- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07634588
ACUTE EFFECT OF DIAPHRAGMATIC BREATHING ON POSTOPERATIVE UPPER TRAPEZIUS PAIN (TRAP-BREATHE)
EVALUATION OF THE ACUTE EFFECTS OF DIAPHRAGMATIC BREATHING EXERCISES ADDED TO SOFT TISSUE MOBILIZATION AND PERCUSSIVE THERAPY ON PAIN, FUNCTIONALITY, AND PRESSURE PAIN THRESHOLD IN THE UPPER TRAPEZIUS MUSCLE OF SURGICAL NURSES AFTER SURGERY
This randomized controlled trial aims to investigate the acute effects of diaphragmatic breathing exercises added to soft tissue mobilization and percussive therapy on pain intensity, functional disability, and pressure pain threshold in operating room nurses experiencing upper trapezius pain after surgery-related work activities.
Participants will be operating room nurses working in a hospital operating theater who report upper trapezius pain and tenderness within 30 minutes after completing a surgical procedure. Eligible participants will be randomly assigned to either an intervention group receiving soft tissue mobilization, percussive therapy, and diaphragmatic breathing exercises, or a control group receiving soft tissue mobilization and percussive therapy alone.
Pain intensity will be assessed using the Visual Analog Scale (VAS), functional disability using the Neck Disability Index (NDI), and mechanical pain sensitivity using Pressure Pain Threshold (PPT) measurements. Assessments will be performed immediately before and after a single treatment session. The study aims to determine whether the addition of diaphragmatic breathing exercises provides additional benefits in reducing pain and improving function in the acute postoperative working period of operating room nurses.
Přehled studie
Postavení
Detailní popis
Operating room nurses are exposed to prolonged static postures, repetitive upper extremity movements, and sustained neck and shoulder loading during surgical procedures. These occupational demands frequently result in upper trapezius pain, tenderness, and functional limitations. Acute musculoskeletal symptoms experienced after surgical procedures may negatively affect both occupational performance and quality of life.
Soft tissue mobilization and percussive therapy are commonly used physiotherapy interventions for reducing muscle tension, improving local circulation, and decreasing pain sensitivity. Diaphragmatic breathing exercises may further contribute to pain reduction through autonomic nervous system regulation, parasympathetic activation, and decreased physiological stress responses. Although each intervention has been investigated separately, evidence regarding their combined acute effects in operating room nurses is limited.
The purpose of this randomized controlled trial is to evaluate whether the addition of diaphragmatic breathing exercises to a treatment protocol consisting of soft tissue mobilization and percussive therapy provides additional benefits for pain reduction, functional improvement, and pressure pain threshold in operating room nurses experiencing upper trapezius pain following surgery-related work activities.
Participants meeting the eligibility criteria will be randomly allocated to one of two groups. The intervention group will receive soft tissue mobilization, percussive therapy, and diaphragmatic breathing exercises, while the control group will receive soft tissue mobilization and percussive therapy only. All interventions will be administered during a single treatment session under physiotherapist supervision.
Outcome measures will include pain intensity assessed by the Visual Analog Scale (VAS), functional disability assessed by the Neck Disability Index (NDI), and mechanical pain sensitivity assessed by Pressure Pain Threshold (PPT) measurements using a digital algometer. Measurements will be obtained immediately before and immediately after the intervention session.
The findings of this study may contribute to the development of practical physiotherapy strategies for managing acute work-related upper trapezius pain among operating room nurses and may help identify the additional value of diaphragmatic breathing exercises within a multimodal physiotherapy approach.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Fatma Çavdarcı
- Telefonní číslo: +905374590918
- E-mail: cvdrcftm@gmail.com
Studijní místa
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Eyalet/Yerleşke
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Istanbul, Eyalet/Yerleşke, Turecko (Türkiye), 34520
- Istanbul Aydin University
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Kontakt:
- FATMA ÇAVDARCI, PT, MSc
- Telefonní číslo: 05374590918
- E-mail: cvdrcftm@gmail.com
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged between 22 and 55 years.
- Operating room nurse actively working in the hospital operating theater.
- Reporting upper trapezius pain and tenderness within 30 minutes after completion of a surgical procedure.
- Willing to participate and able to provide written informed consent.
Exclusion Criteria:
- History of trauma, surgery, or chronic disease affecting the neck or shoulder region.
- Regular participation in breathing exercise programs.
- Psychiatric disorders requiring anxiolytic or antidepressant medication.
- Pregnancy.
- Skin disease, infection, or open wound in the treatment area.
- Severe cardiovascular disease or uncontrolled hypertension.
- Contraindications to manual therapy, soft tissue mobilization, percussive therapy, or breathing exercises.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Experimental Group
Participants will receive 5 minutes of soft tissue mobilization, 5 minutes of percussive therapy, and 5 minutes of diaphragmatic breathing exercises in a single treatment session.
|
Participants will perform diaphragmatic breathing exercises for 5 minutes in a seated position under physiotherapist supervision.
Soft tissue mobilization techniques will be applied to the upper trapezius muscle for 5 minutes.
Percussive therapy will be applied to the upper trapezius muscle for 5 minutes using a massage device.
|
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Aktivní komparátor: Control Group
Participants will receive 5 minutes of soft tissue mobilization and 5 minutes of percussive therapy in a single treatment session.
|
Soft tissue mobilization techniques will be applied to the upper trapezius muscle for 5 minutes.
Percussive therapy will be applied to the upper trapezius muscle for 5 minutes using a massage device.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: Immediately before intervention and immediately after intervention (single session)
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
The Visual Analog Scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain severity.
Change from pre-intervention to immediately post-intervention will be analyzed.
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Immediately before intervention and immediately after intervention (single session)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neck Disability Index
Časové okno: Immediately before intervention and immediately after intervention (single session)
|
Neck-related disability will be assessed using the Neck Disability Index (NDI).
The Neck Disability Index consists of 10 items with a total score ranging from 0 to 50 points.
A score of 0 indicates no disability and 50 indicates maximum disability.
Higher scores indicate greater disability and poorer neck function.
Change from pre-intervention to immediately post-intervention will be analyzed.
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Immediately before intervention and immediately after intervention (single session)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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