Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea

To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.

Study Overview

• Status: Recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Functional Exercises; Other: Core Stability Exercises

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatima Tariq, Phd; Phone Number: 03344255033; Email: fatima.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Jinnah Hospital
      • Contact: Hamid Sarwer, PG
      • Principal Investigator: Hamid Sarwer, Masters*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
• Pain must be periodic (at least following 3 menstrual cycles).
• Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
• No history of blood disorders including thalassemia and folate or iron-deficiency anemia

Exclusion Criteria:

• Pelvic inflammatory disease
• Ovarian cysts
• Chronic abdominal pain
• Fibroids, obstructive endometrial polyps,
• Irritable bowel syndrome
• Major abdominal or pelvic surgery
• Intrauterine devices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Functional exercises; Piriformis stretching Cobra pose Sit up Bridging exercise	Other: Functional Exercises; The patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks).; Other Names: Exercises
ACTIVE_COMPARATOR: Core Stability Exercises; Pelvic bridging Plank Cat and camel Curl up	Other: Core Stability Exercises; The patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks); Other Names: Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale for lower abdominal pain	The subjective and verified visual analogue scale is used to quantify both acute and chronic pain (1). On the 10 cm line, scores are recorded by making a mark. Pain intensity is measured along a 10-cm line with 0 denoting "no pain" and 10 denoting "worst pain."	8 week
Menstrual Symptom Questionnaire	Menstrual Symptom Questionnaire (MSQ) to assess dysmenorrhea symptoms. The MSQ is a 24 item self-report measure which assesses menstrual pain and symptoms (e.g. 'I have cramps that begin on the first day of my period'; 'I feel depressed for several days before my period'). The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.	8 weeks
Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) evaluates sleep disruptions and quality over a 1-month period. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).	8 week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Fatima Tariq, PhD, Riphah International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Core stability,Exercises,Primary dysmenorrhea,sleep quality
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: RiphahIU fatimatariq1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No