Comparison of the effectiveness of Hypnotherapy, Cognitive-Behavioral therapy (CBT) and Cognitive-Behavioral Hypnotherapy (CBH) treatment on Resilience, Sleep quality, Sexual satisfaction and Physical symptoms in women with Fibromyalgia syndrome
Determining the effectiveness of Cognitive_Behavioral Hypnotherapy treatment on Sleep quality, Resiliency, Sexual satisfaction and Physical symptoms in women with Fibromyalgia Syndrome
Determining the effectiveness of Cognitive_Behavioral therapy on Sleep quality, Resiliency, Sexual satisfaction and Physical symptoms in women with Fibromyalgia Syndrome
Determining the effectiveness of Hypnotherapy treatment on Sleep quality, Resiliency, Sexual satisfaction and Physical symptoms in women with Fibromyalgia Syndrome
Design
Clinical trial with 3 intervention groups and 1Control group with Parallel group on 12 patients that were randomly distributed among 4 group which contained 3 persons.
Settings and conduct
In this research, the dependent variable is measured several times during the baseline phase and treatment phase. For the measurement of baseline at least 3 times measurement is necessary. In this way before performing the independent variable, the dependent variable should be measured since 20 days before performance to the exact day of introductory session. The results must be compared with each other.
Participants/Inclusion and exclusion criteria
Enter:
Not receiving coherent psychological therapies.
Married women between at least 20 to 60 years old
Diploma degree at least
Agreement of the patient for the research and signature of consent form
Do not enter:
Having Psychotic disorder
Single ones
Less than 20 and above 60 years old
Intervention groups
First group: Hypnotherapy_based intervention
Second group: Intervention based on Cognitive_Behavioral therapy
Third group: Intervention based on Cognitive_Behavioral Hypnotherapy treatment
Forth group: Control without intervention
Main outcome variables
Resiliency, Sleep quality, Sexual Satisfaction, Physical Symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191130045558N1
Registration date:2020-08-02, 1399/05/12
Registration timing:registered_while_recruiting
Last update:2020-08-02, 1399/05/12
Update count:0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Mahdieh Kolbadinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 3853
Email address
mkolbadi483@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-26, 1399/05/05
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Hypnotherapy, Cognitive-Behavioral therapy (CBT) and Cognitive-Behavioral Hypnotherapy (CBH) treatment on Resilience, Sleep quality, Sexual satisfaction and Physical symptoms in women with Fibromyalgia syndrome
Public title
Comparison of the effectiveness of Hypnotherapy, Cognitive-Behavioral therapy (CBT) and Cognitive-Behavioral Hypnotherapy (CBH) treatment on Resilience, Sleep quality, Sexual satisfaction and Physical symptoms in women with Fibromyalgia syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving coherent psychological therapies.
Married women
Age 20 to 60
Having a minimum level of diploma education
Patient consent to participate in the study and sign a written consent
No Psychotic disorder
No substance abuse
No serious medical illnesses; Includes severe liver and kidney failure
Not having serious thoughts of self harm and debtors
Not having Antisocial personality disorder
Exclusion criteria:
Serious thoughts of harming yourself and others
Having severe liver and kidney failure
Having Antisocial Personality disorder
Substanse abuse
Having Psychotic Disorders
Single women
Less than 20 and above 60 years old
Under diploma degree
20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy
Method of measurement
Paul and Enrit Physical Symptoms Questionnaire
2
Description
Resiliency
Timepoint
20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy
Method of measurement
Conner and Davidson Resiliency Questionnaire
3
Description
Sleep Quality
Timepoint
20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy
Method of measurement
Peterzburg Sleep Quality Questionnaire
4
Description
Sexual Satisfaction
Timepoint
20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy
Method of measurement
Roshan Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually.
Category
Treatment - Other
2
Description
Second Intervention group: Cognitive_Behavioral Therapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually.
Category
Treatment - Other
3
Description
Third Intervention group: Cognitive-Behavioral Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually.
Category
Treatment - Other
4
Description
Control group: Without intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Aghaee Rheumatology Clinic
Full name of responsible person
Dr. Mehrdad Aghaee
Street address
No. 14, Edalat st.
City
Gorgan
Province
Golestan
Postal code
4916818933
Phone
+98 17 3252 3853
Email
Mkolbaadi483@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice president for Research and technology
Street address
Daneshjoo St.
City
Gorgan
Province
Golestan
Postal code
4914739975
Phone
+98 17 3215 3000
Email
Mkolbadi483@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad uiversity of Gorgan
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
Islamic Azad University
Full name of responsible person
Mahdieh Kolbadinejad
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, 16 street, golshar blvd
City
Gorgan
Province
Golestan
Postal code
4916818933
Phone
+98 17 3252 3853
Fax
Email
Mkolbadi483@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Pourasghar Arabi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 7, 16 street, golshar blvd
City
Sari
Province
Mazandaran
Postal code
4916818933
Phone
+98 17 3252 3853
Fax
Email
Me_Pourasghar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdieh Kolbadinejad
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, 16 street, golshar blvd
City
Gorgan
Province
Golestan
Postal code
4916818933
Phone
+98 17 3252 3853
Fax
Email
Mkolbadi483@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
the whole research
When the data will become available and for how long
3month after published
To whom data/document is available
psychologists
psychiatrists
physitions
Under which criteria data/document could be used
for scientific researches
From where data/document is obtainable
mkolbadi483@gmail.com
What processes are involved for a request to access data/document