The effectiveness of emotion regulation training on stress coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer
Determining the effectiveness of emotion regulation training on coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer
Design
Clinical trial with two groups of control and experimental
Settings and conduct
The present study will be a quasi-experimental type. The data of this study will be selected from patients aged 20 to 50 years with a diagnosis of peptic ulcer who have referred to Ayatollah Taleghani Hospital in Tehran and have endoscopic indications and have been approved by a gastroenterologist. Gpower was used to estimate the sample size; Considering the effect size of 0.8, alpha of 0.5 and power of 0.80, a total of 42 people were obtained for each group of 21 people. Patient samples will be selected using the available method. Participation in the study will be based on their satisfaction and optional, and before completing the research questionnaires, the purpose of the study will be explained to them. Inclusion criteria in the group of patients will be the diagnosis of peptic ulcer symptoms in them through endoscopic diagnostic test. Prior to data collection, the necessary permits will be obtained from the Vice Chancellor for Medical Sciences of Shahid Beheshti University and Taleghani Hospital.
Participants/Inclusion and exclusion criteria
Has not received any psychological intervention in the last 1 year, no personality disorders, no psychotic disorders, no substance abuse, no use of psychiatric drugs.
Intervention groups
Ulcer peptic patients
Main outcome variables
stress coping styles, problem solving, alexithymia, quality of life and pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049252N2
Registration date:2022-01-15, 1400/10/25
Registration timing:registered_while_recruiting
Last update:2022-01-15, 1400/10/25
Update count:0
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
Abbas Masjediarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
a.masjediarani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-03, 1400/08/12
Expected recruitment end date
2022-02-01, 1400/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion regulation training on stress coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer
Public title
The effectiveness of emotion regulation training on stress coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having ulcer peptic
Exclusion criteria:
Psychotic disordr
Age
From 18 years old to 50 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Using another person for treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Yaman blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SBMU.MSP.REC.1400.519
Health conditions studied
1
Description of health condition studied
Ulcer peptic
ICD-10 code
K27.2
ICD-10 code description
Acute peptic ulcer, site unspecified, with both hemorrhage and perforation
Primary outcomes
1
Description
Psychotherapy
Timepoint
3 month
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Excitement regulation protocol This protocol is based on Brooks' 1980 treatment for duodenal ulcer.All patients will receive a manual designed to complete the treatment process. Patients in the treatment group will receive a handbook that (A) Explain the rationale of the treatment plan in terms of the relationship between anxiety, emotional inhibition, and gastric ulcer.B) Graphically shows the constant cycle of worry and anxiety. (C) Identifies several main irrational beliefs that lead to unnecessary anxiety. (D) provide examples of negative self-talk, positive self-talk, and general self-confrontation. E) Explained the concept of decisiveness. (F) provide examples of indecisive, aggressive, and assertive behaviors. (G) Provide space for recording important experiences with newly learned behaviors. And (h) provide charts for recording daily wound pain during the follow-up period.The handbook for control patients will include only (a) a general description of the relationship between anxiety, emotional control, and gastric ulcer, and (b) diagrams for recording daily ulcer pain during the follow-up period.The emotional skills training program consisted of eight 60-90 minute treatment sessions that will be conducted separately with the patients in the treatment group. All treatments will be performed by the first author. Patients will receive four sessions of treatment focusing on anxiety management training and four sessions of rigorous training.Anxiety Management Training: The anxiety management section of the program will follow the proposal of Richardson (1976) and typically, the first four of the eight treatment sessions will be devoted to training. During an initial training phase, the patient, with the help of the therapist (a), examined their irrational, erroneous, and anxious beliefs (Ellis, 1973; Richardson), and negative self-talk about a variety of everyday stressful situations. Will identify and (b) develop and write examples of meaningful, alternative, more realistic, and relaxing personal beliefs and conversations with oneself.Training for courage and assertiveness of emotions: The second 4 sessions will be dedicated to this training. The component of teaching courage and emphatic expression of emotions The emotional skills training program will follow the broad format proposed by Lazarus (1971). The two main stages of this component were (a) cognitive reconstruction focusing on correcting misconceptions about assertiveness and the consequences of non-judgment (with particular reference to wound problems) and (b) practicing the behavior of relevant situations in patients' daily homes and workplaces. For example, most wound patients will report irreversible behaviors in interpersonal situations as a way to "control" emotions and avoid emotional distress (as directed by the therapist). Much of the courage training time will be spent pointing to the need to learn self-awareness, and chronic resentment will be severely emphasized by periodic outbursts of anger and subsequent stressful guilt.
Category
Treatment - Other
2
Description
Control group: Treatment az Usual will be performed in the control group. In this group, once a week for 15 minutes for 6 weeks, the therapist will be in contact with patients, but there will be no major psychological interventions. In this group of patients, attention placebo treatment will be performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Asieeftekhari
Street address
Yaman
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2560 2243
Fax
+98 21 2560 2243
Email
Asie.eftekhari@gmail.com
Web page address
https://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asie eftekhari
Street address
Yaman
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Asie.eftekhari@gmail.com
Web page address
https://msp.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asie Eftekhari
Position
PHD stuedent
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
02123871
Email
Asie.eftekhari@gmail.com
Web page address
https://msp.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas masjedi arani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
asie.eftekhari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas masjedi arani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
+98 21 23871
Email
Asie.eftekhari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is accessible to defined individuals
When the data will become available and for how long
Start of access period of the year 2022
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Review of documents for publishing research articles
From where data/document is obtainable
Researchers present in the research
What processes are involved for a request to access data/document