The study of consulting nurse role in pre operative assessment clinic on reducing the anxiety of patients candidate for surgical operation referred to pre_anesthesia assessment clinic in Imam Reza hospital: A randomized controlled trial
The objective of this study is to determine the efficacy of consulting nurse in pre-operative assessment clinic, in reducing the anxiety of patients who are candidate for surgical operation. The total sample size is 414 patients (207 will be randomly assigned to experimental group and 207 to the control group). Patients in the experimental group will be consulted by a nurse and the control group received usual preoperational visits. The main outcome measure is Hamilton Anxiety Scale measured before consultation and after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803291310N2
Registration date:2009-09-09, 1388/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-09, 1388/06/18
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-06-05, 1388/03/15
Expected recruitment end date
2010-06-05, 1389/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of consulting nurse role in pre operative assessment clinic on reducing the anxiety of patients candidate for surgical operation referred to pre_anesthesia assessment clinic in Imam Reza hospital: A randomized controlled trial
Public title
The study of consulting nurse role in pre operative assessment clinic on reducing the anxiety of patients candidate for surgical operation referred to pre_anesthesia assessment clinic in Imam Reza hospital: A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Signing informed consent, age more than 18 years, ability to speech
Exclusion criteria: presence of significant mental or cognitive disorders
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
414
Randomization (investigator's opinion)
Randomized
Randomization description
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
Kermanshah University of Medical Sciences
Street address
Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2009-06-02, 1388/03/12
Ethics committee reference number
88009
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Hamilton Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will be consulted by educated nurse on pre-operation and post-operation conditions and patient’s questions will be answered.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Naser Yeganeh
Street address
Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Najafi
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Naser Yeganeh, MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza Hospital, Kermanshah University of Medical Sciences