- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251270
Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery (Stress ball)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuğba ÇAM YANIK
- Phone Number: +905067703216
- Email: tugbacam@mersin.edu.tr
Study Locations
-
-
Mersin
-
Yenişehir, Mersin, Turkey (Türkiye), 33120
- Recruiting
- Turkey, Mersin University,
-
Contact:
- Tuğba ÇAM YANIK, PhD
- Phone Number: 05067703216
- Email: tugbacam@mersin.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
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, The control group will not receive any treatment other than routine treatment and will be evaluated at the same time as the study group. |
|
|
Experimental: Stress ball group
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before, immediately after, 15 minutes and 30 minutes after chest tube removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety
Time Frame: Before, immediately after, 15 minutes and 30 minutes after chest tube removal
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Before, immediately after, 15 minutes and 30 minutes after chest tube removal
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mersin_Unı
- Tuğba ÇAM YANIK (Other Identifier: Mersin University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Stress ball
-
Bedriye Cansu DEMİRKIRANCompletedDepression | Quality of Life | Irritable Bowel Syndrome | Stress | AnxietyTurkey
-
University of BaghdadCompleted
-
Agri Ibrahim Cecen UniversityCompletedElective Cesarean Section | Non Stress Test (NST)Turkey (Türkiye)
-
Artvin Coruh UniversityRecruitingGastrointestinal System CancerTurkey (Türkiye)
-
Ataturk UniversityNot yet recruitingChemotherapy | Breast Cancer Early Stage Breast Cancer (Stage 1-3)
-
Harran UniversitySanliurfa Harran UniversityNot yet recruitingExamine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women
-
Istanbul University - CerrahpasaCompleted
-
Izmir Bakircay UniversityCompleted
-
Kırklareli UniversityCompletedAnxiety | Pregnancy RelatedTurkey
-
TC Erciyes UniversityCompleted