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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05811455
Other study ID # REC/RCR & AHS/22/054
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2022
Est. completion date January 30, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.


Description:

Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from this condition. This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important. Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies. However, these two interventions have never been compared to test their effects on pain, and functional performance.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Age between 18 to 40 years - Females in their last week of the luteal phase (1 week before menstruation) - Females with regular menstrual with equal intervals between 21 and 35 days - Females with a score of 133 and above after being screened with Premenstrual syndrome scale - Females suffering from PMS for at least the past six months Exclusion Criteria: - Females with the irregular menstrual cycle - Pregnant females - Menstruating females or females in the follicular or ovulatory phase - History of physical exercise in the past three months before the beginning of the study - Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercises
To compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome
Progressive muscle relaxation
progressive muscle relaxation exercises.

Locations

Country Name City State
Pakistan Johar Institute of Professional Studies Lahore 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 1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.(16) 6 weeks
Primary Numerical rating scales (NRSs) Numerical rating scales (NRSs) are the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable 6 weeks
Primary • SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36) The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) 6 weeks
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