The Effect of Rapid Relaxation Exercise and Cold Application on Pain, Anxiety, and Satisfaction Before Chest Tube Removal

November 18, 2025 updated by: Tülay KILINÇ, Ataturk University
A chest tube is inserted to drain air, fluid, or blood from the pleural space and is vital for restoring respiratory function in the postoperative period. However, tube removal is often described by patients as one of the most painful and anxiety-provoking experiences. The sudden negative pressure changes that occur during the procedure, the stretching of the tissues, and the separation of the tube from the pleural tissue cause pain. This leads not only to physical discomfort but also to increased anxiety. Effectively controlling pain after surgical procedures is crucial for reducing complications and improving patient satisfaction. While pharmacological methods are often the first choice, interest in non-pharmacological approaches is increasing due to side effects and cost. In this context, rapid relaxation exercises and cold application are among the methods that are easy to implement, have no side effects, and have proven effective in nursing care. Rapid relaxation exercises are a simple breathing and muscle control technique that allows individuals to relax quickly by reducing muscle tension. This method balances the autonomic nervous system, producing both physiological and psychological relief. This helps reduce pain perception, control anxiety, and improve patient confidence. Cold application, on the other hand, reduces nerve conduction velocity by causing regional vasoconstriction and raises the pain threshold, providing an analgesic effect. Literature indicates that cold application is effective in reducing pain during invasive procedures such as chest tube removal and also increases patient satisfaction. Based on this information, the combined use of rapid relaxation exercise and cold application before chest tube removal may have a synergistic effect in reducing pain and anxiety. Furthermore, the noninvasiveness, ease of application, and cost-effectiveness of these methods provide significant advantages for nursing practice.This study was designed to determine the effects of rapid relaxation exercise and cold application before hest tube removal on pain, anxiety, and patient satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open-heart surgery is a major surgical procedure frequently used in the treatment of cardiovascular diseases. After such operations, a chest tube is usually placed to drain air, fluid, and blood accumulated in the chest cavity. While a chest tube is vital in the postoperative period, it can cause intense pain, anxiety, and discomfort in patients during its removal. The literature reports that negative experiences during this process can significantly impact patient satisfaction, comfort, and overall well-being. The pain felt during chest tube removal is usually sudden, sharp, and short-lived; however, this pain can deepen the physical and psychological dimensions of the trauma experienced by the individual. Furthermore, increased anxiety can lead to undesirable physiological changes in cardiac patients, impairing hemodynamic stability. Therefore, investigating the effectiveness of non-invasive, low-cost, and easy-to-implement nursing interventions is crucial for improving the quality of patient care. Cold application (cryotherapy) and relaxation exercises are among the frequently used complementary methods to reduce pain and anxiety in the postoperative period. Cold application provides an analgesic effect by slowing nerve conduction; Rapid relaxation exercises, on the other hand, activate the parasympathetic nervous system, providing psychological relief. However, there is insufficient scientific evidence regarding the effectiveness of this technique during chest tube removal. Furthermore, randomized controlled trials examining the combined use of these interventions are limited. This study aimed to evaluate the effects of rapid relaxation exercises and cold application on pain, anxiety, and patient satisfaction before chest tube removal.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Conscious, oriented, and cooperative.
  • Can speak and understand Turkish.
  • Does not have any psychiatric illness.
  • Has a chest tube and is in a stable general condition.
  • Has undergone a chest tube procedure for the first time.
  • Is 18 years of age or older.
  • Has not taken analgesics or sedatives 4 hours before the procedure.
  • Has no vision or hearing problems.
  • Volunteers to participate in the study.

Exclusion Criteria:

  • Patients with any cognitive or psychological disorders
  • Those who have had a chest tube placed before,
  • Those who are on a mechanical ventilator (intubated),
  • Those with chronic pain and routine painkiller use,
  • Those with vision or hearing problems,
  • Those who are taking analgesics immediately before chest tube removal.
  • Patients who did not volunteer to participate 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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cold Application
Other: Cold Application
Patients will receive routine monitoring, pharmacological treatment, and nursing care in the unit where the study is conducted. Cold application ice packs will be placed around the patient's chest tube insertion site. The ice pack, which has been kept in the research clinic's refrigerator for 72 hours, measured with a barbeque thermometer at -10°C, and distributed evenly when cooled, will be placed on the chest tube dressing. Since skin temperature must fall below 13.6°C for cold application to have a local analgesic effect, the patient's skin temperature will be measured at one-minute intervals throughout the cold application. When the application reaches 13.6°C, the application will be stopped, and the physician will be notified that the patient is ready. During the cold application, the applied area will be checked for redness, irritation, and discoloration.
Experimental: Rapid Relaxation Exercise
Other: Rapid Relaxation Exercise
Individuals in the rapid relaxation exercise group will be led by the researcher in the patient room or examination room to perform a breathing exercise. The exercise will last approximately 5-10 minutes. The environment will be quiet, at room temperature, and well-ventilated. The exercises will be performed by ensuring the patient is seated in a comfortable position, and the following steps will be followed. Patients will be asked to close their eyes and observe the up-and-down movement of their abdominal muscles as they breathe in and out. The same exercise will be repeated for seven cycles. Patients are asked to inhale deeply and slowly to revitalize their entire body and feel a sense of lightness. On the exhale, they are asked to completely relax all their muscles by making the sound "A" (A-Kara). Once completely relaxed, they are encouraged to blink their eyes open several times.
No Intervention: Standard care
In our study, no intervention other than the clinical protocol will be applied to the control group patients before chest tube removal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 15 minutes
This scale, developed by Price et al. (1983), begins with 0 representing "no pain" and ends with 10 representing "unbearable pain." The patient is asked to score between 0 and 10 to express the severity of pain. The marked value represents the patient's pain score.
15 minutes
State Anxiety Inventory
Time Frame: 15 minutes
This scale was developed by Spielberger et al. (1970) to measure the anxiety levels of individuals aged 14 and over. This study will use the 20-item "State Anxiety Inventory Scale" section of this two-section, 40-item scale. This Likert-type scale is rated according to the severity of the situation represented by the items: "not at all": 1, "a little": 2, "a lot": 3, and "completely": 4. This scale includes direct and reversed statements (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20), and the scores for the reversed statements are calculated by converting them. Scores are adjusted so that 1 point = 4, 2 points = 3, 3 points = 2, and 4 points = 1. The scores for the other statements are taken as is and added. The anxiety score is obtained by subtracting the total score obtained from the reversed statements from the total score obtained for the direct statements and adding the predetermined constant value (the constant value for the state anxiety scale is 50). Possible scores for this i
15 minutes
Satisfaction Assessment Scale
Time Frame: 15 minutes
This scale consists of a 10-cm vertical line without numbers to determine an individual's level of satisfaction. At one end of the line are the words "I am not satisfied at all" and at the other end are the words "I am very satisfied." The individual determines their level of satisfaction by considering all the components affecting them regarding the medical care provided and marks the point on the line corresponding to this state. The literature supports the use of this scale to measure satisfaction levels and has been reported to yield more reliable results. This scale will be used in the study to determine the level of satisfaction experienced by the individual with the intervention.
15 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • tulay39

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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