- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Fatma Çavdarcı
- Telefonnummer: +905374590918
- E-mail: cvdrcftm@gmail.com
Studiesteder
-
-
Eyalet/Yerleşke
-
Istanbul, Eyalet/Yerleşke, Tyrkiet (Türkiye), 34520
- Istanbul Aydin University
-
Kontakt:
- FATMA ÇAVDARCI, PT, MSc
- Telefonnummer: 05374590918
- E-mail: cvdrcftm@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 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.
|
Immediately before intervention and immediately after intervention (single session)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck Disability Index
Tidsramme: 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.
|
Immediately before intervention and immediately after intervention (single session)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TR-TRAP-2026-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nakke smerter
-
Insel Gruppe AG, University Hospital BernGaslini Children's HospitalTilmelding efter invitationAnæstesi | Trakeostomi komplikation | Emergency Front of Neck Airway hos børnSchweiz
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
-
University Children's Hospital, ZurichAfsluttetEmergency Front of Neck Airway hos børnSchweiz
-
Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
-
Beijing Sport UniversityIkke rekrutterer endnu
-
Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
-
Future University in EgyptAfsluttet
Kliniske forsøg med Diaphragmatic Breathing Exercise
-
Riphah International UniversityRekruttering
-
Baylor UniversityCongressionally Directed Medical Research ProgramsIkke rekrutterer endnuKroniske bækkensmerterForenede Stater
-
Riphah International UniversityAfsluttet
-
Riphah International UniversityRekruttering
-
Izmir Katip Celebi UniversityAfsluttetAkut respirationssvigtKalkun
-
Acibadem UniversityAfsluttetSmerte | Kvalme | Angst | Endoskopisk retrograd kolangiopankreatografiTyrkiet (Türkiye)
-
University of SalfordRekrutteringDysfunktionel vejrtrækning | ÅndedrætsmønsterforstyrrelseDet Forenede Kongerige
-
Mustafa Kemal UniversityAfsluttet
-
Ondokuz Mayıs UniversityIkke rekrutterer endnuBrystkirurgi | Brystkræft | Postoperativ smerte | Angst
-
Cairo UniversityAfsluttetSamtidig triggerfølsomhedsjustering og diafragmafacilitering ved fravænning fra mekanisk ventilationMekanisk ventilerede patienter | Akut respirationssvigtEgypten