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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorTC Erciyes University

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3. Control Group Description

    Behavioral

    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.

  • 1. Stress Ball Intervention Description

    Behavioral

    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.

  • 2. Breathing Exercise Intervention Description

    Behavioral

    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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Stress Ball GroupActive comparator 1 intervention
Group B: Breathing Exercise GroupActive comparator 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity (Numeric Rating Scale, NRS

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.

Time frame
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
2

Heart Rate

Heart rate (beats per minute) will be measured to assess physiological response to pain during drain removal.

Time frame
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
3

Blood Pressure

Systolic and diastolic blood pressure (mmHg) will be measured to evaluate physiological stress response.

Time frame
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
4

Oxygen Saturation

Peripheral oxygen saturation (%) will be measured using a pulse oximeter.

Time frame
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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