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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
3. Control Group Description
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
Trial outcomes
Primary outcomes
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.
Heart Rate
Heart rate (beats per minute) will be measured to assess physiological response to pain during drain removal.
Blood Pressure
Systolic and diastolic blood pressure (mmHg) will be measured to evaluate physiological stress response.
Oxygen Saturation
Peripheral oxygen saturation (%) will be measured using a pulse oximeter.
Locations
Sponsors and contacts
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