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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06339918
Other study ID # REC/RCR & AHS/23/0570
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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