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

NCT ID: NCT07251270

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-27
• Study Completion Date: 2026-06-20

Brief 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. 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.

Conditions

Pain; Hemodynamic Changes; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Stress ball

Intervention Type: 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.

Interventions

Stress ball

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University, School of Medicine

UNKNOWN

Sponsor Role: collaborator

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Tugba CAM YANIK

Assistant Professor of Surgical Diseases Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Turkey, Mersin University,

Yenişehir, Mersin, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Tuğba ÇAM YANIK

Role: CONTACT

tugbacam@mersin.edu.tr

+905067703216

Facility Contacts

Tuğba ÇAM YANIK, PhD

Role: primary

tugbacam@mersin.edu.tr

05067703216

References

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.

Reference Type: RESULT

PMID: 29705484 (View on PubMed)

Other Identifiers

Tuğba ÇAM YANIK

Identifier Type: OTHER

Identifier Source: secondary_id

Mersin_Unı

Identifier Type: -

Identifier Source: org_study_id