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NCT Number: NCT07586436

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

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

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Key information

Conditions

Total Knee Arthroplasty Neurologic Manifestations Pain Pain After Knee Arthroscop Pathological Conditions, Signs and Symptoms Signs and Symptoms Total Knee Arthroplasty Recovery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity (Numeric Rating Scale, NRS

    Time frame: 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.

  2. Heart Rate

    Time frame: 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.

  3. Blood Pressure

    Time frame: 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.

  4. Oxygen Saturation

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

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

  5. Respiratory Rate

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

    Respiratory rate (breaths per minute) will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

HÜMEYRA YÜKSEL, Ph.D

CONTACT

[email protected]

+905538748327

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Acronym: TDP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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