Evaluation of family-centered psychological intervention program on spiritual vitality, marital satisfaction and migraine disorder syndrome in married people
Design
Clinical trial with one control group and one intervention group, with parallel groups, designed for 30 patients, Simple randomization with a table of random numbers
Settings and conduct
This study is performed in patients with migraine in the subspecies pain clinic. In this study, blinding has not been done
Participants/Inclusion and exclusion criteria
The diagnosis of migraine disorders should be confirmed based on the clinical diagnosis of migraine in patients.
Having a high school education
Being between 40 to 55 years old
Absence of a history of neurological disorders and a history of hospitalization in a psychiatric hospital
No substance abuse
Being married
Willingness to cooperate
Intervention groups
1. In the experimental group, a family-centered psychological intervention program was implemented based on Lidl's family-centered therapy protocol. 2. The control group did not receive any therapeutic intervention as a witness of the research.
Main outcome variables
Spiritual vitality, marital satisfaction and migraine disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220625055272N1
Registration date:2023-02-15, 1401/11/26
Registration timing:retrospective
Last update:2023-02-15, 1401/11/26
Update count:0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Negar Sheikhli
Name of organization / entity
University of Tehran Kish International Campus
Country
Iran (Islamic Republic of)
Phone
+98 21 3223 5011
Email address
sheikhlinegar34@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-21, 1401/05/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy a family- based psychological intervention program on spiritual happiness, marital satisfaction and migraine disorder syndrome couples
Public title
Developing and Effectiveness a family- based psychological intervention program on spiritual happiness, marital satisfaction and migraine disorder syndrome couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40-50 years
The diagnosis of migraine disorders should be confirmed based on the clinical diagnosis of migraine in patients.
Not using other treatment psychotherapy programs and changing medications during the research
Being married
Willingness to cooperate
No substance abuse
Exclusion criteria:
Psychological treatment in the last 6 months
Severe mental disorder Failure to respond to the therapist for two weeks in a row
participants suffering from other physical diseases
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers in the group division Randomized allocation in clinical trial studies refers to randomly dividing participants into different groups. Randomizing gives each participant equal odds of being placed in each group. Forty migraine patients are selected randomly in the centers. The randomization tool is a random table of numbers in which the researcher moves the numbers right and downward on one of the numbers, finally recording the numbers and dividing them into two experimental groups of twenty people and determining the control group (twenty people) whose number has already been established.
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 the Faculty of Psychology and Educational Sciences, University of Tehran
Street address
Kish Campus: Mirmahna Blvd. - the beginning of Niayesh St. - Kish International Campus of Tehran University
City
Kish
Province
Hormozgan
Postal code
1358879331
Approval date
2022-06-05, 1401/03/15
Ethics committee reference number
IR.UT.PSYEDU.REC.1401.034
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Pain syndrome
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
Pain Disability Index Questionnaire
Secondary outcomes
1
Description
Spiritual vitality
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
Spiritual Vitality Scale (Afrooz, 2016)
2
Description
Marital satisfaction
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
Marriage Satisfaction Questionnaire
Intervention groups
1
Description
Family-centered psychological interventions program by recognizing and respecting the existence of the family and promoting the competence and confidence of the family in taking care of themselves and the patient, and empowering the family to support the patient in the compromise with the care and treatment system, according to the focus of the education of the enhancing lifestyle Health and its maintenance, adherence to treatment, interpersonal communication, stress management and prevention of disease progression were compiled with the participation of the family and with a holistic approach. In the present study, after developing a package of family-oriented psychological interventions, this program was conducted in 8 sessions of 1.5-2 hours per week, with the educational participation of the spouse of the affected person and the affected person, and the transfer of information through educational booklets and audio CDs. ) was done as a group.
Category
Behavior
2
Description
Control group: Only taking medication was prescribed by a neurologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Pain Specialized Clinic
Full name of responsible person
Negar Sheikhli
Street address
Gilan province, Rasht, Golsar boulevard, Bint Al-Huda, between Amani and Zand dead end. Mehr Pain Specialized Clinic
City
Rasht
Province
Guilan
Postal code
1358879331
Phone
+98 34 4326 3329
Email
sheikhlinegar34@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Shirin Naderi
Street address
Kish Campus: Mirmahna Blvd. - the beginning of Niayesh St. - Kish International Campus of Tehran University
City
Kish
Province
Hormozgan
Postal code
13588784612
Phone
+98 34 1822 0795
Email
info@kiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tehran
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
The University of Tehran
Full name of responsible person
Negar Sheikhli
Position
PhD student of Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
پردیس کیش: بلوار میرمهنا - ابتدای خیابان نیایش - پردیس بین المللی کیش دانشگاه تهران
City
Tehran
Province
Guilan
Postal code
1358879331
Phone
+98 34 4326 3329
Email
sheikhlinegar34@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Negar Sheikhli
Position
PhD student of Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kish Campus: Mirmahna Blvd. - the beginning of Niayesh St. - Kish International Campus of Tehran University
City
Tehran
Province
Guilan
Postal code
1358879331
Phone
+98 34 4326 3329
Email
sheikhlinegar34@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Negar Sheikhli
Position
PhD student of Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Gilan province, Rasht, Golsar boulevard, Bint Al-Huda, between Amani and Zand dead end. Mehr Pain Specialized Clinic
City
Rasht
Province
Guilan
Postal code
1358879331
Phone
009843263329
Email
sheikhlinegar34@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 related data to participants are shared after hiding patient's name.
When the data will become available and for how long
The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles.
To whom data/document is available
The present study data will be available only to researchers working in the academic and scientific institutions.
Under which criteria data/document could be used
The output of statistical analysis will be available
From where data/document is obtainable
Applicants can apply for documentation and data via email at sheikhlinegar34@gmail.com
What processes are involved for a request to access data/document
After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later.