Determining the Effect of Lovantal Self-Regulatory Model on Menstrual Distress in Young Adolescent Girls aged 14-19 in Qazvin in 1398
Design
Controlled clinical trial
Settings and conduct
From each section, a school attendee will be an intervention group and a control group school. An initial assessment of the severity of dysmenorrhea and menstrual pain in both groups will take place two months and then one month before the intervention. In the intervention group, based on The Leventhal model is based on the results of the sub-scales of the completed questionnaires by the girls, the educational content will be provided. The number of these sessions for the three sessions of the test group and the duration of each session is 60 Å 90 minutes and three consecutive weeks (in groups of 10 to 8), once a month after the completion of the sessions and once every three months by each The two groups will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: living in Qazvin, Age 14-19, high school student, Having regular menstruation, experiencing at least 2 years of menstruation, Menstrual pain 4 or more than 4 based on visual analouge scale
Exclusion criteria: having secondary dysmenorrhea and its causes, history of known mental illnesses, Substance abuse history (self-declaration), Surgery related to gynecological problems, being married, No desire to participate in the study, Take special medication in the last 6 months, No attendance at all educational sessions .
Intervention groups
Teenage girls studying in high school
Main outcome variables
Menstrual distress
General information
Reason for update
Acronym
Leventhal model study
IRCT registration information
IRCT registration number:IRCT20190625044002N1
Registration date:2019-09-03, 1398/06/12
Registration timing:prospective
Last update:2019-09-03, 1398/06/12
Update count:0
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Somaye Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3349 0267
Email address
s.asgari71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementation of Leventhal self-regulation model on menstrual distress among adolescent girls
Public title
Investigating the effect of implementation of Leventhal self-regulation model on menstrual distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The resident of Qazvin
Have regular menstruation
Experience at least 2 years of menstruation
Severity of pain in menstruation 4 or more than 4
Enroll in high school
Ages 14 to 19 years
Exclusion criteria:
The presence of secondary dysmenorrhoea and its underlying causes
2. History of known mental illnesses
Substance abuse history (self-declaration)
Surgical history of women
Being Married
Unwilling to participate in the study
. Mandatory drug use in the last 6 months
Not attending meetings (attendance at all meetings is obligatory)
Age
From 14 years old to 19 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Because the presence of intervention and control group members in a school is likely to cause information leakage, random group assignment will be made. For this purpose, two schools will be randomly selected for intervention group and two schools will be randomly selected for control group.Random allocation will be done by simple random method using random number table.
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
Ethics Committee of Qazvin University of Medical Sciences
Street address
Ghazvin, Shahid Bahonar Blvd. Ghazvin University of Medical Sciences
City
قزوین
Province
Qazvin
Postal code
3497135631
Approval date
2019-05-26, 1398/03/05
Ethics committee reference number
IR.QUMS.REC.1398.043
Health conditions studied
1
Description of health condition studied
Menstural distress
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
menstrual distress
Timepoint
Measurement of menstrual distress before intervention, one month and three months after intervention
Method of measurement
Moos menstrual distress questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Learning based on the Leventhal self-regulation model.Based on the Leventhal coordinate model and the results obtained from the subscales of the questionnaires completed by the girls, educational content will be provided. The number of sessions for the test group will be three sessions and the duration of each session is 60 to 90 minutes. In the first session, after initial communication with the patient, questions will be asked about their understanding and understanding of the current disease and its consequences. The meeting is based on five dimensions of understanding the illness and the impact of understanding the disease on psychological outcomes. These dimensions will include the nature of the disease (symptoms related to illness such as fatigue, weakness), the cause of the disease, the duration or perception of the individual during the illness, the outcome and expected outcomes of the disease, the effectiveness of control, treatment and improvement of the disease. Interventions for understanding illness will include self-control techniques, verbal encouragement, goal-setting (eg, reducing stress with exercise), feedback, and evaluating behaviors, using successful people's experiences in the field. In the second session, after reviewing the patient's pre-session training, she will be asked to talk about her feelings and ambiguities. Training will be designed to change the negative and negative perceptions of the disease. Patients will be asked to ask the researcher if there is a question from the previous session. The final 30 minutes of stress and relaxation strategies will be taught for 30 minutes. Participants will be asked to practice these techniques. Third Session (Evaluation and Closure): The patient will be informed of the closure of the previous session. First, the training sessions are reviewed, and the patient will be asked about the impact of new training and experiences. Problems and obstacles for each patient will be reviewed, exercises for the previous session will be repeated, and participants' questions will be answered. At the end of the third session a booklet will be provided to the patient including issues such as disease identification and definition, personal hygiene, physical activity and exercise, a brief explanation of the misconceptions about menstruation developed by the researcher.
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin city High schools
Full name of responsible person
Somaye Asgari
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Ghazvin, Shahid Bahonar Blvd. Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3497135631
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Somaye Asgari
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
somaye
Position
master student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
somaye Asgari
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data will be published as an attachment in the article after being unidentifiable
When the data will become available and for how long
After completing the study and simultaneously publishing the results
To whom data/document is available
All researchers interested in the subject of research
Under which criteria data/document could be used
Written request for reasons requiring the use of data to be sent to the author
From where data/document is obtainable
Corresponding to the author
What processes are involved for a request to access data/document