The present study is based on the body of evidence which suggests awareness of internal emotions as important factors to relief from psychosomatic disorders which cannot be achieved without continuous attention toward internal emotions and challenge with their interpretation. The current study aims to actuate patients with irritable bowel syndrome to their emotions and decreasing somatization of the problem by effective expression of them. Sixty patients with irritable bowel syndrome will be enrolled from the clinic of Tabriz University of Medical Sciences. All patients will receive the proposed medical treatment by the gastroenterologist. A psychiatrist will explain the concept of arousal and the eight main emotions to the patients in the intervention group. These patients will analyze their arousal level and emotions once daily and record it in a chart. Both groups will be revisited one week and one month later by the gastroenterologist blinded to the intervention for assessment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810152999N1
Registration date:2010-05-15, 1389/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-15, 1389/02/25
Registrant information
Name
Alireza Farnam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5951
Email address
farnama@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Liver and gastrointestinal diseases research center, Tabriz univeristy of medical sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of emotional awareness on symptoms of patients with irritable bowel syndrome
Public title
Effect of emotional awareness on symptoms of patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Educational level of high school diploma or higher. Exclusion criteria: Major psychiatric disorder, Substance dependence, suicidal ideations, history of psychosis, Pregnancy, Using OCP medications
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabariz Univeristy of medical sciences
Street address
Univeristy Ave
City
Tabriz
Postal code
Approval date
2008-12-16, 1387/09/26
Ethics committee reference number
5/4/8073
Health conditions studied
1
Description of health condition studied
Irritbale bowel syndrome
ICD-10 code
K-58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Severity of pain
Timepoint
1 month
Method of measurement
Visual analouge scale
2
Description
Frequency of pain
Timepoint
one month
Method of measurement
interview
Secondary outcomes
1
Description
Quality of life
Timepoint
1 month
Method of measurement
questionnaire
Intervention groups
1
Description
The intervention group will be educated about the concept of the 8 basic emotions during a 0.5-hour session using examples and figures, as well as receiving the indicated medications. The participants will estimate the mixture of their emotions regarding their feelings and will sign them on the designated table during the study period every day on at given time. They may refere to solve any problem about the process as well.
Category
Other
2
Description
The control group will only receive indicated medications.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Univeristy Clinic, Tabriz univeristy of medical sciences
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Liver and gastrointestinal diseases research center
Full name of responsible person
Dr M H Somi
Street address
Imam Reza hospital, Golbad Ave;
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Liver and gastrointestinal diseases research center
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
Tabriz university of medical sciences
Full name of responsible person
Miss Mahdavi
Position
Master of psychology
Other areas of specialty/work
Street address
Razi hospital, Elgoli road
City
Tabriz
Postal code
Phone
+98 914 914 3304
Fax
Email
SFARHANG@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Univeristy of medical sciences
Full name of responsible person
Dr Sara Farhang
Position
M.D.
Other areas of specialty/work
Street address
Razi hospital, Elgoli road,
City
Tabriz
Postal code
Phone
+98 41 1336 7499
Fax
+98 41 1380 3351
Email
dsfarhang@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Sara Farhang
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)