The aim of the study is to determine the comparison of laughter yoga and anti anxiety medication on anxiety and gastrointestinal symptoms of patients with irritable bowel syndrome
Design
In this research, 60 eligible patients with irritable bowel syndrome referring to gastrointestinal clinic were chosen purposefully and were randomly divided into three groups of interventions with laughter yoga, anti anxiety medication and symptomatic treatmentby closed packets.
Settings and conduct
This study which will be conducted in gastrointestinal clinic of valiasr hospital birjand. patients will be divided into three groups randomly with 20 members and in the end of interventions, efficacy will be evaluated with IBS severity scoring system and beck anxiety inventory.
Participants/Inclusion and exclusion criteria
Patients aged between 18 and 50 years old؛ patients who accepted to participate in the study after explaining the purposes of the study and advantages and disadvantages of the interventions؛ Patients who do not have any other anatomical or functional gastrointestinal disorders.
Intervention groups
60 eligible patients with irritable bowel syndrome were randomly divided into three groups of interventions with laughter yoga, anti anxiety medication and symptomatic treatment by closed packets.
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Laughter Yoga and anti-anxiety medication on anxiety and gastrointestinal symptoms of patients with irritable bowel syndrome
Public title
Efficacy of Laughter Yoga and anti-anxiety drugs on irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 and 50 years old
Patients who accepted to participate in the study after explaining the purposes of the study and advantages and disadvantages of the interventions
There should be the possibility to keep the type and dose of the medications fixed during the study
Patients who do not have psychotic or personality disorders
Patients who do not have alarm signs including gastrointestinal bleeding, blood in stool, fever, weight loss, anemia, diarrhea at night, severe abdominal pain and so on
Exclusion criteria:
Patients who receive psychological treatments before entering the study
Patients who have any other anatomical or functional gastrointestinal disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomizashin by sealed envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Faculty of medicine, Birjand University of Medical Sciences, Ghaffari street, Birjand
City
Birjand
Province
South Khorasan
Postal code
9187874151
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
Ir.bums.REC.1396.82
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
K58.9, K58
ICD-10 code description
Irritable bowel syndrome without diarrhoea ,Irritable bowel syndrome with diarrhoea
Primary outcomes
1
Description
Irritable Bowel Syndrome severity
Timepoint
Before and right after the end of intervention
Method of measurement
Irritable Bowel Syndrome severity score system designed by Francis CY in 1997: mild (8 to 18) - moderate (18 to 30) - severe ( more than 30)
Secondary outcomes
1
Description
Anxiety severity
Timepoint
Before and right after the end of intervention
Method of measurement
Anxiety score from beck anxiety inventory
Intervention groups
1
Description
Intervention in the first intervention group:Laughter Yoga:Laughter Yoga combines unconditional laugh with yoga breathing and yoga stretching exercises, and people laughing without any jokes. Meetings will be held once a week. there are seven Meetings of stress management therapy by Laughter Yoga, each meetings duration are one hour, a first meeting is justification of Laughter Yoga for participants, and the next five meetings are training and practice of laughing techniques, and the last meeting is practice and repetition of training of the previous one will be. Severity scorring system of irritable bowel syndrome designed by Francis CY in 1997. Mild (score 8 to 18), moderate (score 18 to 30) and severe (above 30)
Category
Behavior
2
Description
Intervention in the second intervention group:
Anti-anxiety treatment:
Sertraline, 50 mg orally once a day for seven weeks
Category
Treatment - Drugs
3
Description
Control group:
Symptomatic treatment with loperamide and hyoscine
Loperamide: 2 mg orally three to four times a day for seven weeks
Hyoscine: 20 mg orally four times a day for seven weeks