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NCT Number: NCT07251270

Effect of Stress Ball 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey, Mersin University,

Yenişehir, Mersin, 33120, Turkey (Türkiye)

Location status: Recruiting

Location contact

Tuğba ÇAM YANIK, PhD

CONTACT

[email protected]

05067703216

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress ball

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğba ÇAM YANIK

CONTACT

[email protected]

+905067703216

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Collaborators

  • Mersin University, School of Medicine

Registry information

Official study title

Effect of Stress Ball on Pain, Anxiety Levels, and Hemodynamic Variables During Chest Tube Removal After Open Heart Surgery

Acronym: Stress ball

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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