The objective of this study is to determine the Effect of educational intervention on anxiety of patients undergoing colonoscopy. In this quasi- experimental study in colonoscopy Unit Of Shiraz University, 120 patients are scheduled to undergo colonoscopy. The patients are randomly allocated to experimental or control group. The patients in the experimental group receive intervention of nursing consultation lasted 30 minutes about colonoscopy before day, while control group does not receive any intervention. Anxiety level (recorded by spiel burg questioner) and vital signs are measured in both groups before intervention and on the colonoscopy day (immediately before the procedure). During the colonoscopy their satisfaction are measured by VAS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410268505N10
Registration date:2015-02-11, 1393/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-07, 1393/06/16
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational intervention on anxiety of patients undergoing colonoscopy
Public title
Effect of educational intervention on anxiety of patients undergoing colonoscopy, referred to endoscopy clinical of Shiraz hospital medical sciences 1393
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having order of colonoscopy at least one day before the procedure; Age between 18 and 80 years old; Ability to speak and understanding Persian language; no problem to see the VAS; no previous colonoscopy; no order of emergency colonoscopy; no History of psychological disease or anxiety disorder; no consumption of opiate or sedative drugs; no severe pain due to nature of disease; no addiction to opium or narcotics; no hypertension or using anti hypertensive drugs Exclusion criteria: canceling the colonoscopy due to any reason except for patient’s anxiety; no willingness to participate in the
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
shiraz
Postal code
71345-1978
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
93-203316
Health conditions studied
1
Description of health condition studied
colonoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
One day before Endoscopy(before consultation) and immediately before Endoscopy
Method of measurement
Spiel berg questioner
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
WHILE colonoscopy
Method of measurement
Visual Analog scale
2
Description
Blood pressure
Timepoint
One day before colonoscopy (before educational) and immediately before colonoscopy
Method of measurement
indicator
3
Description
Pulse
Timepoint
One day before colonoscopy (before educational) and immediately before colonoscopy
Method of measurement
By researcher
4
Description
Respiratory rate
Timepoint
One day before colonoscopy (before consultation) and immediately before colonoscopy
Method of measurement
By researcher
Intervention groups
1
Description
Intervention group: educational for half an hour one day before colonoscopy. This educational is including instruction about needing preparation pre colonoscopy (such as diet, drugs,...), explanation about stages pre(instruction necessary preparations), in(explanation about What will happen during colonoscopy)) and after(explanation about the probable problems that will meet after colonoscopy ) colonoscopy. It increase patient knowledge about colonoscopy and its advantages and probable risks and allow to patient that express his sensations and questions and answering the questions of patient.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
colonoscopy Unit Of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Street address
Hazrat-e-Fatimah nursing and midwifery college, Namazi hospital, Namazi square
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
seyed Baser Hashemy
Street address
Square Namazi, Shiraz University Medicine Sciences.
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Shiraz 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
Fatimah(PBUH) School of Nursing and Midwifery, Shiraz University of Medical ScienceNamazi Square
Full name of responsible person
Rasol Mohamadbigie
Position
Master of science
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science Namazi Square
City
Shiraz
Postal code
Phone
+7 138315561
Fax
Email
mohamadbigie@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Seyed Saeed Najafi
Position
MS in nursing - Faculty
Other areas of specialty/work
Street address
Fatimah(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science Namazi Square
City
Shiraz
Postal code
71345-1978
Phone
+91 61613828
Fax
Email
s_najafi44@yahoo.com najafisa@sums.ac.irr
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Seyed Saeed Najafi
Position
MS in nursing - Faculty
Other areas of specialty/work
Street address
Shiraz University of Medical Science
City
Shiraz
Postal code
Phone
+7 136474254
Fax
Email
s_najafi44@yahoo.com; najafisa@sums.ac.irr
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)