The aim of this study is The Effectiveness of Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of Premenstrual Syndrome (PMS)
Design
Clinical trial, without control group, without blinding, randomized on three patients
Settings and conduct
Screening to find samples is done at Binish Consulting Center in Ahvaz.3 selected samples are randomly determined as the first, second, third. Cognitive behavioral therapy is performed as 8 sessions of 90 minutes and once a week based on the package "Effect of Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of PMS.In the first session, people complete the questionnaires of Young's schema and Toronto Alexithymia scale-20at the beginning of the study.48 hours after the end of the intervention, the participants complete the questionnaires again
Participants/Inclusion and exclusion criteria
Inclusion criteria included: Age 18-45 years- Cycle education-Confirmation of premenstrual syndrome with moderate to severe severity
Intervention groups
Cognitive behavioral therapy is carried out in 8 sessions of 90 minutes and once a week based on the package "Effect Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of premenstrual syndrome" in the intervention group
Main outcome variables
severity of premenstrual symptoms; premenstrual behavioral symptoms; depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220713055457N3
Registration date:2022-11-07, 1401/08/16
Registration timing:registered_while_recruiting
Last update:2022-11-07, 1401/08/16
Update count:0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Zohreh Ahmady
Name of organization / entity
Islamic Azad Univercity Behbahan Branch
Country
Iran (Islamic Republic of)
Phone
+98 916 982 5673
Email address
zohreh.ahmady@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2022-11-13, 1401/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of Premenstrual Syndrome (pms)
Public title
The Effectiveness of Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of Premenstrual Syndrome (pms)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years
Cycle education
Confirmation of premenstrual syndrome with moderate and severe severity
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Behbahan Branch
Street address
Shahid Bayani Ave.,AmirKabir Blvd.,Behbahan City
City
Ahvaz
Province
Khouzestan
Postal code
6361713198
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.IAU.BEHBAHAN.REC.1401.016
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of premenstrual syndrome symptoms
Timepoint
before and 48 hours after the end of the intervention
Method of measurement
Young's schema(YSQ-SF) and Toronto Alexithymia scale-20 questionnaire
Secondary outcomes
1
Description
Behavioral symptoms related to premenstrual syndrome
Timepoint
before and 48 hours after the end of the intervention
Method of measurement
Young's schema and Toronto Alexithymia scale-20 Questionnaires
Intervention groups
1
Description
Intervention group: 3 selected samples are randomly determined as the first, second, third. Cognitive behavioral therapy is performed as 8 sessions of 90 minutes and once a week based on the package "Effect of Yoga Therapy on Early Maladaptive Schemas and Emotional Distress of PMS"
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Binesh Consulting Center
Full name of responsible person
Leyla Jazayeri
Street address
No. 20,West 7th Street,Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1239876547
Phone
+98 916 844 8839
Email
zohrehahmady2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahrooei
Street address
Shahid Bayani Ave.,AmirKabir Blvd.,Behbahan City
City
Ahvaz
Province
Khouzestan
Postal code
6361713198
Phone
+98 61 5287 0109
Email
zohrehahmady2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Zohre Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available