Determination of the effect of Nursing Counseling on the anxiety level of elderly patients undergoing endoscopy
Design
A randomized, controlled clinical trial with a parallel group design of 198 patients, enrolled between April 2020 and July 2020.
Settings and conduct
This study will be performed on 198 elderly patients who are candidates for the upper gastrointestinal endoscopy and refer to Imam Khomeini Hospital in Bandar Turkman and meet the inclusion criteria.
All the patients will receive routine care before endoscopy, but the patients in the intervention group will consult based on the educational package prepared for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 60 years old, Upper gastrointestinal endoscopy is prescribed at least one day in advance, No previous endoscopic history, Having the ability to establish verbal communication, Not taking corticosteroid drugs, Willingness to participate in the study.
Exclusion criteria: Using hypnotic and sedative drugs before endoscopy, addiction, Known case of psychiatric disease, Having any lesion or ulcer in the mouth.
Intervention groups
Intervention group: The patients in the intervention group will be received 30 minutes face to face educational counseling on the night before endoscopy. The educational counseling will be done based on the content of the booklet which produced by researchers and then the booklet is given to the patient.
Control group: The patients in the control group will receive the pre-endoscopic preparations and routine care
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041501N1
Registration date:2020-05-08, 1399/02/19
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
sohrab kor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3443 2486
Email address
nurse.kor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing counseling on the anxiety level of elderly patients undergoing upper gastrointestinal endoscopy
Public title
The effect of nursing counseling on the anxiety level of elderly before endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years old
Upper gastrointestinal endoscopy is prescribed at least one day in advance
No previous endoscopic history
Having the ability to establish verbal communication
Not taking corticosteroid drugs
Willingness to participate in the study
Exclusion criteria:
Using hypnotic or sedative drugs before endoscopy
Addiction
Known case of psychiatric disease
Having any lesion or ulcer in the mouth
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization:
Patients will be randomly and equally (n=99) allocated to two intervention and control groups by a nurse, working in the inpatient ward, who has been trained in the random allocation of patients. Random allocation will be done as follows; first, we will consider two AB and BA combinations designated with the code names 1 and 2, respectively by throwing a homogeneous hexagon. If the odd number occurs, we will write down combination 1 (AB) and If the even number occurs, we will write down combination 2 (BA). This step will be repeated 99 times to create a random sequence of twin blocks. Then we randomly assign the patients to the members of this sequence (A and B).
For example, the sequence of random blocks can be as follows:
BABAABABABBA…
Afterwards, by throwing a flawless coin, the patients assigned to the letter A will fall into the intervention group and the patients assigned to the letter B will fall into the control group.
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
Ethics Committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.GOUMS.REC.1397.200
Health conditions studied
1
Description of health condition studied
The anxiety of elderly patients undergoing upper gastrointestinal endoscopy
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Level of anxiety
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
Spielberger Anxiety Inventory
Secondary outcomes
1
Description
Level of salivary cortisol
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
Saliva cortisol measurement kits, made by Diametra in Italy using ELISA method
2
Description
Blood pressure
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
The Sazgan Gostar portable monitoring system, Vista Model, made in Iran..
3
Description
Heart rate
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
The Sazgan Gostar portable monitoring system, Vista Model, made in Iran.
4
Description
Respiratory rate
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
The Sazgan Gostar portable monitoring system, Vista Model, made in Iran.
5
Description
Arterial blood saturation percentage
Timepoint
Before intervention and a day after intervention (before endoscopy)
Method of measurement
The Sazgan Gostar portable monitoring system, Vista Model, made in Iran.
Intervention groups
1
Description
Intervention group: The patients in the intervention group will be received 30 minutes face to face educational counseling on the night before endoscopy. The educational counseling will be done based on the content of the booklet which produced by researchers and then the booklet is given to the patient.
Category
Other
2
Description
Control group: The patients in the control group will receive the pre-endoscopic preparations and routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ali Bidari
Street address
Imam Khomeini Hospital, Arekhi Boulevard, Bander Torkeman city, Golestan province
City
Bander Torkeman
Province
Golestan
Postal code
4891674811
Phone
+98 17 3442 3091
Fax
+98 17 3442 4442
Email
nurse.kor@gmail.com
Web page address
http://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sohrab Kor
Position
Ms student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Geriatric nursing
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3217 5338
Fax
+98 17 3245 5171
Email
Nurse.kor@gmail.com
Web page address
http://goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Shohreh Kolagari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
dr.kolagari@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sohrab Kor
Position
Ms student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Geriatric nursing
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
nurse.kor@gmail.com
Web page address
http://goums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after identifying people.
When the data will become available and for how long
Six months after publishing, the results of the data file will be presented.
To whom data/document is available
Data will be available to researchers working in academic institutions.
Under which criteria data/document could be used
Meta analysis on data are allowed.
From where data/document is obtainable
Please contact the person responsible for the study.
What processes are involved for a request to access data/document
Access to data through e-mail after obtaining permission from researchers is possible.
Comments
To receive information, please email both the following addresses:
kolagari_gorgan@yahoo.com; dr.kolagari@goums.ac.ir