Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery (Stress ball)

December 1, 2025 updated by: Tugba CAM YANIK, Mersin University

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

Recruiting

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

Interventional

Enrollment (Estimated)

46

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

Study Locations

    • Mersin
      • Yenişehir, Mersin, Turkey (Türkiye), 33120
        • Recruiting
        • Turkey, Mersin University,
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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: 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

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

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.

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 (Actual)

November 27, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

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)?

NO

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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