PainStress ballNCT07251270
Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery
A study testing Stress ball in people with Pain and Hemodynamic Changes, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Hemodynamic Changes, Anxiety
- What is being tested?
- Stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Patients will be included : have only one chest tube after open heart surgery,
- are 18 years of age or older,
- are conscious and cooperative,
- speak and understand Turkish,
- have a stable general condition and hemodynamic variables,
- have a planned surgical procedure,
- have no previous chest tube experience,
- have no psychiatric diagnosis,
- are not using psychiatric and/or local neuromuscular blocking medications,
- agree to participate in the study (sign the Informed Consent Form).
Exclusion Criteria:Patients who do not have a chest tube or have multiple chest tubes after open heart surgery,
- Are under 18 years of age,
- Are conscious and uncooperative,
- Do not speak or understand Turkish,
- Are in an unstable general condition or hemodynamic variables,
- Have undergone emergency surgery,
- Have previous chest tube placement experience,
- Have a current psychiatric diagnosis,
- Are taking psychiatric and/or local neuromuscular blocking medications,
- Do not agree to participate in the study (do not sign the Informed Consent Form) will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University,
Yenişehir, Mersin, 33120
About this study
Official title: Effect of Stress Ball on Pain, Anxiety Levels, and Hemodynamic Variables During Chest Tube Removal After Open Heart Surgery
15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.
The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.
Read the detailed description
Chest tubes are routinely removed on the second or third postoperative day in patients in the Cardiovascular Surgery Intensive Care Unit, and patients with stable hemodynamic variables are discharged to the clinic. Morphine (0.01 mg) and paracetamol (if necessary) are used for routine analgesic treatment during the intensive care unit. Data will be collected between September 1, 2025, and September 1, 2026. Before the stress ball application after open heart surgery, participants in the control and study groups will be asked to complete the Descriptive Characteristics Form, VAS, VAS-A, and Hemodynamic Variables Monitoring Form. The Hemodynamic Variables Monitoring Form will be completed by the researcher (F.E.Ö) while monitoring the patient on the bedside monitor (Nihon Kohden, Tokyo). Participants who complete the Descriptive Characteristics Form, VAS, and VAS-A, and whose hemodynamic parameters are recorded, will be administered the stress ball application by Firdevs Ebru Özdemir and Nesrin Temiz.In addition to the clinic's routine treatment and care, patients in the study group will receive a stress ball during chest tube removal. 15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.
The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.
- Conditions
- Pain, Hemodynamic Changes, Anxiety
- Being tested
- Stress ball
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
Recently, the use of non-pharmacological methods applied by nurses has become increasingly widespread. One independent nursing practice for reducing pain and anxiety is the stress ball. A stress ball, one of these non-pharmacological methods, utilizes the sense of touch to divert attention and cognitive focus. This simple, reliable, and low-cost method reduces pain and anxiety by directing the mind to a salient stimulus.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Chest tubes are routinely removed on the second or third postoperative day in patients in the Cardiovascular Surgery Intensive Care Unit, and patients with stable hemodynamic variables are discharged to the clinic. Morphine (0.01 mg) and paracetamol (if necessary) are used for routine analgesic treatment during the intensive care unit. Before the stress ball application after open heart surgery, participants in the control and study groups will be asked to complete the Descriptive Characteristics Form, VAS, VAS-A, and Hemodynamic Variables Monitoring Form. The Hemodynamic Variables Monitoring Form will be completed by the researcher (F.E.Ö) while monitoring the patient on the bedside monitor (Nihon Kohden, Tokyo). Participants who complete the Descriptive Characteristics Form, The control group will not receive any treatment other than routine treatment and will be evaluated at the same time as the study group. |
| Stress ball group | Experimental | In addition to the clinic's routine treatment and care, patients in the study group will be treated with a stress ball during chest tube removal. 15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball application will last approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is complete, and then, under the supervision of the researcher, for an average of five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine t Receives: Other: Stress ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' pain levels with stress ball application
Visual Analog Scale (VAS): Developed by Freyd (1923), the VAS is a single, 10-cm-long scale that can be used vertically or horizontally to assess pain levels. A generally accepted, reliable, and easily applicable scale, the VAS consists of a 10-cm-long line with subjective descriptive statements at either end of the scale (0 cm = none at all and 10 cm = maximum presence). The individual places a mark on this 10-cm line at the appropriate location on the scale. The distance from the beginning of the scale to the mark is measured with a ruler, and the individual's pain level is numerically determined in cm.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Secondary outcomes (6)
anxiety
The VAS-A was developed to convert numerical values that cannot be measured numerically. A generally accepted, reliable, and easily applicable measurement tool in the world literature, the VAS consists of a 10-cm-long line with subjective descriptive statements at either end (0 cm = not present at all and 10 cm = most present). Research has shown that the VAS-A has been used to assess anxiety in patients before surgical interventions. Individuals place a mark at the appropriate location on this 10-cm line. The distance from the beginning of the scale to the mark is measured with a ruler, and the individual's anxiety level is numerically determined in cm. A low score on the VAS-A indicates a low/mild anxiety level, while a high score indicates a high/severe anxiety level.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Systolic blood pressure changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Diastolic blood pressure changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Heart rate changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Respiratory rate changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Oxygen saturation values changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start27 Nov 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Model description
- single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251270
- Sponsor's protocol ID
- Mersin_Unı
- Other IDs
- Tuğba ÇAM YANIK
- Acronym
- Stress ball
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yarahmadi S, Mohammadi N, Ardalan A, Najafizadeh H, Gholami M. The combined effects of cold therapy and music therapy on pain following chest tube removal among patients with cardiac bypass surgery. Complement Ther Clin Pract. 2018 May;31:71-75. doi: 10.1016/j.ctcp.2018.01.006. Epub 2018 Feb 6.
