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

NCT07586436 | Not Yet Recruiting

• 1 other identifier: HY-TDP-01
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Total Knee Arthroplasty; Pain After Knee Arthroscop; Total Knee Arthroplasty Recovery

Keywords

Total Knee Arthroplasty; pain; Vital Signs

Outcome Measures

Primary Outcomes (5)

• 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.

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

• Heart Rate

  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

  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

  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

  Respiratory rate (breaths per minute) will be recorded.

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

Study Arms (3)

Stress Ball Group

ACTIVE COMPARATOR

Patients use a stress ball during drain removal

Behavioral: 1. Stress Ball Intervention Description

Breathing Exercise Group

ACTIVE COMPARATOR

Patients perform breathing exercises during drain remo

Behavioral: 2. Breathing Exercise Intervention Description

Control Group

PLACEBO COMPARATOR

Patients receive standard care during drain removal.

Behavioral: 3. Control Group Description

Interventions

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.

Control Group

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.

Stress Ball Group

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.

Breathing Exercise Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Related Publications (4)

• 17. Ataman Yıldız G, Çınar F, Kadiroğulları E, Eti Aslan F. The effect of applications on pain after open and closed heart surgery: Descriptive research. Turkiye Klinikleri J Cardiovasc Sci. 2024;36(1):1-10.

  RESULT

• Bahar A, Yardimci I. Effect of breathing exercises applied before chest tube removal on pain and anxiety levels: descriptive and correlational research. Psychol Health Med. 2025 Dec;30(10):2388-2398. doi: 10.1080/13548506.2025.2519221. Epub 2025 Jun 25.

  PMID: 40560956 RESULT

• Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.

  PMID: 35397973 RESULT

• 1. Kuzuca BC, Güçlü B. Total diz artroplastisi öncesi planlama. TOTBİD Dergisi. 2021;20:507-514.

  RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

HÜMEYRA YÜKSEL, Ph.D

CONTACT

+905538748327; humeyragecici@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 14, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05