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

May 8, 2026 updated by: 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stress Ball Group
Patients use a stress ball during drain removal
Behavioral: 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.
Active Comparator: Breathing Exercise Group
Patients perform breathing exercises during drain remo
Behavioral: 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 Comparator: Control Group
Patients receive standard care during drain removal.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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.
Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HY-TDP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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