The aim of the present study is to determine the impact of hypnotherapy alongside pharmacotherapy with pharmacotherapy alone on quality of life and symptoms of irritable bowel syndrome patients.This is a clinical trial study in which 34 patients will select using Rome-III criteria.Inclusion criteria will include of diagnostic irritable bowel syndrome base on Rome-III criteria and participate of volunteere in the project and exclusion criteria will include history of receiving psychotherapy during 6 mounts ago and irritable bowel syndrome with constipation and mix predominance. ptients will randomly divided into two groups of 17 patients.The first group underwent hypnotherapy alongside pharmacotherapy.The second group receive pharmacotherapy alone.The quality of life (QOL-IBS) and Bowel Symptom Severity and Frequency (BSS-FS)will assessment for both groups befor and after therapeutic intervention.Patients will follow-up for a peiod of 6 month after the intervention.
General information
Acronym
Efficacy of hypnotherapy with pharmacotherapy and pharmacotherapy on quality of life and symptoms
IRCT registration information
IRCT registration number:IRCT201210268253N2
Registration date:2012-12-09, 1391/09/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Sayed Kamal Solati
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38133338157
Email address
kamal_solati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2012-09-05, 1391/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of pharmacotherapy and hypnotherapy with pharmacotherapy on quality of life and symptoms of irritable bowel syndrome patients
Public title
The effecacy hypnotherapy on treatment of irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of diagnostic irritable bowel syndrome base on Rome-III criteria; Participate of volunteered in the project;The minimum level of literacy in primary.
Exclusion criteria:
The presence of organic damage and cognitive dysfunctions such as dementia and mental retardation;The presence of history of receiving psychotherapy during 6 mounts ago;Irritable bowel syndrome with constipation and mix predominance.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences,Kashani street,Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
91-3-1
2
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences,Kashani street,Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2012-08-20, 1391/05/30
Ethics committee reference number
1-3-91
Health conditions studied
1
Description of health condition studied
سندرم روده تحریک پذیر
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Quality of Life
Timepoint
before of intervention,after of intervention and after 6 intervention (follow-up)
Method of measurement
Quality of life test
2
Description
Bowel symptoms of severity and frequency
Timepoint
before of intervention,after of intervention and after 6 intervention (follow-up)
Method of measurement
Bowel symptoms of severity and frequency scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hypnotherapy with Pharmacotherapy. In this group,patients will underwent for 5 hypnotherapy session,in addition to current pharmacotherapy.
Category
Treatment - Other
2
Description
Control group: Pharmacotherapy. This group will underwent current pharmacotherapy alone.