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Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents

Primary Purpose

Primary Dysmenorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Educational session and Information Pamphlet
Information Pamphlet
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Dysmenorrhea, Menstruation, Adolescent, Knowledge, Attitude

Eligibility Criteria

13 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Islamabad Model College for Girls

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Educational session and Informational Pamphlet

Informational Pamphlet

Arm Description

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
March 30, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05315050
Brief Title
Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents
Official Title
Impact of Menstrual Health Education on Knowledge, Attitudes and Self Care Behavior of Female Adolescents With Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Dysmenorrhea, Menstruation, Adolescent, Knowledge, Attitude

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational session and Informational Pamphlet
Arm Type
Experimental
Arm Title
Informational Pamphlet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Educational session and Information Pamphlet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information Pamphlet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Menstrual Attitude Questionnaire (MAQ)
Description
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.
Time Frame
3 months
Title
Dysmenorrhoeic Knowledge Scale (DKS)
Description
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
Time Frame
3 months
Title
Dysmenorrhoeic Self-Care behavior Scale (DSCBS)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadia Nadeem, M.Phil PT
Phone
03351852442
Email
hadia.nadeem@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+923324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadia Nadeem, M.Phil PT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Islamabad Model College for Girls
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadia Nadeem, M. Phil
Phone
+923351852442
Email
hadia.nadeem@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mahrukh Usmani, MSPT*
Phone
+923367403964
Email
mahrukh.usmani22@gmail.com
First Name & Middle Initial & Last Name & Degree
Mahrukh Usmani, MSPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents

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