The purpose of this study is to recognize the effectiveness of mindfulness-based cognitive-behavioral therapy on premenstrual syndrome (PMS). This study, as a clinical design, is carried on 40 women with PMS. Inclusion criteria are: Women 18- 35 years old؛ Availability during the next 6 months؛ Scale score between 33-64 of the premenstrual syndrome؛ being single .And exclusion criteria are: Cases diagnosed mental illness ؛Addiction to alcohol, drugs and other psychotropic drugs ؛The absence of more than three days؛ Studying counseling and psychology. Data are analyzed using questionnaire of premenstrual syndrome. As the necessary score is obtained through questionnaires, women are divided randomly into two experimental and control groups (20 in each group (. The intervention group receives 8 weeks 1-hour sessions for mindfulness-based cognitive-behavioral counseling conducted by researcher. After the end consultation and one month later, both groups reassess using questionnaire of Premenstrual Syndrome. The primary outcome of this study is to improve the symptoms of premenstrual syndrome in women in experimental group based on questionnaire score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110630750N1
Registration date:2016-12-09, 1395/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Saeedeh Askari
Name of organization / entity
Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 4173
Email address
askari.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive behavioral treatment on premenstrual syndrome
Public title
The effect of mindfulness-based cognitive behavioral treatment on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women 18- 35 years old; Availability during the next 6 months; Scale score between 33-64 of the premenstrual syndrome; being single
Exclusion criteria: Cases diagnosed mental illness; Addiction to alcohol, drugs and other psychotropic drugs; The occurrence of adverse events (death of loved ones, accidents with disabilities.) During the consultation or earlier; Chronic diseases (diabetes, hypertension, epilepsy, etc.); The absence of more than three days; Studying counseling and psychology
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Department of Research and Information Technology of Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
IR.AJUMS.REC. 1395 .437
Health conditions studied
1
Description of health condition studied
premenstural syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Premenstrual Syndrome
Timepoint
Before intervention, immediately after intervention, a month after the intervention.
Method of measurement
Premenstrual Syndrome Scale
Secondary outcomes
1
Description
Physical Symptoms of Premenstrual Syndrome
Timepoint
Before intervention, immediately after intervention, one month after the intervention.
Method of measurement
Questionnaire physical symptoms of Premenstrual Syndrome
2
Description
Psychological symptoms – behavioral of Premenstrual Syndrome
Timepoint
Before intervention, immediately after intervention, one month after the intervention.
Method of measurement
Questionnaire psychological - behavioral symptoms of Premenstrual Syndrome
Intervention groups
1
Description
The intervention group received eight sessions of mindfulness-based cognitive-behavioral therapy helps. Each session is 60 minutes long and has a specific structure.
Category
Behavior
2
Description
The control group did not work and were on a waiting list.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Masumeh Dormitory of Chamran University Ahvaz
Full name of responsible person
Saeedeh Askari
Street address
Golestan Blvd, Ahvaz, Khuzestan Province
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharief Makhmal
Street address
Ground Floor, Vice Chancellor For Research Of Ahvaz Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For research Of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saeedeh Askari
Position
Master Student of Consultation in Midwifery
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Sciences, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3373 8621
Fax
Email
askari.s@ajums.ac.irsaedehaskare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Abbaspoor_Z762@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saeedeh Askari
Position
Master Student of Consultation in Midwifery
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 84 3362 4173
Fax
Email
Saedehaskare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)