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

NCT07251270 | Recruiting

• 2 other identifiers: Mersin_UnıTuğba ÇAM YANIK
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Hemodynamic Changes; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

Secondary Outcomes (6)

• anxiety

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

• Systolic blood pressure changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

• Diastolic blood pressure changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

• Heart rate changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

• Respiratory rate changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

Study Arms (2)

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. 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.

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

Other: Stress ball

Interventions

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.

Stress ball group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead
• Mersin University, School of Medicine: collaborator

Study Sites (1)

Turkey, Mersin University,

Yenişehir, Mersin, 33120, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 29705484 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Tuğba ÇAM YANIK

CONTACT

+905067703216; tugbacam@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since only patients in the study group will be administered, the study will not be blinded. Upon completion of the study, data from the study and control groups (coded as A or B) will be transferred to a computer by a researcher independent of the study, and the data will be analyzed and reported using a blinded technique by a statistician. Therefore, the study will be conducted as a single-blind clinical trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgical Diseases Nursing

Model Details: single blind

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 26, 2025
• Study Start: November 27, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)