Skip to main content
OpenTrials
Completed

NCT Number: NCT06339918

Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Dysmenorrhea

Age range

14 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University Clinic

Lahore, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KegelExercise

Other

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.

4-7-8 Breathing Technique

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique on Pain Intensity, Symptom Severity and Functional Activity in Primary Dysmenorrhea

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.