Determining the effect of counseling with a mindfulness approach on health-promoting behaviors in adolescents with premenstrual syndrome
Design
By cluster sampling method, 4 schools randomly selected, 2 schools of control group and 2 schools of intervention group and among the students who had the criteria to enter the research, 46 people selected by random method.
Settings and conduct
Two control group schools and two intervention group schools and then eligible students are selected with informed consent
Participants/Inclusion and exclusion criteria
Criteria for entering the study: At least 1 year after the onset of the first menstrual period, regular periods with normal intervals in each period (21-35 days), high school girls aged 17-15 years, with moderate to severe premenstrual syndrome ( Score 19 or more in the PSST questionnaire, consent to participate in the intervention, as well as criteria for withdrawal from this study. Irregular menstrual cycle, use of hormonal compounds, chronic mental and physical illness, any medication to relieve the symptoms of premenstrual syndrome, Being under any kind of stressful environmental and psychotherapeutic events and taking psychiatric medications and single parent families
Intervention groups
The sample size was 92 people (46 people in each group) who were randomly selected from the criteria criteria and the intervention group saw mindfulness exercises in 8 sessions and the control group did not see any training.
Main outcome variables
Health promotion; premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200308046720N1
Registration date:2020-06-08, 1399/03/19
Registration timing:retrospective
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Farahnaz Moradymahmodabade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3232 9473
Email address
moradyfarahnaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-10-07, 1398/07/15
Actual recruitment end date
2019-11-06, 1398/08/15
Trial completion date
2020-01-20, 1398/10/30
Scientific title
The effectiveness of consultation based on mindfulness on health promoting behaviors of adolescents with premenstrual syndrome
Public title
The effectiveness of consultation based on mindfulness on health promoting behaviors of adolescents with premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 1 year has passed since the first menstruation
Regular periods with normal intervals in each period (21-35 days)
High school girls aged 17-15
Moderate to severe premenstrual syndrome (score 19 or higher in the PSST questionnaire)
Satisfaction with participating in the intervention
Exclusion criteria:
Irregular menstruation
Consumption of hormonal compounds
Having a chronic mental and physical illness
Medication to relieve the symptoms of premenstrual syndrome
Being under any kind of environmental stressful event
Psychotherapy and the use of psychiatric drugs
Single parent families
Age
From 15 years old to 17 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
92
Actual sample size reached:
92
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Random selection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Yazd University of Medical Sciences
Street address
Saeedi Street
City
Meybod
Province
Yazd
Postal code
8961974360
Approval date
2020-02-20, 1398/12/01
Ethics committee reference number
IR.SSU.REC.1398.209
Health conditions studied
1
Description of health condition studied
Health promotion, premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Behaviors promoting the health of adolescents with PMS
Timepoint
Intervention before, after and one month later
Method of measurement
Walker Health Promotion Lifestyle Questionnaire
2
Description
Behaviors promoting the health of adolescents with PMS
Timepoint
Intervention before, after and one month later
Method of measurement
Walker Health Promotion Lifestyle Questionnaire
Secondary outcomes
1
Description
Premenstrual Syndrome
Timepoint
Before, after and a month after the intervention
Method of measurement
PSST questionnaire
Intervention groups
1
Description
Intervention group:46 Meybod high school girls who meet the criteria for entering the study and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation. The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods.In this study, the intervention group received 8 counseling sessions with a mindfulness approach on a weekly basis for 5.1–2 hours and evaluated the health-promoting behaviors of the intervention group at the beginning of the study, the end of the eighth week, and the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.Counseling Content: Week 1: Automated Guidance, Week 2: Dealing with Obstacles and More Control Reaction to Daily Events, Week 3: Breathing with Mind Presence, Week 4: Present Present, Week 5: Acceptance and Permission, Week 6: Thoughts are not facts, Week 7: Self-care, Week 8: Using what you have learned
Category
Behavior
2
Description
Control group: Meybod's 46 high school girls met the criteria for entering the study, and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation.The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods. In this research, the control group does not see any training and after the end of the research, they will receive all the training of the intervention group. Behavioral health promotion behaviors are assessed at the beginning of the study, at the end of the eighth week, and at the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Meybod High Schools
Full name of responsible person
Farahnaz Moradi
Street address
Saeedi street
City
Meybod
Province
Yazd
Postal code
8961974360
Phone
+98 35 3232 9473
Email
moradyfarahnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Commander Fallahi
City
Yazd
Province
Yazd
Postal code
8961974360
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Moradymahmodabade
Position
Midwif
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Saeedi Street
City
Meybod
Province
Yazd
Postal code
8961974360
Phone
+98 35 3232 9473
Fax
Email
moradyfarahnaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Moradymahmodabade
Position
Midwif
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Saeedi Street
City
Meybod
Province
Yazd
Postal code
8961974360
Phone
+98 35 3232 9473
Fax
Email
moradyfarahnaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Moradymahmodabade
Position
Midwif
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Saeedi Street
City
Meybod
Province
Yazd
Postal code
8961974360
Phone
+98 35 3232 9473
Fax
Email
moradyfarahnaz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available