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The effect of psychological preparation on the level anxiety before upper gastrointestinal endoscopy

Protocol summary

Summary
In a randomized clinical trial 96 patients who were referred to gastroenterology clinic of Ahvaz Golestan Hospital were selected. According to random number table, patients were divided into two groups of control and intervention, that each group has 48 members. After the study was explained to the patients, they were asked to fill out the consent form. After the inclusion and exclusion criteria were taken into account, the patients were randomly divided into an experimental and a control group, each of which included 48 patients. Inclusion criteria such as age of 18-80 years, participants should able to communicate, and can speak Farsi, lack of conduction of EGD before and Exclusion criteria like having cognitive problem, and if they had history of major psychological disorder and cognitive problem, they were excluded. This study is open-label and categorize in 2-3 trial phase. Aim of this study is to determine state and trait anxiety and compare them in intervention and control group. A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients referred to the gastroenterology clinic for endoscopy that represents the basic anxiety and the second time one hour before endoscopy (after intervention). For the experimental group, after the questionnaire was completed in the first phase, psychological preparation was carried out for the patients 2-3 hours before endoscopy. After their anxiety, information, and beliefs about endoscopy conduction were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control (special breath exercises, swallowing training, and distraction technique). The same time, pamphlets (properties of fruits and vegetables) gave to control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091020739N2
Registration date: 2016-05-17, 1395/02/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-17, 1395/02/28
Registrant information
Name
Forouzan Behroozina
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
behrouzian-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychological preparation on the level anxiety before upper gastrointestinal endoscopy
Public title
Comparison between the effects of psychological preparation and no preparation on anxiety level in patients who are candidate for upper gastrointestinal intervention
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 80-18 years؛ the language Farsi؛ the ability to communicate verbally؛ with no history of previous upper endoscopy؛ a consent to enter the scheme. Exclusion criteria: the risk of dementia؛ mental retardation؛ distinctive physical problems that interfere consultation in the history of major psychiatric disorders؛ that the patients is not cooperative.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization was done by random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Farvardin Blvd, Golestan Ave, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.129

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F40,F41,F4
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
State Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberg questioner

2

Description
Trait Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberge questioner

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients referred to the gastroenterology clinic for endoscopy that represents the basic anxiety and the second time one hour before endoscopy (after intervention). For the experimental group, after the questionnaire was completed in the first phase, psychological preparation was carried out for the patients 2-3 hours before endoscopy. After their anxiety, information, and beliefs about endoscopy conduction were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control (special breath exercises, swallowing training, and distraction technique
Category
Behavior

2

Description
For control group some general information about fruits and vegetable in pamphlets form have been placed at their disposal to study, another intervention do not be.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
َAhvaz Golestan Hospital
Full name of responsible person
Forouzan Behrouzian
Street address
Ahvaz Golestan Blvd
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Frouzan Behrouzian
Street address
Ahvaz Golestan Hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Neda Sadri Zade Irani
Position
Resident
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
n.sadri.irani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
fbehrouzian2@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
fbehrouzian2@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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