PubMed 29705484
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball on Pain, Anxiety Levels, and Hemodynamic Variables During Chest Tube Removal After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07251270
- Acronym / sponsor ID
- Stress ball / Mersin_Unı
- Conditions
- Pain, Hemodynamic Changes, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 26 Nov 2025 (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.
15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.
The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.
Detailed description
Chest tubes are routinely removed on the second or third postoperative day in patients in the Cardiovascular Surgery Intensive Care Unit, and patients with stable hemodynamic variables are discharged to the clinic. Morphine (0.01 mg) and paracetamol (if necessary) are used for routine analgesic treatment during the intensive care unit. Data will be collected between September 1, 2025, and September 1, 2026. Before the stress ball application after open heart surgery, participants in the control and study groups will be asked to complete the Descriptive Characteristics Form, VAS, VAS-A, and Hemodynamic Variables Monitoring Form. The Hemodynamic Variables Monitoring Form will be completed by the researcher (F.E.Ö) while monitoring the patient on the bedside monitor (Nihon Kohden, Tokyo). Participants who complete the Descriptive Characteristics Form, VAS, and VAS-A, and whose hemodynamic parameters are recorded, will be administered the stress ball application by Firdevs Ebru Özdemir and Nesrin Temiz.In addition to the clinic's routine treatment and care, patients in the study group will receive a stress ball during chest tube removal. 15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.
The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single blind
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Chest tubes are routinely removed on the second or third postoperative day in patients in the Cardiovascular Surgery Intensive Care Unit, and patients with stable hemodynamic variables are discharged to the clinic. Morphine (0.01 mg) and paracetamol (if necessary) are used for routine analgesic treatment during the intensive care unit. Before the stress ball application after open heart surgery, participants in the control and study groups will be asked to complete the Descriptive Characteristics Form, VAS, VAS-A, and Hemodynamic Variables Monitoring Form. The Hemodynamic Variables Monitoring Form will be completed by the researcher (F.E.Ö) while monitoring the patient on the bedside monitor (Nihon Kohden, Tokyo). Participants who complete the Descriptive Characteristics Form, The control group will not receive any treatment other than routine treatment and will be evaluated at the same time as the study group. |
| Stress ball group | Experimental | Other: Stress ballIn addition to the clinic's routine treatment and care, patients in the study group will be treated with a stress ball during chest tube removal. 15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball application will last approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is complete, and then, under the supervision of the researcher, for an average of five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine t |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Stress ballRecently, the use of non-pharmacological methods applied by nurses has become increasingly widespread. One independent nursing practice for reducing pain and anxiety is the stress ball. A stress ball, one of these non-pharmacological methods, utilizes the sense of touch to divert attention and cognitive focus. This simple, reliable, and low-cost method reduces pain and anxiety by directing the mind to a salient stimulus. | Other | Stress ball group |
Primary outcome
Participants' pain levels with stress ball application
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Visual Analog Scale (VAS): Developed by Freyd (1923), the VAS is a single, 10-cm-long scale that can be used vertically or horizontally to assess pain levels. A generally accepted, reliable, and easily applicable scale, the VAS consists of a 10-cm-long line with subjective descriptive statements at either end of the scale (0 cm = none at all and 10 cm = maximum presence). The individual places a mark on this 10-cm line at the appropriate location on the scale. The distance from the beginning of the scale to the mark is measured with a ruler, and the individual's pain level is numerically determined in cm.
6 secondary outcomes
anxiety
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Systolic blood pressure changes after stress ball
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Diastolic blood pressure changes after stress ball
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Heart rate changes after stress ball
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Respiratory rate changes after stress ball
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Oxygen saturation values changes after stress ball
Time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publication: PubMed 29705484Yarahmadi S, Mohammadi N, Ardalan A, Najafizadeh H, Gholami M. The combined effects of cold therapy and music therapy on pain following chest tube removal among patients with cardiac bypass surgery. Complement Ther Clin Pract. 2018 May;31:71-75. doi: 10.1016/j.ctcp.2018.01.006. Epub 2018 Feb 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball in people with Pain and Hemodynamic Changes, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' pain levels with stress ball application (time frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal). 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 NCT07251270, which also lists 1 linked publication.
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 12 Aug 2026.