projector, ten minutes before the start to the end of Bronchoscopy, was broadcast.
Category
Other

2

Description
The control group received usual care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Hospita
Full name of responsible person
Nezar Ali Muolai
Street address
Ali Ebne Abitaleb Hospital, khalije Fars Blvd
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Hoshang Rafighdost
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square,
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Science
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
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
Shahla Soleymani
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer Squar
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2482
Email
soleymanish2@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
Ali Navidian
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
alinavidian@gmail.com
Web page address
http://zfnm.zaums.ac.ir/index.aspx?fkeyid=&siteid=149&pageid=19909

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
Shahla Soleymani
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
soleymanish2@mums.ac.ir
Web page address
http://zfnm.zaums.ac.ir/index.aspx?fkeyid=&siteid=149&pageid=19909

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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