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The effect of psychological preparation on the anxiety level before colonoscopy in outpatients referred to Golestan hospital of Ahvaz

Protocol summary

Study aim
The aim of this study was to evaluate the efficacy of psychological effect on the anxiety level of preparation before colonoscopy in patients presenting to Golestan Hospital
Design
This study is a double-blind clinical trial consisted of 80 colonoscopy candidate patients that randomly divided into two groups( 40 patients in each group) ; Intervention and control
Settings and conduct
The study will be carried on patients presenting to Golestan Hospital in the colonoscopy unit. Patients and nurses will be not informed that every patient has taken which consultation
Participants/Inclusion and exclusion criteria
Patients aged 18-80 years, Farsi language conversation skills, ability to communicate verbally, the lack of previous experience in colonoscopy, having were included. While, patients with the risk of dementia, mental retardation, obvious physical problems that interfere in the consultation, a history of major psychiatric disorders and decline to participate were excluded from the study
Intervention groups
In this study, firstly, the clinical, demographic, questionnaire was completed based on information obtained from the patient as well as the contents of the file, including age, education, marital status, occupation, income level, gender, smoking history and family history of colonoscopy, the presence of other commodities, including high blood pressure, high blood lipids, diabetes, chronic renal failure and pulmonary disease. Then, to measure the amount of the patient's anxiety, Spielberger State-Trait Anxiety Inventory (STAI) was used. STAI includes separate self-assessment scales to measure the state and trait anxiety
Main outcome variables
Patient's anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170308032961N2
Registration date: 2018-04-22, 1397/02/02
Registration timing: retrospective

Last update: 2018-04-22, 1397/02/02
Update count: 0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Hadis Mehregan nasab
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8317
Email address
mehregan.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
2016-04-03, 1395/01/15
Actual recruitment end date
2017-04-04, 1396/01/15
Trial completion date
empty
Scientific title
The effect of psychological preparation on the anxiety level before colonoscopy in outpatients referred to Golestan hospital of Ahvaz
Public title
Effect of psychological preparation on the anxiety level before colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-80 years old Farsi language conversation skills Ability to communicate verbally Lack of previous experience in colonoscopy
Exclusion criteria:
Dementia Mental retardation Obvious physical problems that interfere with the consultation A history of major psychiatric disorders Decline to participation
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was based on the method of 4-way permuted blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurses were not informed that every patient has taken which consultation
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan BLV
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.REC.1394.415

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Anxiety
Timepoint
3-5 days before colonoscopy, After psychological preparation
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Psychological preparation was performed by a psychiatric resident in a separate room 2 to 3 hours before colonoscopy; after evaluating the concerns, the amount of information and the beliefs of the patients of colonoscopy in three domains: information, cognitive and behavioral the interventions were done as follows: Control Information: At this stage the patient inaccurate information is corrected and enough .1 explanation of additional information about how to perform a colonoscopy, time, duration and .general conditions of the process was given to the patient 2. Cognitive control: According to cognitive distortions found in patients, cognitive control was done for the patient (e.g., patient attention to the benefits of surgery and its positive tips instead focus on its unpleasant and negative aspects). 3. Behavioral control: the patient was given the behavioral control methods, including special breathing exercises, distraction techniques and an explanation on how the patient's knowledge-based colonoscopy to use these methods in the event of the occurrence of anxiety while doing a colonoscopy.
Category
Behavior

2

Description
Control group: In the control group, 0 to 3 hours before the colonoscopy, the intervention will be done and more neutral content (properties of fruits and vegetables) that was prepared in the pamphlet, will be given to control groups, and no other intervention will be done
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Hadis Mehregan
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 3632 2445
Email
ali.khossravi70@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mohammad Badvi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 3632 2413
Email
Ali.khossravi70@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
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
Ahvaz University of Medical Sciences
Full name of responsible person
Hadis Mehregan Nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 3631 2445
Email
ali.khossravi70@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadis Mehregan Nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 3631 2445
Email
ali.khossravi70@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadis Mehregan Nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 3631 2445
Email
ali.khossravi70@yahoo.com

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
There is no further information
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
Not applicable
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
Primary outcome measure will be available
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
For meta-analysis study
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Requested that by email and one week later, the data will be sent
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