Back to resultsEffects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Functional Exercises
Core Stability Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Core stability,Exercises,Primary dysmenorrhea,sleep quality
Eligibility Criteria
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.
Sites / Locations
- Jinnah HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Functional exercises
Core Stability Exercises
Arm Description
Piriformis stretching Cobra pose Sit up Bridging exercise
Pelvic bridging Plank Cat and camel Curl up
Outcomes
Primary Outcome Measures
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."
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05709951
First Posted
January 4, 2023
Last Updated
January 24, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05709951
Brief Title
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Official Title
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Core stability,Exercises,Primary dysmenorrhea,sleep quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Blinding
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional exercises
Arm Type
Active Comparator
Arm Description
Piriformis stretching Cobra pose Sit up Bridging exercise
Arm Title
Core Stability Exercises
Arm Type
Active Comparator
Arm Description
Pelvic bridging Plank Cat and camel Curl up
Intervention Type
Other
Intervention Name(s)
Functional Exercises
Other Intervention Name(s)
Exercises
Intervention Description
The patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks).
Intervention Type
Other
Intervention Name(s)
Core Stability Exercises
Other Intervention Name(s)
Exercises
Intervention Description
The patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks)
Primary Outcome Measure Information:
Title
Visual analogue scale for lower abdominal pain
Description
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."
Time Frame
8 week
Title
Menstrual Symptom Questionnaire
Description
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.
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index
Description
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).
Time Frame
8 week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female with primary dysmenorrhea
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Tariq, Phd
Phone
03344255033
Email
fatima.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Tariq, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Sarwer, PG
First Name & Middle Initial & Last Name & Degree
Hamid Sarwer, Masters*
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
We'll reach out to this number within 24 hrs