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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06339918
• Other study ID #: REC/RCR & AHS/23/0570
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 5, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: ghulam Fatima, PhD*
• Phone: +923034073057
• Email: ghulam.fatima[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 5, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• KegelExercise
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
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.

Locations

Country	Name	City	State
Pakistan	Riphah International University Clinic	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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