- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06339918
Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea
April 2, 2024 updated by: Riphah International University
Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique on Pain Intensity, Symptom Severity and Functional Activity in Primary Dysmenorrhea
A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants.
Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently.
Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique.
Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales.
Data will be analyzed using SPSS version 27.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized clinical trial.
Riphah International University QIE Campus in Lahore will serve as the site of data collecting and intervention services.
Non-probability convenience sampling will be the method of sampling.
The study's sample size will be 28 participants.
Inclusion criteria for this study will be: women between ages 14-26 years, nulliparous women, with a score greater than 4 in WALIDD primary dysmenorrhea intensity scales, history of normal menstrual cycles that lasts 3-7 days and ranged from 21- 35 days, ability to perform exercises independently.
Group A will be given kegel exercises as well as 4-7-8 breathing techniques for a total of 8 weeks with 4 sessions per week.
Whereas, group B will be given the 4-7-8 breathing technique only.
Initial assessment will be taken on the 3rd day of menstrual period.
Follow-up assessment will be taken after week 4 post interventions and final assessment will be done after week 8 post intervention.
WaLIDD primary dysmenorrhea intensity scale, Pain Self-Efficacy Questionnaire (PESQ), and Numeric Pain Rating Scale (NPRS) will be the data collecting instruments.
Study Type
Interventional
Enrollment (Estimated)
28
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
- Name: Ghulam Fatima, PhD*
- Phone Number: +923034073057
- Email: ghulam.fatima@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Riphah International University Clinic
-
Contact:
- Ghulam Fatima
- Phone Number: +923034073057
- Email: ghulam.fatima@riphah.edu.pk
-
-
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
Yes
Description
Inclusion Criteria:
- Nulliparous women
- Women with a score greater than 4 on WALIDD primary dysmenorrhea intensity scale
- Women having a history of normal menstrual cycles that lasts 3-7 days and range from 21- 35 days.
- Ability to perform exercises independently
Exclusion Criteria:
- Women with very mild primary dysmenorrhea
- Women treated for ovarian cysts or other gynecological issues
- Women currently taking medication for dysmenorrhea
- History of any systemic illness
- A history of psychological conditions that could influence the perception of pain and functional activity.
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: Kegel Exercise with4-7-8 Breathing technique group:
GroupAwill be given the intervention of kegel exercises as well as 4-7-8 breathing techniques for about 15 minutes per session for a total of 8 weeks with 4 sessions per week.
To perform kegel exercises, tighten pelvic floor muscles like trying to hold in urine and stool.
4-7-8 breathing Technique can be performed by telling the participant to inhale to the count of 4. Hold their breath for 7 counts.
To the count of 8, release air via their mouth.
|
Kegel exercises (also called pelvic floor exercises)will be used to strengthen the pelvic floor muscles it will involve repeatedly contracting and relaxing the muscles that form part of the pelvic floor.
This can be performed in the following way: Participants taking part should locate a comfy spot to sit.
Inhale to the count of 4. Hold their breath for 7 counts.
To the count of 8, release air via their mouth.
|
Active Comparator: 4-7-8 Breathing Technique group
In this group, we only perform the 4-7-8 Breathing Technique by telling the participant to inhale to the count of 4. Hold their breath for 7 counts.
To the count of 8, release air via their mouth.
|
This can be performed in the following way: Participants taking part should locate a comfy spot to sit.
Inhale to the count of 4. Hold their breath for 7 counts.
To the count of 8, release air via their mouth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: up to 8 weeks
|
TheNPRSisa popular patient-reported response scale is the NPRS.
The most widely used form of the NPRS is the ordinal 11-point version (0-no pain, 10-most extreme pain).
A line or bar that is horizontal is the standard format.
The NPRS is anchored by phrases that describe extremes of pain severity.
|
up to 8 weeks
|
WALIDD Primary Dysmenorrhea Intensity Scale
Time Frame: up to 8 weeks
|
WaLIDD stands for working ability, location, intensity, days of pain, dysmenorrhea.
It is used to diagnose Primary dysmenorrhea as well its pain intensity and severity of symptoms.
It is a new tool established and used in many researches and practices as a questionnaire to evaluate whether women are suffering from primary dysmenorrhea or not.
The WaLIDD instrument is part of a confidential questionnaire that inquires about every factor to be examined, as well as details about age, menarche, menstrual cycle features, type and number of nonsurgical treatments used to manage dysmenorrhea, number of days of medical leave taken for dysmenorrhea.
|
up to 8 weeks
|
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: up to 8 weeks
|
The Pain Self-Efficacy Questionnaire (PSEQ) is a valid instrument that is widely used to evaluate a person's comfort level with chronic pain management.
Rhe PSEQ measures self-efficacy beliefs in pain management and how important it is to comprehend how pain affects both functional and emotional elements of life.
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nirmal Zahid, MS*, Riphah International University, Lahore, Pakistan
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
- Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.
- Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302.
- Bakhsh H, Algenaimi E, Aldhuwayhi R, AboWadaan M. Prevalence of dysmenorrhea among reproductive age group in Saudi Women. BMC Womens Health. 2022 Mar 19;22(1):78. doi: 10.1186/s12905-022-01654-9.
- Matsas A, Sachinidis A, Lamprinou M, Stamoula E, Christopoulos P. Vitamin Effects in Primary Dysmenorrhea. Life (Basel). 2023 Jun 1;13(6):1308. doi: 10.3390/life13061308.
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)
April 1, 2024
Primary Completion (Estimated)
September 20, 2024
Study Completion (Estimated)
October 5, 2024
Study Registration Dates
First Submitted
March 25, 2024
First Submitted That Met QC Criteria
March 25, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0570
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
-
Cynthia del Rocío Márquez BeltránUniversity of HuelvaActive, not recruitingPrimary Dysmenorrhea | Menstrual Pain | Menstrual Distress \(Dysmenorrhea\)Spain
-
Hacettepe UniversityRecruitingPrimary DysmenorrheaTurkey
-
Tokat Gaziosmanpasa UniversityRecruitingDysmenorrhea | Dysmenorrhea PrimaryTurkey
-
Cairo UniversityNot yet recruitingPrimary Dysmenorrhea
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingPrimary Dysmenorrhea
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
University of ValenciaCompleted
-
University of SalamancaCompletedDysmenorrhea PrimarySpain
-
Riphah International UniversityCompleted