Protocol summary

Study aim
Evaluation of the effectiveness of emotion regulation skills training on gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome
Design
Quasi-experimental intervention with pre-test and post-test with control group. With a sample size of 48 people.The permuted random blocking method is used to do randomization
Settings and conduct
The statistical population is outpatients with irritable bowel syndrome.With the referral of Dr. Elham Mokhtari, an internal medicine specialist and gastroenterologist, they enter the study with the inclusion criteria.They are randomly divided into control and intervention groups.The experimental group is trained in emotion regulation skills.These skills are held according to the Gross protocol and in 8 sessions in Mashhad University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Irritable bowel syndrome with diagnosis of gastroenterologist and diagnostic criterion Romm-III Age 20 to 55 years Have at least 8 literacy classes Having informed consent to enter the research Have at least some insight into the psychological cause of your illness
Intervention groups
Emotion adjustment skills training for the experimental group. The control group did not intervene.
Main outcome variables
Digestive sensitivity, disease perception, anxiety sensitivity, quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210515051300N1
Registration date: 2021-07-20, 1400/04/29
Registration timing: registered_while_recruiting

Last update: 2021-07-20, 1400/04/29
Update count: 0
Registration date
2021-07-20, 1400/04/29
Registrant information
Name
Samane Soltanabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3734 4825
Email address
soltanabadis981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-19, 1400/04/28
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion regulation skills training on gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome
Public title
The effectiveness of emotion regulation skills training on gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Irritable bowel syndrome with diagnosis of gastroenterologist and diagnostic criterion Romm-III Age 20 to 55 years Have at least 8 literacy classes Having informed consent to enter the research Have at least some insight into the psychological cause of your illness
Exclusion criteria:
Severe physical condition (such as bleeding and severe pain) Acute psychiatric illness that makes it difficult to participate in treatment (such as psychotic disorders, bipolar disorder, major depression, suicide attempt) Absence for more than two sessions.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The permuted random blocking method is used to do randomization. In this method, 12 blocks of 4 will be randomly selected from a combination of letters A and B. These blocks are as follows AABB, ABBA, BBAA, BAAB, ABAB, and BABA. Allocating the letters A and B to the intervention and control groups will be done randomly before randomization and the data analyst will be unaware of the intervention and control groups. The researcher, having a list of people (a list of 48 people who are going to participate in the project), assigns a numeric code to each person. It then offers the anonymous list of members (containing only the numeric code) to the sample assignor to the groups. First, the sample assignor organizes the selected blocks as described, writes them on separate sheets of paper (12 separate sheets), and places them in sealed envelopes. Then s/he randomly selects the envelopes and, based on the previously selected codes, A and B, determines the numerical code number of the individuals assigned to A and B interventions and provides it to the researcher. For instance, if the BABA block is selected first, the first person on the list will be assigned to group B, the second person to group A, the third person to group B, and the fourth person to group A. Likewise, participants 5 to 48 will be assigned to groups A and B.
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 Mashhad University of Medical Sciences
Street address
Khaghani 19, No. 192
City
Mashhad
Province
Razavi Khorasan
Postal code
66373_91949
Approval date
2021-04-13, 1400/01/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.125

Health conditions studied

1

Description of health condition studied
Gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome
ICD-10 code
K58.9, k58
ICD-10 code description
Irritable bowel syndrome with diarrhoea, Irritable bowelsyndrome without diarrhoea

Primary outcomes

1

Description
Gastrointestinal allergies
Timepoint
Beginning and end of the study
Method of measurement
Labas Digestive Sensitivity Questionnaire et al.

2

Description
Perception of disease
Timepoint
Beginning and end of the study
Method of measurement
Disease Perception Broadbent et al

3

Description
Anxiety sensitivity
Timepoint
Beginning and end of the study
Method of measurement
Taylor and Cox Anxiety Sensitivity Questionnaire

4

Description
Quality of Life
Timepoint
Beginning and end of the study
Method of measurement
Patrick and Dorsman Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
8 sessions of emotion regulation skills training are held twice a week for 90 minutesThese meetings are based on the Gross protocol.The content of the sessions includes familiarity with the concept of emotion and types of emotions,Talk about emotion performance and its benefits, introduce the Gross emotion regulation model and learning how to regulate emotion based on this protocol.
Category
Other

2

Description
Control group: They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of a gastroenterologist
Full name of responsible person
Elham Mokhtari
Street address
خاقانی 19
City
mashhad
Province
Razavi Khorasan
Postal code
66373_91949
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Taqfadi
Street address
Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
66373_ 91949
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
66373_91949
Phone
+98 51 3734 4825
Email
samanesoltanabadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
66373_91949
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document
.
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