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Effects of Cognitive- Behavioral Therapy on Health Related Quality of Life of Females with Premenstrual Syndrome

Protocol summary

Summary
Objectives: The purpose of this study is to investigate the effects of Cognitive- Behavioral Therapy on health related quality of life in female students of Shahid Chamran University with premenstrual syndrome. Design: The design of the study is pre and posttest with control group. Participants including major eligibility criteria: The sample of the study will consist of 40 students with PMS whom were randomly, and according to inclusion criteria, assigned to an intervention or a control group. Inclusion criteria consist of having regular menstrual cycles (24-35days); do not taking hormonal, psychotropic, vitamins, oral contraceptives at the time; not being pregnant or lactating; not experiencing stressors such as marriage, surgery, death of relatives, and etc. during the previous three months; not being under any kind of treatment to relieve the symptoms during the study and not having internal, gynecological, and psychiatric disorders. Exclusion criteria are absence of the above conditions. Intervention: Participants in the intervention group will receive 10 sessions of Cognitive- Behavioral Therapy. Women in control group will not receive any intervention. Main outcome measures (variables): Primary outcome measure is health related quality of life. The scale for assessing health related quality of life will be administered on both groups at pretest, posttest, and the follow-up stages (2 months after the treatment).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062822960N1
Registration date: 2015-10-21, 1394/07/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Maryam Izadi-Mazidi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 917 134 6040
Email address
m.izadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vicechancellor for research, Shahid Chamran University of Midical Sciences
Expected recruitment start date
2015-07-31, 1394/05/09
Expected recruitment end date
2016-07-30, 1395/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cognitive- Behavioral Therapy on Health Related Quality of Life of Females with Premenstrual Syndrome
Public title
Effect of Cognitive Behavioral Therapy on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having regular menstrual cycles (24-35days); do not taking hormonal, psychotropic, vitamins, oral contraceptives at the time; not being pregnant or lactating; not experiencing stressors such as marriage, surgery, death of relatives, and etc. during the previous three months; not being under any kind of treatment to relieve the symptoms during the study and not having internal, gynecological, and psychiatric disorders. Exclusion criteria: Absence of the above conditions.
Age
No age limit
Gender
Female
Phase
2-3
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

1

Registry name
...........
Secondary trial Id
.............
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Chamran University of Medical Sciences
Street address
Department of education and graduate, Shahid Chamran University, Golestan, Ahvaz city, Khozestan province
City
Ahvaz
Postal code
Approval date
2011-01-19, 1389/10/29
Ethics committee reference number
No:2030778

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Health Related Quality of Life
Timepoint
Before intervention, 70 days after the start of intervention, 2month after the end of intervention
Method of measurement
Health Related Quality of Life Questionaire

Secondary outcomes

1

Description
Premenstrual Syndrome
Timepoint
before intervention, 70 days after the start of intervention, 2 month after the end of intervention
Method of measurement
Daily Record of Severity of Problems

Intervention groups

1

Description
Intervention group: Participants in the intervention group, will receive ten weekly 90-minute group cognitive-behavioral therapy sessions (each session, 90 minutes ). The intervention will consist of relaxation, PMS attribution training, challenging beliefs, stress management, education on diet and problem solving.
Category
Treatment - Other

2

Description
control group: The subjects of control group received no interventions until the end of the study
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
ُShahid Chamran University
Full name of responsible person
Maryam Izadi-Mazidi
Street address
Shahid Chamran University of Medical Sciences, Golestan, Ahvaz city, Khozestan province
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vicechancellor for research, Shahid Chamran University of Midical Sciences
Full name of responsible person
Ebrahim Hajidavalloo
Street address
Vicechancellor for research, Shahid Chamran University, Golestan, Ahvaz city, Khozestan province
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vicechancellor for research, Shahid Chamran University of Midical 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
Shahed University
Full name of responsible person
Maryam Izadi-Mazidi
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
Shahed University, In front of Behesht-e Zahra, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
3319118651
Phone
+98 215121362
Fax
Email
Maryam.izadi.psy@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Izadi-Mazidi
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
Shahed University, In front of Behesht-e Zahra, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
3319118651
Phone
+98 215121362
Fax
Email
Maryam.izadi.psy@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Izadi-Mazidi
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
Shahed University, In front of Behesht-e Zahra, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
3319118651
Phone
+98 215121362
Fax
Email
Maryam.izadi.psy@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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