Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in PD

June 11, 2024 updated by: Riphah International University

Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in Primary Dysmenorrhea

This project was a Randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from DHQ hospital Toba Tek were randomly assigned, baseline assessment was done, Group A paarticipants were given baseline treatment along with mojzisova method, Group B participants were given baseline treatment along with stretching exercises, post intervention assessment was done, via WALIDD, Numeric pain rating scale (NPRS) and Pittsburgh sleep quality index (PSQI) questionnaire 45 minutes per session, 2 sessions per month for 3 months, data was analyzed by using SPSS version 26.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary dysmenorrhea is most common reported problems to gynecologists and physical therapists. There is long history of using over the counter painkillers. Due to this there is high absenteeism from schools colleges and work. On the basis of symptoms primary dysmnorhea can be separated from secondary dysmenorrhea.Physical activity has long been used for relieving the pain, menstrual symptoms and improve insomnia. Previous studies also reported the effects of stretching exercises, core stabilizing exercises yoga, Pilates, aerobics on improving the pain and symptoms in primary dysmenorrhea. According to researcher knowledge there is limited evidence on mojzisova method that how this method improve the menstrual symptoms, pain and insomnia in primary dysmenorrhea. The aim of this study is to see the effects of mojzisova method on pain, menstrual symptom and insomnia in primary dysmenorrhea.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Toba Tek Singh, Punjab, Pakistan, 36050
        • DHQ Hospital
        • Contact:
        • Principal Investigator:
          • Zainab Waheed, MS-WHPT
        • Sub-Investigator:
          • H Neelam Muneeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pain must be recurrent (at least following three menstrual cycles).
  • No history of any blood problems, such as thalassemia, folate insufficiency, or anemia due to a lack of iron. Five criteria to fulfill to be considered primary dysmenorrhea.
  • Hypogastrium pain during menstruation.
  • Irradiation of pain to lower back, lower limbs or lingual region.
  • Inability to perform daily activity.
  • The need for medical management or self-medication to control pain Nulliparous women with primary dysmenorrhea.

Exclusion Criteria:

  • Female with history of any specific disease.
  • Female with endocrine disorders.
  • Had gone major surgery.
  • Diagnosis of secondary dysmenorrhea.
  • Having symptoms such as numbness and tingling sensation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mojzisova method
Mobilization of rib, lumbar spine, SI joint and internal rectal work. Stretching and strengthening exercises of pelvic floor, lumbar spine, sacrum and coccyx.
Other: Mojzisova method
The home based regular exercises stretching and strengthning exercises twice daily along with hot pack. Manual therapy was applied in the first half of the menstrual cycle, once a month, for one hour. It includes mobilization of ribs, lumbar spine, and sacroiliac joints as well as coccygeal treatment, and internal rectal work. The patient was received 2 sessions per month for 3 months, for 45 minutes.
Active Comparator: Stretching exercises
Stretching exercises cobra pose, child pose and cat/cow pose.
Other: Stretching exercises
Stretching exercises was performed such as cobra pose, cat/cow pose and baby pose along with hotpack for 2 sessions per month for 45 min for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WALIDD
Time Frame: 4th week
A scale-type survey (working ability, location, intensity, days of pain, dysmenorrhea [WaLIDD] score) was designed.)which integrated features of dysmenorrhea such as: 1) number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2) Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), 3) number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4) frequency of disabling pain to perform their activities (never, almost never, almost always, always).Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points.
4th week
NPRS
Time Frame: 4th week
The numeric rating scale is similar to the VAS in that it is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable" (or something similar). The difference is that instead of a line without marks, numbers from 0 to 10 are spaced evenly across the page. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. A variation of this scale is the verbal numeric scale (VNS), in which patients are asked to verbally state a number between 0 and 10 that corresponds to their present pain intensity.
4th week
PSQI Questionnaire
Time Frame: 4th week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score, which ranges from 0 to 21, is calculated by adding the component scores. Poorer sleep quality is indicated by higher scores.
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Syed Shakeel Ur Rehman, Phd, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0562 Zainab Waheed

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Dysmenorrhea

Clinical Trials on Mojzisova method

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe