Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317532
• Other study ID #: P.T.REC/012/004766
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Manar E. Al-Emary, M.Sc. Stud
• Phone: +20 128 660 0931
• Email: manaralemary[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Description:

Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women. Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours. Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness. So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Their ages will be ranged from 18 to 25 years

2. They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.

3. Their BMI will be ranged from 20 to 25 kg/m2.

4. Having regular menstrual cycles (one every 28-34 days).

5. They will be sedentary virgin females.

6. They are non-smokers.

7. They have not been in any exercise program for three months.

Exclusion Criteria:

1. Having secondary dysmenorrhea.

2. Using regular medication or contraceptive pills.

3. Having neuromuscular, metabolic, or cardiac diseases.

4. Having a preexisting condition prevents them from engaging in an exercise program.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Lifestyle modification advice
All female participants in groups A and B will be provided with lifestyle modification advice, including recommendations such as reducing caffeine intake, limiting salt consumption, decreasing animal fat consumption, quitting smoking, practicing relaxation techniques, applying heat when needed, considering the use of herbal agents, avoiding cold drinks and foods, and opting for loose, cotton clothing.
• Functional exercises
Each female in group (B) will perform the exercise program three times a week for eight weeks at the University Women's Health Unit Exercise protocols mainly consist of relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga, and Pilates

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS)	It will be used to measure pain intensity for each female in both groups (A&B) before and after the end of treatment. The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable. " Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optional tool for describing pain intensity.	8 weeks
Primary	The Menstrual Distress Questionnaire	It will be used to evaluate menstruation symptoms and distress for each female in both groups (A&B) before and after the end of treatment. It consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5-point rating scale from 0-4. Each item has five options, i.e., No, mild, moderate, severe, and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven subscales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, and arousal control). The overall score was interpreted as follows: <50 - mild, 50 to 70 - moderate, and >70 severe.	8 weeks
Secondary	Quality of life enjoyment and satisfaction questionnaire	It will be used to assess health-related quality of life for participants of both groups (A&B) before and after the end of the treatment program. It consists of items that evaluate overall enjoyment and satisfaction regarding; Physical Health, mood, work, household and leisure activities, family and social relationships, ability to function in daily life, economic status, living or housing situation, ability to get around physically, ability to do work or hobbies, and overall sense of being. Responses will be scored on a five-point scale (from "very poor" to "very good"), where higher scores indicate better enjoyment and satisfaction with life. Scores will be added and presented as a percentage of the total maximum score. A percentage of the total score of > 70 represents the normal quality of life.	8 weeks
Secondary	Pressure pain threshold assessment	A pressure algometry will be used to measure pressure pain thresholds for all participants in both groups (A&B) before and after the end of the treatment program.	8 weeks