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Effects of Stress Ball Use and Breathing Exercises on Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty (TDP)

8. maj 2026 opdateret af: HÜMEYRA YÜKSEL, TC Erciyes University

The Effect of Stress Ball Use and Breathing Exercises on Procedural Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effects of stress ball use and breathing exercises on procedural pain and vital signs during drain removal in patients undergoing total knee arthroplasty. Although drain removal is a short procedure, it is often associated with sudden and intense pain and may trigger physiological stress responses such as increased heart rate, blood pressure, and respiratory rate.

A total of 105 patients will be randomly assigned to three groups: stress ball group, breathing exercise group, and standard care group. The interventions will be applied starting one minute before drain removal, continuing throughout the procedure, and for two minutes afterward.

Pain levels will be assessed using the Numeric Rating Scale (NRS), and vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be measured at predefined time points before, during, and after the procedure. The findings of this study are expected to provide evidence on the effectiveness of simple, non-pharmacological interventions in reducing procedural pain and improving physiological stability during drain removal

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

105

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years and older undergoing primary total knee arthroplasty
  • Patients with a surgical drain in place and scheduled for drain removal in the postoperative period
  • Able to provide informed consent
  • Able to communicate and understand instructions

Exclusion Criteria:

  • Patients with chronic pain syndromes or regular opioid use
  • Patients with cognitive impairment, delirium, or communication difficulties
  • Patients with contraindications to drain removal (e.g., active bleeding, hemodynamic instability)
  • Patients with neurological conditions affecting pain perception

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Stress Ball Group
Patients use a stress ball during drain removal
Adfærdsmæssigt: 1. Stress Ball Intervention Description
Participants will be provided with a medium-resistance stress ball and instructed to rhythmically squeeze and release it starting one minute before drain removal, continuing throughout the procedure, and for two minutes after the procedure. A brief explanation will be given prior to the intervention.
Aktiv komparator: Breathing Exercise Group
Patients perform breathing exercises during drain remo
Adfærdsmæssigt: 2. Breathing Exercise Intervention Description
Participants will be instructed in diaphragmatic breathing techniques before the procedure. They will begin deep breathing one minute before drain removal, continue throughout the procedure, and for two minutes afterward. The technique includes slow inhalation through the nose, holding the breath for a few seconds, and slow exhalation through the mouth.
Placebo komparator: Control Group
Patients receive standard care during drain removal.
Adfærdsmæssigt: 3. Control Group Description
Participants will receive standard care, including routine information about the drain removal procedure, without any additional intervention such as stress ball use or breathing exercises.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity (Numeric Rating Scale, NRS
Tidsramme: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst possible pain. Pain levels will be recorded during and after drain removal.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Heart Rate
Tidsramme: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Heart rate (beats per minute) will be measured to assess physiological response to pain during drain removal.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Blood Pressure
Tidsramme: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Systolic and diastolic blood pressure (mmHg) will be measured to evaluate physiological stress response.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Oxygen Saturation
Tidsramme: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Peripheral oxygen saturation (%) will be measured using a pulse oximeter.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Respiratory Rate
Tidsramme: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Respiratory rate (breaths per minute) will be recorded.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TC Erciyes University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. maj 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. august 2026

Datoer for studieregistrering

Først indsendt

3. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HY-TDP-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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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 Total knæarthroplastik

Kliniske forsøg med 1. Stress Ball Intervention Description

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