Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea

NCT06339918 | Completed

• 1 other identifier: REC/RCR & AHS/23/0570
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

Kegel Exercises; Breathing Exercises; Relaxation Techniques

Outcome Measures

Primary Outcomes (3)

• Numeric Pain Rating Scale

  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

  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)

  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

Study Arms (2)

Kegel Exercise with4-7-8 Breathing technique group:

EXPERIMENTAL

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.

Other: KegelExercise; Other: 4-7-8 breathing technique

4-7-8 Breathing Technique group

ACTIVE COMPARATOR

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.

Other: 4-7-8 breathing technique

Interventions

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.

Kegel Exercise with4-7-8 Breathing technique group:

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.

4-7-8 Breathing Technique group; Kegel Exercise with4-7-8 Breathing technique group:

Eligibility Criteria

• Age: 14 Years - 26 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University Clinic

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 32858887 BACKGROUND

• 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.

  PMID: 28944048 BACKGROUND

• 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.

  PMID: 35305636 BACKGROUND

• 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.

  PMID: 37374091 BACKGROUND

Study Officials

• Nirmal Zahid, MS*

  Riphah International University, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: September 20, 2024
• Study Completion: October 5, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)