NCT07248085

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Chest TubeRapid Relaxation ExerciseCold ApplicationPainAnxietyPatient Satisfaction

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    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

    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

    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

Study Arms (3)

Cold Application

EXPERIMENTAL

Cold Application

Other: Cold Application

Rapid Relaxation Exercise

EXPERIMENTAL

Rapid Relaxation Exercise

Other: Rapid Relaxation Exercise

Standard care

NO INTERVENTION

In our study, no intervention other than the clinical protocol will be applied to the control group patients before chest tube removal.

Interventions

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.

Cold Application

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.

Rapid Relaxation Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Unıversty

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Dr. Tülay KILINÇ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

November 15, 2025

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations