Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000605392
Ethics application status
Not required
Date submitted
31/10/2016
Date registered
27/04/2017
Date last updated
27/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of health education on menstrual pain among Arabic school girls in Malaysia.
Scientific title
The effect of health education on primary dysmenorrhea among Arabic school girls in Malaysia.
Secondary ID [1] 290415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhea 300756 0
Condition category
Condition code
Public Health 300590 300590 0 0
Health promotion/education
Reproductive Health and Childbirth 300591 300591 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Health Education planning and developed by the researcher which uses review of literates and expert panel evaluation. The technique will be used to deliver the health education is a lecture about primary dysmenorrhea, PowerPoint and pamphlet
The educational media will be used pamphlet which developed by the researcher which uses review of literates and expert panel evaluation. The aim of the pamphlet is to help participation to retain their knowledge and self-care on primary dysmenorrhea.
The duration of the entire session take 80 minutes.


Pre-test questionnaire
After the survey, researcher will be starting the pre-test questionnaire to assess student’s knowledge, self-care levels and quality of life before implementation of the health education, which researcher will be select the students who have primary dysmenorrhea according to inclusion Criteria through codes, researcher will collect them.

Researcher will distribute and read the questionnaire on students and the researcher will ask the students to answer a questionnaire with explaining any unclear questions by the researcher. When the students finish from answering the questionnaire, researcher will collect the questionnaires in boxes. The duration of pre-test about 15 minutes.

Health education intervention
In this phase, one day activity will be held by the researcher to introduce health educational intervention involving lecture and PowerPoint about primary dysmenorrhea. This workshop will be attended by primary dysmenorrhea students who have agreed to participate in the intervention group to improve knowledge, self-care, and quality of life.

The implementation of health education intervention is as follows:
1. The researcher will give presenting a lecture during a period of 30 minutes and PowerPoint about primary dysmenorrhea which including Information and advises about primary dysmenorrhea and associates symptoms related it as printed in pamphlet in colorful and attractions way.
2. Activities include discussion and quiz ( questions and answers) about primary dysmenorrhea information .
3. The researcher will distribute the pamphlets to all participation to take it and keep it as references for them.
4. The researcher will thank the participation and encourage them to communicate with the researcher to complete the collection of data after intervention (post-test questionnaire).

The pamphlet includes information with pictures about:
1) Menstruation and menstrual cycle, examples definitions of menstruation and menarche, the length of the period and duration with the defining of girls to the internal organs of girl reproductive system related the menstruation and how the menstrual cycle occurring simply with illustrations.
2) Information about dysmenorrhea, examples the definition the menstrual pain, types, causes, risk factors and symptoms of menstrual pain, also including information about how to identify the degree of pain through the using assessment pain tool. In addition to it contains the symptoms and the situations which the adolescent girls must seek help from a doctor or nurse.
3) The methods of self-care during menstrual pain by use pharmacological or non-pharmacological methods to allow girls to choose the most suitable for her condition. For details.

The information sources of educational media:
The sources information of pamphlet are from some articles such as (Chiou M. H. et al., 2007), (Wu et al., 2009), (Premila et al., 2015) and (Kanika, 2015). Also some resources from the scientific web site such as:
1) http://www.womenshealth.gov/publications/our-publications/fact sheet/menstruation.html#a,
2) http://www.medicinenet.com/menstruation/article.htm,
3) http://www.irise.org.uk/uploads/4/1/2/1/41215619/menstrual_health_education_resource.pdf and
4) Primary Dysmenorrhea American Family Physician; http://www.aafp.org/afp/1999/0801/p489.html


Post-test health education questionnaire
Then in thired month from follow up two months, I will communicate with the school again to distributing the same questionnaires to participants who I applied the intervention on them to assess the impact of health education.
The goal of the post-test twice is to give the opportunity to the application of knowledge and suitable self-care to improve quality of life through primary dysmenorrhea period.
Intervention code [1] 296249 0
Lifestyle
Intervention code [2] 297539 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300010 0
To determine the level of knowledge about primary dysmenorrhea among the schoolgirls by using knowledge questionnaire which designed for this study pre and post health education.
Timepoint [1] 300010 0
Baseline before intervention, then 12 weeks post intervention completion.
Primary outcome [2] 301752 0
To determine the level of self-care about primary dysmenorrhea among the schoolgirls by using self-care questionnaire which designed for this study pre and post health education..
Timepoint [2] 301752 0
Baseline before intervention, then 12 weeks post intervention completion.
Primary outcome [3] 301753 0
To determine the level of quality of life during primary dysmenorrhea among the schoolgirls by using Quality of Life questionnaire which designed for this study pre and post health education..
Timepoint [3] 301753 0
Baseline before intervention, then 12 weeks post intervention completion.
Secondary outcome [1] 328799 0
To determine the proportion of primary dysmenorrhea among the Arabian schoolgirls by using survey pre intervention were included in the questionnaire which designed for this study.
Timepoint [1] 328799 0
Baseline before intervention,
Secondary outcome [2] 331087 0
To explore the influences of culture beliefs on primary dysmenorrhea by using focus group interview.
Timepoint [2] 331087 0
12 weeks post intervention completion.

Eligibility
Key inclusion criteria
Girls between 13- 18 years old in Arabic schools in Malaysia.
Girls with menstrual pain score 3 and above.
Arabic girls.
Minimum age
13 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Girls between less than 13 years old or more than 18 years old in Arabic schools in Malaysia.
- Girls with menstrual pain score less than 3.
- Non Arabic girls.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 8358 0
Malaysia
State/province [1] 8358 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 294822 0
University
Name [1] 294822 0
University of Malaya
Country [1] 294822 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
Nursing Science Department
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 293667 0
Individual
Name [1] 293667 0
Latifa Yahya Alajeel
Address [1] 293667 0
Nursing Science Department
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country [1] 293667 0
Malaysia

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Many girls perceive menstruation as time to celebrate the transition from girlhood to womanhood however, a significant proportion of girls suffer from dysmenorrhea.

Primary dysmenorrhea is a cramping pain in the lower abdomen that occur before or during menstruation without identifiable pelvic pathology (Kannan & Claydon, 2014). It's affecting from 50% to 91% of women of reproductive age in worldwide (Mahvash et al., 2012), its prevalence increases through the adolescent years and decreases with increases in age (Dawood, 2006).
The prevalence of Primary dysmenorrhea in the Arab countries are high, for example about 94% in Egypt (Maher, Eman, & Ahmed, 2011), 74.3% in Lebanon(Santina, Wehbe, & Ziade, 2012), 94% in Oman (Al-Kindi & Al-Bulushi, 2011), 72.4% in Yemen (Hearst & Molnar, 2013) and 55.8% in Jordanian(Al-Jefout et al., 2014).

The aim of this study will aim to assess the impact of health education on primary dysmenorrhea among Arabic school girls.
This study will apply both quantitative and qualitative study design (Grove, Burns, & Gray, 2013)and also develop and evaluate the intervention conducted.

The quantitative research design used in this study is a quasi-experimental design with single group design which involves both pre and posttest will be applied in this study to determine whether health education improves the knowledge, self-care and quality of life among schoolgirls with primary dysmenorrhea.
Following quantitative approach, a qualitative study will be conducted to explore the influences of culture beliefs on primary dysmenorrhea. Exploring lived perceptions would give meaning to each person’s perceptions of a particular phenomenon under study.

The outcome of the study will be expected to improve knowledge ,self-care and quality of life. and the finding of the focus group discussions will be supporting the self-care outcome in term of influences of Arabic culture.
Trial website
Trial related presentations / publications
Public notes
Because the study will not including patient or intended to use any medical intervention it just need approval from schools administrations and parents.

Contacts
Principal investigator
Name 55922 0
Mrs LATIFA YAHYA AHMED ALAJEEL
Address 55922 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 55922 0
Malaysia
Phone 55922 0
+601139009597
Fax 55922 0
Email 55922 0
[email protected]
Contact person for public queries
Name 55923 0
Mr Abdulaziz Mansoor Alraimi
Address 55923 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 55923 0
Malaysia
Phone 55923 0
+60182127207
Fax 55923 0
Email 55923 0
[email protected]
Contact person for scientific queries
Name 55924 0
Dr Chong Mei Chan
Address 55924 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 55924 0
Malaysia
Phone 55924 0
+603-79493675
Fax 55924 0
Email 55924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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