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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05315050
Other study ID # Mahrukh Usmani
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2022
Est. completion date November 2022

Study information

Verified date March 2022
Source Riphah International University
Contact Hadia Nadeem, M.Phil PT
Phone 03351852442
Email hadia.nadeem@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 138
Est. completion date November 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Educational session and Information 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.
Information 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.

Locations

Country Name City State
Pakistan Islamabad Model College for Girls Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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