The effect of the education on fear and anxiety in patients undergoing colonoscopy in hospitals of Kerman city, 2017
Design
Clinical trial with control group, patients in intervention group on pairs and control group on days.The sample size is 90 patients.
Settings and conduct
Patients in the intervention group will be instructed, but the control group will have routine care.
In order to conduct research, a researcher will be presenting a colonoscopy candidate in the department of gastrointestinal and internal wards of Kerman hospitals before the colonoscopy on the day before and after expressing the research goals and having the conditions for entering the study and written consent for participation in the research. Will do research.Demographic information questionnaire, Spielberger anxiety inventory and colonoscopy fear questionnaire will be filled in by the researcher by interview method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a Permission to perform colonoscopy for a colonoscopy, aged 18 to 80 years of Iranian nationality. Exit criteria:The use of sleep medications quiet section,Having aches,Drug addiction or strong analgesics,Use of sedative medications and colonoscopy history.
Intervention groups
Patients undergoing colonoscopy have paused days in the intervention group and in the control group days.The intervention group is being trained, but the control group will have routine care.
Main outcome variables
The amount of anxiety; fear In patients with colonoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160914029817N5
Registration date:2018-06-02, 1397/03/12
Registration timing:registered_while_recruiting
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training on fear and anxiety of patients undergoing colonoscopy
Public title
The effect of training on fear and anxiety of patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having an order for colonoscopy
aged 18 to 80 years old, and Iranian specialty
Exclusion criteria:
Use of sleepy and sedative medicines
having pain
addiction or strong analgesics
using sedative medications
colonoscopy history
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random allocation method to control and intermediate group,Random unit of the sample that the intervention group is placed on a couple of days and a control group on an individual's day.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There are 45 patients in the intervention group on pair days and 45 patients in the control group on days
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of kerman university of Medical Sciences
Street address
Kerman, the beginning of the Compus University of Medical Sciences, beginning around Seven Gardens Alavi, kerman Boulevard Haft Bagh Alavi, Medical Sciences Campus Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-04-03, 1397/01/14
Ethics committee reference number
ir.kmu.rec.1396.2467
Health conditions studied
1
Description of health condition studied
Patients with colonoscopy candidates
ICD-10 code
K55-k64
ICD-10 code description
Other diseases of intestines
Primary outcomes
1
Description
Anxiety Score in Spielberg's Questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Spilberger State-Trait Anxiety Inventory
Secondary outcomes
1
Description
Measure the amount of fear
Timepoint
Before intervention and after intervention
Method of measurement
Colonoscopy Fear Questionnaire
Intervention groups
1
Description
Intervention group: Patients with colonoscopy candidates are trained in the intervention group on pair days.The purpose of educational intervention is to provide information on colonoscopy, the importance and benefits of using it, an explanation of all stages before, during and after colonoscopy, pre-colonoscopy training, an appropriate position during the test, an opportunity to express feelings And questions, answers to possible questions, and deep breathing training for patients.
Category
Behavior
2
Description
The control group, only routine actions are performed on individual days.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Nadere Baniasadi
Street address
Kerman, Imam Khomeini highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
+98 34 3325 7770
Email
afzalih@kmu.ac.ir
Web page address
http://kmu.ac.ir
2
Recruitment center
Name of recruitment center
Great Prophet hospital
Full name of responsible person
Nadere Baniasadi
Street address
Kerman,Abu hamed street
City
Kerman
Province
Kerman
Postal code
7614749549
Phone
+98 34 3226 6595
Fax
+98 34 3325 7770
Email
nadere.baniasadi@gmail.com
Web page address
http://tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhty
Street address
Compus University of Medical Sciences rdens Alavi, Research Management,St.Ibn Sina,Tahmasebabad Crossroads.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
http://vcrt.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Nadere Baniasadi
Position
Master of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences, beginning around Seven Gardens Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
nadere.baniasadi@gmail.com
Web page address
http://kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Esmat.Nuhi
Position
Associate professorََ
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences beginning around Seven Gardens Alavi;Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
+98 34 3132 5218
Email
e_nuhi@kmu.ac.ir
Web page address
htpp://kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nadere Baniasadi
Position
Master of Medical Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences, beginning around Seven Gardens Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3246 3507
Fax
+98 34 3132 5219
Email
nadere.baniasadi@gmail.com
Web page address
http://kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD