The aim of this research was to determine the effect of hypnotherapy on the severity of gastrointestinal symptoms, anxiety score and quality of life in patients with irritable bowel syndrome.The inclusion criteria were having at least three months history of suffering from irritable bowel syndrome siseaseand exclusion criteria were also suffering from other gastrointestinal disease or recognized psychical disease.In the clinical trial study,100 patients referred to the Shahid Faghihi and Motahari clinics divided randomly into groups of control and experimental. Hypnotism was done by scientific method for 3 sessions of 1 hour each during 15 weeks for patients of experimental group. Before and after each time hypnotism, the questionnaire of determining the severity of gastrointestinal symptoms , anxiety scores and quality of life of patients with IBS was completed. Of course , self-hypnosis was also done by patients in between sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102264775N2
Registration date:2015-06-15, 1394/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Zinat Mohebbi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zmohebi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology ,Shiraz University of Medical Sciences
Expected recruitment start date
2010-12-30, 1389/10/09
Expected recruitment end date
2011-12-30, 1390/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypnotherapy on gastrointestinal symptoms severity,anxiety scores and quality of life in patients with irritable bowel syndrome.
Public title
The effect of hypnotherapy on irritable bowel syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having ages between 20 to 60 years; possessing the literacy of at least primary fifth class; IBS diagnosis by gastroenterologist; having at least three months history of suffering from IBS disease and being under the IBS usual therapeutic program; showing propensity of participating in hypnotherapy sessions and filling the written letter of satisfaction. Exclusion criteria: suffering from other gastrointestinal diseases or recognized psychical disease; being under other therapeutic programs like homeopathy, relaxation etc.; having the symptoms of reflux and functional dyspepsia; cancer history in individual or family; having anemia and positive stool test for parasite or blood
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research and technology, Shiraz University of Medical Sciences
Street address
Central Building Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
صندوق پستي:713451978
Approval date
2010-12-29, 1389/10/08
Ethics committee reference number
89,241877
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrom
ICD-10 code
K58.0
ICD-10 code description
irritable bowel syndrome
Primary outcomes
1
Description
Gastrointestinal symptoms included abdominal pain, feeling cramp above abdomen, nausea and vomiting, borborygmus, abdominal distension, constipation, diarrhea, loose stool, solid stool, feeling urgent defecation and feeling tenesmus.
Timepoint
3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week.
Method of measurement
Gastrointestinal Symptom Rating Scale
2
Description
Quality of Life
Timepoint
3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week.
Method of measurement
IBS specific quality of life
3
Description
Anxiety
Timepoint
3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week.
Method of measurement
Spielberger State Trait Anxiety Inventory(SSTAI)
Secondary outcomes
empty
Intervention groups
1
Description
After obtaining the written letter of satisfaction to take part in the research and completing demographic questionnaire by physician, the usual treatment (drug-therapy) was started for patients and then was introduced to researchers. Thereafter, these patients were divided into two control and intervention groups as Block randomization. At the next stage, three weeks from beginning of treatment and introducing patient to researcher, the Hypnotism of patient was carried out in sessions of one hour and in the presence of third person (except Hypnotizer and patient) for the intervention group. The first Hypnotherapy was carried out in the beginning of forth week of research and again it was done in the beginning of sixth week by scientific method. In these sessions, creating fatigue in eyes and muscular relaxation, creating concentration and Hypnotism, going deep into Hypnotism via reinforcement of imaginations and mental incarnation, giving positive and effective inculcations were educated. Lightening the Hypnotism and sending patient out of it was finally taken place.
Category
Other
2
Description
Hypnotherapy did not carry out for control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic of Shiraz
Full name of responsible person
Zinat Mohebbi
Street address
Shahid Motahari Clinic, Namazi Squer
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Scienecs Shiraz
Full name of responsible person
Mr skandari
Street address
Central Building Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
بودجه رديف طرحهاي پژوهشي
Grant code / Reference number
89-5340
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Scienecs Shiraz
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
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
PhD Student,Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery College, Namazi Squer
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Phd Candidate, Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery College, Namazi squer
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Phd Candidate, Faculty Member
Other areas of specialty/work
Street address
Nursing and Midwifery College, Namazi Squer
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)