The effectiveness comparison of auriculotherapy with the cognitive therapy based on mindfulness in treatment of premenstrual syndrome in female students
The aim of this study was to determine and comparison of auriculotherapy with the cognitive therapy based on mindfulness in treatment of premenstrual syndrome in female students.
Inclusion criteria: female students living in dormitories University of Medical Sciences; Having two healthy ears (for auriculotherapy); no history or treatment of disorders like depression or anxiety; eating disorders; anemia; thyroid disease; diabetes; lack of birth control pills for medical reasons; Not taking any herbal medicine and effective treatment of premenstrual syndrome; Not treated with drugs; mental disorders and other non-pharmacological methods; Having at least 30% increase in severity of symptoms within 5 days before menstruation; Non-participation in another related study until the completion of the current study period.
Exclusion criteria: Premenstrual Dysphonic disorder.
Research community: Girls with premenstrual syndrome.
The sample size in this Clinical trial is 84 girls will be elected with sampling targeted among students who counting inclusion criteria and randomized allocated into three groups by computer randomly. Data will be collected for pre-test, post-test, So that Premenstrual syndrome screening tool will be completed by the research units in three groups, in the first session before the intervention, at the end of week eight and the twelfth week after the start of the study. Follow-up sessions will be done by the researcher with the consent of the subjects via SMS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051330897N2
Registration date:2017-06-27, 1396/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Batoul Ghaedamini
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 3821
Email address
bghamini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shahid Sadoughi University of Medical Science
Expected recruitment start date
2016-04-17, 1395/01/29
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 effectiveness comparison of auriculotherapy with the cognitive therapy based on mindfulness in treatment of premenstrual syndrome in female students
Public title
The effectiveness comparison of auriculotherapy with the cognitive therapy based on mindfulness in treatment of premenstrual syndrome in female students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female students living in dormitories University of Medical Sciences; Having two healthy ears (for auriculotherapy); no history or treatment of disorders like depression or anxiety; eating disorders; anemia; thyroid disease; diabetes; lack of birth control pills for medical reasons; Not taking any herbal medicine and effective treatment of premenstrual syndrome; Not treated with drugs; mental disorders and other non-pharmacological methods; Having at least 30% increase in severity of symptoms within 5 days before menstruation; Non-participation in another related study until the completion of the current study period.
Exclusion criteria: Premenstrual dysphoric disorder.
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:
84
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
Shahrekord University of Medical Sciences
Street address
Ayatollah Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.SKUMS.REC.1394.321
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
F50
ICD-10 code description
Eating disorders
2
Description of health condition studied
Premenstural Syndrome
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
3
Description of health condition studied
Premenstural Syndrome
ICD-10 code
F54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
4
Description of health condition studied
Premenstural Syndrome
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
Premenstrual syndrome
Timepoint
Before the intervention, after intervention and one month after intervention
Method of measurement
Premenstrual syndrome screening tool
Secondary outcomes
empty
Intervention groups
1
Description
The first group (intervention): Perform 8 Sessiones of Auriculotherapy once a week, stimulate pointes of both ears for 5 to 15 seconds by (Excel Pointer) at every meeting. After Auriculotherapy in each session, put seed on points for 2 to 3 days on the ears and recommend, press seed every 2 hours for 1-2 minutes.
Category
N/A
2
Description
The second group (intervention): Perform 8 sessions of Mindfulness based cognitive behavioral therapy once a week for 90-120 minutes.
Category
N/A
3
Description
Control group: Before intervention, Week Eight and The twelfth week after the intervention, Will be completed the screening tool premenstrual syndrome. this group will not receive any intervention. but the effectiveness of each interventions, after the end of the study, at The twelfth week If them want, will be given the necessary training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sisters Dorm of Shahrekord University of Medical Sciences
Full name of responsible person
Batoul Ghaedamini
Street address
Residences Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Science
Full name of responsible person
Mojgan Sharify
Street address
School of Nursing and Midwifery, Boualli Sina Alley, Teamsar Fallahi Street, Safaieh, Yazd
City
Yazd
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 Shahid Sadoughi University of Medical Science
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
shaheid sadoughi University of Medical Sciences
Full name of responsible person
Btoul ghaeidamini
Position
MAS Student of Midwifery Counseling
Other areas of specialty/work
Street address
School Nursing of and Midwifery, Boualli Sina Alley, Teamsar Fallahi Street, Safaieh, Yazd
City
yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
bghamini@yahoo.com; bghamini@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Tahmineh Farajkhoda
Position
PHD in reproductive health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Boualli Sina Alley, Teamsar Fallahi Street, Safaieh, Yazd
City
yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
farajkhoda_t@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
batoul ghaeidamini
Position
MAS Student of Midwifery Counseling
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Boualli Sina Alley, Teamsar Fallahi Street, Safaieh, Yazd
City
Yazd
Postal code
Phone
+98 913 980 3861
Fax
Email
bghamini@yahoo.com; bghamini@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)