Objective: This study will be designed to reduce depression and anxiety with comparison of the effectiveness of group cognitive behavioral therapy and group cognitive hypnotism in women with premenstrual syndrome.
Materials and Methods: The research will be done semi-experimental method on women and girls who will client to 12 Health center of Rasht city in 2016.
Premenstrual syndrome (PMS) is defined as a set of physical and psychological symptoms that occur during the Luteal phase of the menstrual cycle. Among this complaint, depression and anxity are more common and aversive. Available sampling will be used for this purpose and 30 women with premenstrual syndrome will be selected and divided to 3 group into 2 Experimental group and 1 control group randomly. Inclusion criteria will be fertility and premenstrual syndrome and exclusion criteria will be negative test Spiegel. The first experimental group will receive 8-week group cognitive behavioral therapy. Also the second group will receive, hypnosis cognitive therapy and the third group will not receive special treatment. 8 item Premenstrual syndrome inventory and the Beck’s questionnaires depression and anxiety will be used in pre-test and Post- test. Covariance analysis and Tukey will be used to analyze the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090228931N1
Registration date:2016-09-02, 1395/06/12
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Leila Moghtader
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3350 1139
Email address
moghtaderleila@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Rasht Azad University of Medical Sciences
Expected recruitment start date
2016-09-19, 1395/06/29
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of group cognitive behavioral therapy and group cognitive hypnotism for anxiety in women with premenstrual syndrome
Public title
cognitive hypnotism for anxiety in women with premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of fertility; premenstrual syndrome;
Exclusion criteria: negative test Spiegel
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After sampling, two experimental groups and one control group will be separat by lottery
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rasht Azad University of Medical Sciences
Street address
Rasht, Pole Taleshan, Azad University
City
Rasht
Postal code
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.IAU.RASHT.REC.1395.7
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Depression
Timepoint
Before and after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Anxity
Timepoint
Before and after the intervention
Method of measurement
Beck Anxity Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The first experimental group: eight 2-hour sessions of cognitive behavior therapy
Category
Behavior
2
Description
The first experimental group: eight 2-hour sessions of Cognitive Hypnotherapy
Category
Behavior
3
Description
No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Holistic Nursing Research Center
Full name of responsible person
Sedigheh Pakseresht
Street address
Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Gilan University of Medical Sciences
Full name of responsible person
Sedigheh Pakseresht
Street address
Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
City
Rasht
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 Gilan 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
Azad University
Full name of responsible person
Leila Moghtader
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasht, pole Taleshan, Azad University
City
Rasht
Postal code
Phone
+98 13 3350 1139
Fax
Email
moghtaderleila@yahoo.com moghtader@iaurasht.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad University
Full name of responsible person
Leila Moghtader
Position
ph.D psychology
Other areas of specialty/work
Street address
Rasht, Paul Taleshan, Islamic Azad University
City
Rasht
Postal code
Phone
+98 13 3350 1139
Fax
Email
moghtaderleila@yahoo.commoghtader@iaurasht.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad University
Full name of responsible person
Leila Moghtader
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasht, Paul Taleshan, Islamic Azad University
City
Rasht
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)