Investigating the effectiveness of cognitive behavioral stress management on pain perception, chronic treatment and cognitive ability of women with fibromyalgia
Investigating the effectiveness of cognitive behavioral stress management on pain perception, chronic treatment and cognitive ability of women with fibromyalgia
Design
A clinical trial with a control group, with factorial groups, randomized in a simple way, with pre-test and post-test, will be conducted on 36 people.
Settings and conduct
The experimental groups will undergo cognitive-behavioral stress management group therapy; But the control group does not receive any intervention. Both the experimental group and the control group are measured twice (pre-test-post-test) separately. The statistical population of this research will be all women with fibromyalgia. The performance will be in Tabriz city and for 8 sessions.
Participants/Inclusion and exclusion criteria
1- Diagnosed with fibromyalgia by a rheumatology specialist, 2- Willingness and informed consent to participate in the research project, 3- Age range 25-60, 4- At least diploma education, 5- Not receiving psychological treatment in the last 6 months.
Intervention groups
18 people will be in the experimental group who will be trained in cognitive-behavioral stress management training classes during 10 90-minute sessions and 18 people will be in the control group who will not receive any intervention.
Main outcome variables
Pain perception, chronicity, and cognitive empowerment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231122060140N1
Registration date:2023-12-20, 1402/09/29
Registration timing:retrospective
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Hossein Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 2182 6483
Email address
rostami.psychologist@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-02, 1402/09/11
Expected recruitment end date
2023-12-09, 1402/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of cognitive behavioral stress management on pain perception, chronic treatment and cognitive ability of women with fibromyalgia
Public title
Investigating the effectiveness of cognitive-behavioral stress management of fibromyalgia sufferers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with fibromyalgia by a rheumatology specialist
Willingness and informed consent to participate in the research project
Age range 25-60
At least diploma education
Not receiving psychological treatment in the last 6 months
Exclusion criteria:
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization - will be randomly assigned to intervention and control groups, and patients will be randomly assigned to two groups of 18 after meeting the entry criteria. The random selection method will be done by lottery and a number will be assigned to each of the sample people, and then the numbers will be randomly selected with the help of Excel software, which will form the test group.
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
Research Ethics Committee of Islamic Azad University- Tabriz branch
Street address
IAUT, Pasdaran Highway, Tabriz-East Azerbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2023-06-23, 1402/04/02
Ethics committee reference number
IR.IAU.TABRIZ.REC.1402.274
Health conditions studied
1
Description of health condition studied
Investigating the effectiveness of cognitive behavioral stress management on pain perception, chronic treatment and cognitive ability of women with fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
"Investigating the effectiveness of cognitive behavioral stress management on pain perception" Pain score in the revised McGill Pain Questionnaire
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
"Investigating the effectiveness of cognitive behavioral stress management on chronic treatment"Chalder Chronic Fatiguescore in Chalder fatigue scale
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
Method of measurement
Chalder Chronic Fatigue Questionnaire (1993)
3
Description
"Investigating the effectiveness of cognitive behavioral stress management on cognitive ability" Psychological empowerment score in Spritzer Psychological Empowerment Questionnaire
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
Method of measurement
Spritzer Empowerment Questionnaire (1995)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 18 people in the experimental group who will be trained in cognitive-behavioral stress management classes in 10 90-minute sessions. The purpose of stress management training is to empower patients to deal with psychological pressure caused by illness, to obtain information about the sources of psychological pressure that generate individual problems, and to teach effective coping skills, including problem-solving training, muscle relaxation skills training, and adjustment and correction of assessment. are inconsistent with the use of cognitive reconstruction.
Category
Treatment - Other
2
Description
Control group: It does not receive any intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology specialist office
Full name of responsible person
Hossein Rostami
Street address
Valiasr West Alley, Manzariyeh Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 914 183 6339
Email
rostami.psychologist@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahim Vakilzadeh
Street address
IAUT, Pasdaran Highway, Tabriz-East Azerbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3196 6000
Email
info@iaut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Hossein Rostami
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Valiasr West Alley, Manzariyeh Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 914 183 6339
Email
rostami.psychologist@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Rostami
Position
Academic board
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Valiasr West Alley, Manzariyeh Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 914 183 6339
Email
rostami.psychologist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Rostami
Position
Academic board
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Valiasr West Alley, Manzariyeh Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 914 183 6339
Email
rostami.psychologist@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD