- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315050
Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents
Impact of Menstrual Health Education on Knowledge, Attitudes and Self Care Behavior of Female Adolescents With Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dysmenorrhea, characterized by painful cramps of the uterus during menstruation. It affects up to 95% of menstruating women. Dysmenorrhea is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea is defined as menstrual cramping pain that occurs immediately before or during menstruation in the absence of any pelvic pathology. The pain commonly starts within 3 years of menarche (the first menstrual period). Prevalence of primary dysmenorrhea varies from between 16 to 91% in reproductive aged women. Primary dysmenorrhea is the leading women hood problem that affects 90% of adolescent girls. Its prevalence decreases with increasing age in a large percentage of sufferers.
A study conducted in China concluded that nurse-managed education program improved adolescent girls' menstrual knowledge, promoted a more positive attitude, encouraged confidence, and improved pain relief practice. Another study conducted in Taiwan showed that the prevalence in dysmenorrhea in female adolescents was high, but they were lacking in dysmenorrhea related self-care knowledge. An Australian study concluded that the prevalence and impact of dysmenorrhea on Grade 11 and 12 girls is high, girls need more education on this area to prevent unnecessary suffering and interruption to school routine as they lack knowledge of and experience with effective treatment. A cross-sectional, internet-based survey was conducted, concluded that one in 3 women quit daily activities owing to menstrual symptoms. Half of all women did not mention menstrual complaints being the reason for transferring tasks in a family setting. However, considering the impact of menstrual symptoms on daily activities in a large group of women, it is time to open the societal dialogue and improve education for both patients and doctors.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hadia Nadeem, M.Phil PT
- Phone Number: 03351852442
- Email: hadia.nadeem@riphah.edu.pk
Study Locations
-
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Punjab
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Islamabad, Punjab, Pakistan, 44000
- Islamabad Model College for Girls
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Contact:
- Mahrukh Usmani, MSPT*
- Phone Number: +923367403964
- Email: mahrukh.usmani22@gmail.com
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Principal Investigator:
- Mahrukh Usmani, MSPT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescent girls aged 13-19 years of age.
- Experienced dysmenorrhea cramps 2 or more times during the last 6 months.
- Dysmenorrhea diagnosed using working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score.
Exclusion Criteria:
• Unwilling to participate.
- Known cases of depression, anxiety, bipolar disorder, and other mood disorder
- Minors whose parents do not allow.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Educational session and Informational Pamphlet
|
Each session will last for 50 minutes that will consist on lecturing, discussion about improving adolescent girls' menstrual knowledge, promoting a more positive attitude, encourage confidence, self-care behavior, physical activity and improve pain relief practice. Exercise advice: The exercise protocol will include aerobic exercise such as jogging, which perform in the interventional group, three times a week, and for 10 to 30 min. Stretching's advice: Piriformis stretching (5 repitition×20seconds), Cobra Pose. (5 repitition×20seconds), Adductor stretching. (5 repitition×20seconds), Sit up (10 repetition × 3 sets), Bridge exercise (10 repetition × 3 sets), Kegel exercise (10repetition × 3 sets), Pelvic eleva¬tion (10repetition × 3 sets), three times a week. |
|
ACTIVE_COMPARATOR: Informational Pamphlet
|
Pamphlets consist of information about primary dysmenorrhea its causes, symptoms (onset, duration, location, prognosis) and treatment strategies (taking hot bath, heating pad, yoga, exercise, maintaining hygiene, modifying life style) Emphasized on that menstruation is a not a disease it's a natural life experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstrual Attitude Questionnaire (MAQ)
Time Frame: 3 months
|
This scale was originally developed by Brooks-Gunn and Ruble and modified by Li.
It consists of 32 items with five dimensions, including menstruation as a debilitating event, menstruation as a bothersome event, menstruation as a natural event, anticipation and prediction of the onset of menstruation, and denial of any effect of menstruation.
Each item is scored on a 7-point Likert scale from 1 (disagree strongly) to 7 (agree strongly).
Total scores range from 32 to 224, with the higher score representing a more positive attitude toward menstruation.
|
3 months
|
|
Dysmenorrhoeic Knowledge Scale (DKS)
Time Frame: 3 months
|
The DKS was designed based on the researchers' clinical experiences and previous studies.
The scale included 20 questions with yes/no answers.
If the subject answered correctly, it was rated as 1; if answered incorrectly, it was rated as 0. Total scores ranged from 0 to 20 with the higher score representing a better knowledge of dysmenorrhea
|
3 months
|
|
Dysmenorrhoeic Self-Care behavior Scale (DSCBS)
Time Frame: 3 months
|
This scale was designed based on the researchers' clinical experiences and previous literature.
It contains 22 items.
Each item is scored on a 4-point Likert scale from 0 (never) to 3 (always).
Total scores ranged from 0 to 66, with the higher score representing a more positive self-care behavior.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mahrukh Usmani
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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