Primary DysmenorrheaNCT05315050
Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents
A study testing Educational session and Information Pamphlet and Information Pamphlet in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Educational session and Information Pamphlet and Information Pamphlet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- • Unwilling to participate.
- Known cases of depression, anxiety, bipolar disorder, and other mood disorder
- Minors whose parents do not allow.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamabad Model College for Girls
Islamabad, Punjab Province, 44000
Hadia Nadeem, M. Phil, +923351852442, hadia.nadeem@riphah.edu.pk
Mahrukh Usmani, MSPT*, +923367403964, mahrukh.usmani22@gmail.com
About this study
Official title: Impact of Menstrual Health Education on Knowledge, Attitudes and Self Care Behavior of Female Adolescents With Primary Dysmenorrhea
This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Group A will receive Educational sessions and informational pamphlet while Group B will only receive the pamphlets. Experimental group will receive for 4 sessions (2 per week). The outcome measures Menstrual Attitude Questionnaire (MAQ), Dysmenorrhoeic Knowledge Scale (DKS) and Dysmenorrhoeic Self-Care behavior Scale (DSCBS) will be measured at baseline, and at the end of week 2 and after 3 months. Data will be analyzed by SPSS 21.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Educational session and Information Pamphlet, Information Pamphlet
- Keywords
- Dysmenorrhea, Menstruation, Adolescent, Knowledge, Attitude
- Medical subject headings
- Dysmenorrhea, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational session and Information PamphletOther
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.
Information PamphletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational session and Informational Pamphlet | Experimental | Not described Receives: Other: Educational session and Information Pamphlet |
| Informational Pamphlet | Active comparator | Not described Receives: Other: Information Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Attitude Questionnaire (MAQ)
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.
Measured: 3 months
Dysmenorrhoeic Knowledge Scale (DKS)
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
Measured: 3 months
Dysmenorrhoeic Self-Care behavior Scale (DSCBS)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadia Nadeem, M.Phil PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315050
- Sponsor's protocol ID
- Mahrukh Usmani
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Menstrual Health Education on Knowledge, Attitudes and Self Care Behavior of Female Adolescents With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05315050
- Acronym / sponsor ID
- Mahrukh Usmani
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Menstruation, Adolescent, Knowledge, Attitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Group A will receive Educational sessions and informational pamphlet while Group B will only receive the pamphlets. Experimental group will receive for 4 sessions (2 per week). The outcome measures Menstrual Attitude Questionnaire (MAQ), Dysmenorrhoeic Knowledge Scale (DKS) and Dysmenorrhoeic Self-Care behavior Scale (DSCBS) will be measured at baseline, and at the end of week 2 and after 3 months. Data will be analyzed by SPSS 21.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational session and Informational Pamphlet | Experimental | Other: Educational session and Information Pamphlet |
| Informational Pamphlet | Active comparator | Other: Information Pamphlet |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- • Unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational session and Information PamphletEach 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. | Other | Educational session and Informational Pamphlet |
| Information PamphletPamphlets 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. | Other | Informational Pamphlet |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadia Nadeem, M.Phil PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational session and Information Pamphlet and Information Pamphlet in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadia Nadeem, M.Phil PT (03351852442, hadia.nadeem@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Attitude Questionnaire (MAQ) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.