NCT05315050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

DysmenorrheaMenstruationAdolescentKnowledgeAttitude

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    3 months

Study Arms (2)

Educational session and Informational Pamphlet

EXPERIMENTAL
Other: Educational session and Information Pamphlet

Informational Pamphlet

ACTIVE COMPARATOR
Other: Information Pamphlet

Interventions

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.

Educational session and 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.

Informational Pamphlet

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Unwilling to participate.
  • Known cases of depression, anxiety, bipolar disorder, and other mood disorder
  • Minors whose parents do not allow.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Model College for Girls

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

DysmenorrheaBehavior

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hadia Nadeem, M.Phil PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadia Nadeem, M.Phil PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations