To determine the effect of the Lundal self-regulation model on Illness perception and severity of primary dysmenorrhea in adolescent girls 14-14 years old in Qazvin in 2019
Design
The clinical trial with a control group, parallel, not blind, randomized
Settings and conduct
Our study population is adolescent girls. After enrolling in the study, two schools for intervention, two control schools will participate. Initial assessment of the severity of dysmenorrhea and menstrual distress will be done in both groups two months and then one month before the intervention. The intervention will consist of three sessions. The questionnaire will be completed by both groups once a month and two and three months later. There will also be a training session for the control group after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have regular menstruation; experience at least 2 years of menstruation; severity of pain in menstruation 4 or more than 4. Exclusion criteria: presence of secondary dysmenorrhea; history of known mental illnesses; substance abuse history; surgical history of women; being Married; unwilling to participate in the study; not attending meetings.
Intervention groups
The intervention group will receive three sessions and each session lasts 60 to 90 minutes and three consecutive weeks in the form of a psycho-educational intervention.The control group will receive a training class after the intervention.
Main outcome variables
Severity of primary dysmenorrhea; illness perception
General information
Reason for update
Acronym
Leventhal model study
IRCT registration information
IRCT registration number:IRCT20190625044002N2
Registration date:2020-01-06, 1398/10/16
Registration timing:prospective
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
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
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of the implementation of Leventhal self-regulation model on Illness perception and pain severity of primary dysmenorrhea
Public title
Influence of the implementation of Leventhal self-regulation model on Illness perception and pain severity of primary dysmenorrhea
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 old
Exclusion criteria:
The presence of secondary dysmenorrhoea and its underlying causes
History of known mental illnesses
Substance abuse history (self-declaration)
Surgical history of women
Unwilling to participate in the study.
Being Married
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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Qazvin
Province
Qazvin
Postal code
3497135631
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.QUMS.REC.1398.225
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Pain intensity of primary dysmenorrheal
Timepoint
Measurement of menstrual pain intensity one and two months before the intervention, one month and three months after the intervention
Method of measurement
Measurement of menstrual pain with visual analog scale for pain
Secondary outcomes
1
Description
Illness Perception
Timepoint
Measurement of Illness Perception before the intervention, one month and three months after the intervention
Method of measurement
Illness Perception Questionnaire
Intervention groups
1
Description
Intervention group: Training based on Leventhal self-regulation model. Based on the Leventhal self-regulation model and based on the results obtained from subscales of questionnaires completed by girls, educational content will be provided. The number of sessions for the test group will be set at three sessions and each session lasts 60 to 90 minutes and for three consecutive weeks (one session per week) in groups of 8-10. In total, 12 groups (6 test and 6 control groups) will be formed and 18 training sessions will be held within 2 months at the school. Individual counseling sessions related to dysmenorrhea and common personal problems will be conducted as far as the researcher can. The first session: Based on the 5 dimensions of understanding the disease will be designed. The therapist will first assess the adolescent's understanding of the nature of menstrual distress. The study includes psychological symptoms related to menstrual distress such as anxiety, depression, and physical disorders such as fatigue, pain and weakness. It also examines adolescents' beliefs and hearings about the prevalence of menstrual distress and its complications (beliefs related to the identity of the disease). The next step in adolescents' understanding of the cause of the disease and one's beliefs about menstrual distress is to eliminate false beliefs (beliefs related to the cause of the disease). Then the duration of the illness and the adolescent's understanding of the duration of the illness will be examined (timetable). The next step deals with the distressing effects of menstruation on adolescent life (Consequences). Finally, the researcher examines the adolescent's perception of the efficacy of existing treatments to control and improve the severity of menstrual pain and relieve menstrual distress symptoms (treatment and improvement ideas). This session will use techniques of self-control, verbal encouragement, exercise-related stress reduction, feedback, and behavior assessment, use of successful illness experiences, and adolescents will be asked to practice these techniques. Pre-adolescent session tutorials will be asked to talk about their feelings and ambiguities about menstrual distress and their beliefs and knowledge will be challenged by the therapist. The training will be to change the misperceptions and the negative about the disease. They 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 and teens will be asked to practice these techniques. Third Session (Evaluation and Closing): Teens from the previous session will be notified of this closing session. Pre-session tutorials will be reviewed first, and then teens will be asked about the impact of new training and experiences. Problems and obstacles for each teenager will be explored, rehearsals of the previous session will be repeated, and their questions answered. Different methods will be used to increase the effectiveness of the training program. To achieve the content needed by adolescents in cognitive and psychological dimensions, a booklet will be used in addition to individual and face-to-face education. The content of this booklet is easy to understand for all teens. It is an attempt to increase understanding of the disease by providing simple illustrations with textual explanations. The educational content of this leaflet includes the identification and definition of menstrual distress, a brief explanation of misconceptions about menstrual cycles and activities authorized and unauthorized during this period, personal hygiene, physical activity and exercise, nutrition and stress control techniques and relaxation. will be. The qualitative content of this booklet will be reviewed by ten faculty members. At the end of three sessions, this leaflet will be given to the intervention group. In addition, if you have any further questions about the study or illness, the teen will be contacted
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
Shahid Bahonar Blvd. Ghazvin University of Medical Sciences
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. Mohammad Mahdi Imam jomea
Street address
Ghazvin, Shahid Bahonar Blvd. Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3335 7039
Fax
Email
research.dpt@qums.ac.ir
Web page address
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
Somayeh Asgari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Qazvin university of Medical Science, Bahonar blvd.
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 Asgari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Qazvin university of Medical Science, Bahonar blvd.
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
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Qazvin university of Medical Science, Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
s.asgari71@gmail.com
Web page address
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
En 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