The study of the effect of Emotion-Focused Therapy on premenstrual syndrome in First year undergraduate students residing in Shaghayegh dormitory’s Shahrood University of Medical Sciences.
(1) Objectives:
o Determine the effect of Emotion-Focused Therapy on premenstrual syndrome.
• Determination of mean score of PMS and mean score of general health in control group and intervention group before intervention, immediately after the intervention, 3 months after the intervention.
(2) design: parallel, two groups, randomized, uncorrected, uncontrolled with medication, single-center, two-stage trials.
(3) Population studied: First year undergraduate students residing in Shaghayegh dormitory’s Shahrood University of Medical Sciences.
(4) Method: Starting from 1/8/96 to 9/1/96. Evaluation before intervention, immediately after the end of the intervention and 3 months after the end of the intervention.
(5) Instruments: Demographic Questionnaire, Premenstrual Symptoms Screening Tool (PSST), General Health Questionnaire (GHQ).
(6) major Inclusion criteria: Confirmation of premenstrual syndrome by acquiring the PSST questionnaire.
(7) major exclusion criteria: (7) major exclusion criteria : pharmaceutical and non-pharmaceutical treatments; history or affection chronic diseases;Incidents of unpleasant during the 3 months prior to the start of the study;Being absent more than one meeting.
(8) Sample size: 50 persons in the intervention group .50 persons in the control group.
(9) Interventions: 4 weekly sessions - 90 minutes. Provide information on the purpose of the study. Anatomy of the female reproductive system. Different stages of preterm delivery. Stress Management Training. Replacing Desirable Behavior Reviewing the Objectives of Answering Questions and Uncertainties.
(10) Outcome: Primary outcome: Determine the mean score PMS in both groups immediately after the intervention and 3 months after the intervention. Secondary Outcome: Determining the mean of general health in both groups immediately after the intervention and 3 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082935980N1
Registration date:2017-09-27, 1396/07/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Zohreh Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 2774
Email address
asghari.z@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of Emotion-Focused Therapy on premenstrual syndrome in First year undergraduate students residing in Shaghayegh dormitory’s Shahrood University of Medical Sciences.
Public title
the effect of Emotion-Focused Therapy on premenstrual syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
major Inclusion criteria: First year undergraduate students residing in dormitory; Confirmation of premenstrual syndrome by acquiring a PSST questionnaire; Satisfaction to participate in the study; Being Iranian; Being Single; Resident living in dormitory; Normal menstruation at least 4 to 8 cycles in the last 6 months.
major exclusion criteria: Regular exercise during the 3 months prior to the start of the study and at the time of study (membership in the sports teams of the province and Participate in regular exercise programs at least three times a week or more for at least 30 minutes); Have a specific diet (vegetarianism, raw food, Hydrotherapy). Drug; Herbal medicine and non-pharmacological treatments (relaxation exercises, yoga, acupuncture, medication) to improve premenstrual problems during the 3 months prior to the start of the study; history or affection chronic diseases,asthma, diabetes, hypertension, epilepsy, Migraine, Thyroid disorders, anemia, cardiovascular disease, Respiratory and Renal Diseases, Neuropsychiatry); Incidents of unpleasant (such as the death of one of the first-degree relatives, severe family disputes, and severe family financial problems) during the 3 months prior to the start of the study; Being absent more than one meeting; acquaintance with Life Skills.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
So far, in Iran, the study on the effect of Emotion-Focused Therapy on premenstrual syndrome has not been done and this approach has been used only in couple relationships.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences, 7'th Tir square, Shahroud.
City
Shahroud
Postal code
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.SHMU.REC.1396.65
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
Determine the mean score PMS in both groups
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Screening Scale for Premenstrual Symptoms (PSST)
Secondary outcomes
1
Description
Determine the mean score of general health in both groups
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
General Health Questionnaire (GHQ)
Intervention groups
1
Description
Intervention in the interventional group:
Four sessions of group training in four consecutive weeks will be set up for 90 minutes with lecture, question and answer and group discussions.
1. The content of the first session will include providing the necessary information on the study and its objectives, providing the necessary training in the description of the female reproductive system, definition of premenstrual syndrome and its causes.
2. At the second session, emotions, emotions and psychological symptoms will be discussed about premenstrual syndrome.
3. The content of the third session will be stress management, coping with stress, avoiding unnecessary stress and replacing situations and accepting things that can not be changed.
4. At the fourth session, the assignments will be reviewed and the answers to questions and uncertainties will be discussed in a lecture, group discussion and question and answer.
Category
Behavior
2
Description
Interventions in the control group:
Four sessions of group training on the topic of genitourinary tract infections in women, will be set up for a period of 90 minutes with lecture, question and answer methods and group discussion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaghayegh dormitory’s Shahrood University of Medical Sciences
Full name of responsible person
Taheri Atefeh
Street address
Shaghayegh dormitory, next to the first door of the army garrison, Shahid Motahari Boulevard.
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Central building of Shahroud University of Medical Sciences, 7'th Tir square, Shahroud.
City
SHahroud
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, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Payam Azadeh
Position
IT expert
Other areas of specialty/work
Street address
7th Tir square, central building of Shahroud University of Medical Sciences
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
emamian@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud
Full name of responsible person
Zohreh Asghari
Position
master's student in midwifery counseling
Other areas of specialty/work
Street address
Shahid Sharif Health Services Center, Meysam Temar St., Shahid Mostafa Khomeini Boulevard, Imam Town.
City
Shahroud
Postal code
Phone
+98 23 3239 2774
Fax
Email
asghari.mid94@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zohreh Asghari
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
Shahid Sharif Health Services Center, Meysam Temar St., Shahid Mostafa Khomeini Boulevard, Imam Town.
City
Shahroud
Postal code
Phone
+98 23 3239 2774
Fax
Email
asghari.mid94@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)