- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07628452
Comparative Effects of Aerobic Exercises and Jacobson's Progressive Relaxation Technique in Primary Dysmenorrhea
Comparative Effects of Aerobic Exercises and Jacobson's Progressive Relaxation Technique on Pain, Fatigue and Quality of Life in Primary Dysmenorrhea
The study will focus on the comparative effects of aerobic exercises and Jacobson's progressive relaxation technique on pain, fatigue and quality of life in primary dysmenorrhea.
This study will be a randomized clinical trial and will be conducted in, Superior college depalpur and Army public schools and college Lahore (APSACS). Non probability convenience sampling will be used to collect the data.64 participants will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by sealed opaque enveloped .Participants having age group between 17-24 years and diagnosed with WaLiDD score are included.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Primary dysmenorrhea (PD) refers to menstrual pain without organic lesions in the pelvic cavity , which mainly manifests as spastic pain and distension above the symphysis pubis in the lower abdomen before and after or during menstruation, radiating to the lumbosacral region and inner thigh. PD is a common gynecological disorder affecting 50%-90% of women. The study will focus on the comparative effects of aerobic exercises and Jacobson's progressive relaxation technique on pain, fatigue and quality of life in primary dysmenorrhea.
This study will be a randomized clinical trial and will be conducted in, Superior college depalpur and Army public schools and college Lahore (APSACS). Non probability convenience sampling will be used to collect the data.64 participants will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by sealed opaque enveloped .Participants having age group between 17-24 years and diagnosed with WaLiDD score are included. Athletes and married women will be excluded. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, EQ-5D-5L questionnaire for quality of life, fatigue assessment scale for fatigue. Both Groups will receive same baseline treatment which is core muscle strength. Group A will receive aerobic exercises and Group B will receive Jacobson's progressive relaxation technique for 3 times in a week. The treatment will be given for 8 weeks. Outcome measures will be measured at baseline and after 8 weeks. Data analysis will be done by SPSS version 25.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Imran Amjad, PhD
- Telefonní číslo: 03324390125
- E-mail: Imran.amjad@riphah.edu.pk
Studijní místa
-
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Punjab Province
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Okāra, Punjab Province, Pákistán, 52513
- Nábor
- Superior college for women and Polytechnic institute
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Vrchní vyšetřovatel:
- Aansa Manzoor, MSWHPT
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Pain on numeric rating pain scale,
- Menarche range 12-16,
- BMI less than 30,
- Having a regular menstrual cycle (28-32) days,
- Normal bleeding days (3 to 1) and diagnosed with mild PD according to WaLiDD score
Exclusion Criteria:
- Athletes,
- married women with gynaecological abnormalities were excluded,
- Medical treatment during the study (e.g., oral contraceptives, antidepressants)
- Recent musculoskeletal trauma or surgery, or chronic musculoskeletal disorders
- affecting pain perception (e.g., fibromyalgia, pelvic floor dysfunction)
- secondary dysmenorrhea-related conditions (e.g., endometriosis, fibroids, ovarian cysts),
- consumption of painkillers
- No mental or physical diseases, which reduce the abilities to exercise
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: aerobic exercises
Group A will receive aerobic exercises for 3 times in a week.
|
Group A Duration of forty five minutes Warm up exercises for 10 minutes. Free active movement of upper limb, lower limb, and upper body, cross toe to touch dynamic stretches such as lunges, Achilles tendon and hamstrings stretching. The aerobic workout duration will be 25mins.. The aerobic exercise involved the following steps with15reps of each exercise and while changing the step slow marching step for 15second and then move towards the next step. single step touch, double step touch, step touch front and back ,grapevine, knee lift , lunge side and back, L step ,V step, jumping jacks. Cool down exercises for 10 minutes included slow marching, quadriceps and hamstring and stretching. Subjects were prohibited from aerobics during menstruation and data were recorded for two menstrual cycles. |
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Experimentální: Jacobson's progressive relaxation technique
Group B will receive Jacobson's progressive relaxation technique for 3 times in a week.
|
Group B Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific muscle groups in a sequence that makes you feel calmer and makes you aware of your body and physical sensations.
It is also known as PMRT.
(39) JPRT was applied three times a week from the estimated date of ovulation to the onset of the next menstruation. .
The participants were in a supine position and were supported with cushions.
The JPRT involves participants actively contracting muscles to create tension and then progressively releasing them.
First of all, the participants were asked to contract the muscles tightly and hold for slow count of 5seconds (s) and then relax them completely for 10 s.
At the same time, the participants practiced diaphragmatic breathing.
The participants repeatedly performed JPMRT for each body part.
Each session lasted about 20-30 min.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
WaLlDD relaxation technique on pain, fatigue and quality of life in primary dysmenorrhea.
Časové okno: 2 months
|
At baseline, the participant scored at the initial level on the WaLliDD scale, indicating their starting status.
Over time, changes in the score reflect improvement or decline in the measured outcome.
An increase in score suggests positive progress in the targeted domain, while a decrease indicates reduced functioning or worsening condition compared to baseline.
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2 months
|
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Fatigue Assessment Scale
Časové okno: 2 months
|
At baseline, the participant's fatigue level is measured using the Fatigue Assessment Scale, providing a starting score of perceived fatigue.
Changes in the score over time indicate variation in fatigue severity.
A decrease from baseline reflects improvement (reduced fatigue), while an increase indicates worsening fatigue compared to the initial assessment.
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2 months
|
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EQ-5D-5-L-Questionnaire
Časové okno: 2 months
|
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life.
It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity.
It also includes a visual analog scale (VAS) where individuals rate their overall health.
Higher scores indicate better perceived health status.
|
2 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hafiza Iqra Rubab, MSWHPT, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- Gittens A, Griffiths-Bandoo S, Eccleston A, Irving SW, Dawkins JJJMCNS. How Does Primary Dysmenorrhea Impact the Quality of Life of Young Women Ages (18-35) in a Selected Community in St. James, Jamaica. 2025;3(2):1-4.
- Wu X, Yuan J, Ni J, Ma X, Zhang Z, Hua Y, et al. Electroacupuncture with different waveforms for primary dysmenorrhea: a randomized controlled trial. 2024;11(3):357-62.
- Esan DT, Ariyo SA, Akinlolu EF, Akingbade O, Olabisi OI, Olawade DB, et al. Prevalence of dysmenorrhea and its effect on the quality of life of female undergraduate students in Nigeria. 2024;5:100059.
- Dar M, Khan A, Shah SS, Aleem A, Jaber AAS, Hussain M, Khan GM. Evaluation of health-related quality of life of female students suffering from primary dysmenorrhea: findings of a cross-sectional study from Pakistan. Front Public Health. 2025 Apr 24;13:1467377. doi: 10.3389/fpubh.2025.1467377. eCollection 2025.
- Raule EB, Sapulete IM, Engka JNAJJII. Relationship Between Premenstrual Syndrome (Pms) And Appetite In Female Medical Students At Sam Ratulangi University. 2025;4(1):1071-9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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