Clinical trial NCT06738212: Comparative Effects of Aerobic and Aviva Exercises in Primary Dysmenorrhea
Official title: Comparative Effects of Aerobic and Aviva Exercises on Pain Quality of Life, Sleep and Daily Functioning in Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: Exercise
Quality of life
Sleep
Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises.
Primary purpose: TREATMENT

Brief summary: Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. Primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. However, it can affect the quality of life of women and cause inability to carry out daily functioning consequently, absence from school or workplace. Exercise is one of the non-conservative methods to reduce the severity of primary dysmenorrhea. The aim of this study is to compare the effects of aerobic and Aviva exercises on primary dysmenorrhea. This study emphasizes the importance of aerobic exercises and Aviva exercise to reduce the severity of primary Dysmenorrhea. This will help in patients over all recovery and will improve general well-being.

This will be a Randomized clinical trial conducted on 42 participants. The data will be collected from Sharif Medical Complex and Kasrat Gym Lake City by using non-probability convenience sampling technique. Patients with primary dysmenorrhea diagnosed with Walid score questionnaire of age 20-40 will be included. A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises. Participants will be assessed using the Mc Gill pain questionnaire for pain, women health initiative insomnia rating scale will be used for sleep, and brief pain inventory short form for daily functioning and Quality of life enjoyment and satisfaction questionnaire short form for quality of life. Data will be analyzed by using SPSS version 26.0.


Eligibility criteria: Inclusion Criteria:

* Unmarried females
* Regular menstrual cycles (every 21-35 days)
* Moderate to severe menstrual cramp pain

Exclusion Criteria:

* Pelvic pathology (endometriosis, chronic pelvic inflammatory disease, adenomyosis)
* History of pelvic surgery or inflammatory disease
* Chronic pain or pain disorders (e.g., fibromyalgia)
* Current use of pain medication or muscle relaxants
* History of mental health disorders (e.g., depression, anxiety)
* Inability to understand or complete study assessments
* Any underlying medical condition that may be contributing to dysmenorrhea (e.g., thyroid disorders, kidney disease)

Primary outcomes:
measure: Mc Gill Pain Questionnaire
timeFrame: 12 weeks
measure: Women's Health Initiative Insomnia Rating Scale (WHIIRS)
timeFrame: 12 weeks
measure: Brief Pain Inventory Short Form SF 12
timeFrame: 12 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form(Q-LES-Q-SF)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sharif Medical Complex & Kasrat gym
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anis T, Hasan S, Lohana N, Salahuddin I, Saeed HJJoXaSU, Natural Sciences Edition. Effects of aerobic program on the severity of dysmenorrhea using WaLIDD score. 2023;19(6):550-4
citation: Kovacs Z, Atombosiye E, Hegyi G, Szoke H. The Effect of Aviva Exercise Intervention on Pain Level and Body Awareness in Women with Primary Dysmenorrhea. Medicina (Kaunas). 2024 Jan 20;60(1):184. doi: 10.3390/medicina60010184.
citation: Elbandrawy AM, Elhakk SM. Comparison between the effects of aerobic and isometric exercises on primary dysmenorrhea. 2021
citation: Gohil K, Mehta B. Effect of aerobic exercise on pain and quality of life in women with primary dysmenorrhea. International Journal of Applied Research. 2022;8(6):256-8
citation: Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.