Total Knee ArthroplastyTDPNCT07586436
Effects of Stress Ball Use and Breathing Exercises on Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty
A study testing 1. Stress Ball Intervention Description and 2. Breathing Exercise Intervention Description in people with Total Knee Arthroplasty and Total Knee Arthroplasty Recovery, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Arthroplasty Recovery, Pain After Knee Arthroscop
- What is being tested?
- 1. Stress Ball Intervention Description and 2. Breathing Exercise Intervention Description
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- 3. Control Group Description, 1. Stress Ball Intervention Description, 2. Breathing Exercise Intervention Description
- Keywords
- Total Knee Arthroplasty, pain, Vital Signs
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3. Control Group DescriptionBehavioural
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 DescriptionBehavioural
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 DescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Active comparator | Patients use a stress ball during drain removal Receives: Behavioral: 1. Stress Ball Intervention Description |
| Breathing Exercise Group | Active comparator | Patients perform breathing exercises during drain remo Receives: Behavioral: 2. Breathing Exercise Intervention Description |
| Control Group | Placebo comparator | Patients receive standard care during drain removal. Receives: Behavioral: 3. Control Group Description |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Respiratory Rate
Respiratory rate (breaths per minute) will be recorded.
Measured: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start5 May 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜMEYRA YÜKSEL, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586436
- Sponsor's protocol ID
- HY-TDP-01
- Acronym
- TDP
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 40560956Genc 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.
PubMed 353979731. Kuzuca BC, Güçlü B. Total diz artroplastisi öncesi planlama. TOTBİD Dergisi. 2021;20:507-514.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07586436
- Acronym / sponsor ID
- TDP / HY-TDP-01
- Keywords
- Total Knee Arthroplasty, pain, Vital Signs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Active comparator | Behavioral: 1. Stress Ball Intervention DescriptionPatients use a stress ball during drain removal |
| Breathing Exercise Group | Active comparator | Behavioral: 2. Breathing Exercise Intervention DescriptionPatients perform breathing exercises during drain remo |
| Control Group | Placebo comparator | Behavioral: 3. Control Group DescriptionPatients receive standard care during drain removal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3. Control Group DescriptionParticipants will receive standard care, including routine information about the drain removal procedure, without any additional intervention such as stress ball use or breathing exercises. | Behavioural | Control Group |
| 1. Stress Ball Intervention DescriptionParticipants 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. | Behavioural | Stress Ball Group |
| 2. Breathing Exercise Intervention DescriptionParticipants 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. | Behavioural | Breathing Exercise Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication17. 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.
- Results publication: PubMed 40560956Bahar 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.
- Results publication: PubMed 35397973Genc 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.
- Results publication1. Kuzuca BC, Güçlü B. Total diz artroplastisi öncesi planlama. TOTBİD Dergisi. 2021;20:507-514.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Stress Ball Intervention Description and 2. Breathing Exercise Intervention Description in people with Total Knee Arthroplasty and Total Knee Arthroplasty Recovery, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HÜMEYRA YÜKSEL, Ph.D (+905538748327, humeyragecici@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Rating Scale, NRS (time frame: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07586436, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.