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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06045169
Other study ID # FUI/CTR/2023/15
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date February 10, 2024

Study information

Verified date September 2023
Source Foundation University Islamabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be a quasi experimental study in which females aged 18 - 30 years with primary dysmenorrhea will be recruited in single group. They will be given a total of 3 sessions of treatment during a period of one menstrual cycle (One Week). Before and after the introduction of intervention pain and quality of life of participants will be assessed.


Description:

Primary Dysmenorrhea is one of the most prevalent gynecological conditions which impacts the quality of life of young females.Primary dysmenorrhea is defined as cramping like pain during menstruation cycle without the presence of any pelvic pathology it is associated with symptoms like headache,vomitting and irritability.The aim of our study is to determine the effects of muscle energy technique in young females with primary dysmenorrhea in terms of pain and quality of life.This study will be a Quasi Experimental study.It will be conducted at Foundation university college of physical therapy.Paticipants will complete WALIDD scale,NPRS and WHOQOL at baseline and then after intervention.All participants will receive post isometric relaxation of global muscles of core commonly involved in primary dysmenorrhea(Gluteus Maximus,Illiopsoas and Piriformis).Post isometric relaxation technique will be applied to all the participants with participants using 20% of their maximum voluntary contractio with held time of 6-10 seconds followed by 15 to 30 seconds stretch,rest time of 5 seconds between each repetitions and 3-5 repetions.There will be a total of 3 sessiond of treatment(1st on second day of menstruation,2nd on fourth day of menstruatio and 3rd on seventh day of menstruation)during a period of one week (one menstraul cycle).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date February 10, 2024
Est. primary completion date September 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Female aged 18 - 30 - Primary Dysmenorrhea - Unmarried Exclusion Criteria: - Not on any contraceptive medicine for treatment of pelvic pathology - Secondary Dysmenorrhea and other issues such as endometriosis, Pelvic inflammatory disease, Ovarian cyst

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Post Isometric Relaxation
Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain will be measured using numeric pain rating scale which is an 10 point scale scored from zero indicating no pain and 10 indicating worst pain. 1 week
Secondary Quality of life of participant Quality of life will be measured by WHOQOL-bref (World Health questionnaire for quality of life) which is valid and reliable tool for measuring quality of life with 26 instruments, Each individual item score from one to five on response scale. 1 week
Secondary WALIDD Working ability, Location, Intensity, Days of pain, Dysmenorrhea (WALIDD) is a scale with four categories Score of each category is added to find out the total level of severity of dysmenorrhea. 1 week
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