NCT05811455

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2023

Last Update Submit

April 12, 2023

Conditions

Pain SyndromeAnxiety

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • • 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

Study Arms (3)

Group A: aerobic exercises.

EXPERIMENTAL

The first treatment group will be given aerobic exercises for six weeks at least three times per week. This group will include 14 participants. This study group will be assigned with basic treatment protocol with aerobic exercises along with 10 minutes of warm up period.

Other: Aerobic exercises

group b progressive muscle relaxation exercises.

ACTIVE COMPARATOR

The intervention will be given three days per week for six weeks. Pre and post-treatment readings will be noted. Each total session will last for 45 minutes. The importance of the study will be explained, and consent will be taken from the people before the intervention will be applied. * Breathe in, and tense the first muscle group (hard but not to the point of pain or cramping) for 4 to 10 seconds. * Breathe out, and suddenly and completely relax the muscle group (do not relax it gradually) (20)

Other: Progressive muscle relaxation

Group C. Control group

NO INTERVENTION

No intervention was given

Interventions

Aerobic exercisesOTHER

To compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome

Group A: aerobic exercises.
Progressive muscle relaxationOTHER

progressive muscle relaxation exercises.

group b progressive muscle relaxation exercises.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar Institute of Professional Studies

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Somatoform DisordersAnxiety Disorders

Interventions

ExerciseAutogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fatima Tariq, Mphill

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

November 2, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)