Open Heart SurgeryNCT07248085
The Effect of Rapid Relaxation Exercise and Cold Application on Pain, Anxiety, and Satisfaction Before Chest Tube Removal
A study testing Cold Application and Rapid Relaxation Exercise in people with Open Heart Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Cold Application and Rapid Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Has not taken analgesics or sedatives 4 hours before the procedure.
- Has no vision or hearing problems.
- Volunteers to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Open Heart Surgery
- Being tested
- Cold Application, Rapid Relaxation Exercise
- Keywords
- Chest Tube, Rapid Relaxation Exercise, Cold Application, Pain, Anxiety, Patient Satisfaction
- Medical subject headings
- Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationOther
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.
Rapid Relaxation ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Application | Experimental | Cold Application Receives: Other: Cold Application |
| Rapid Relaxation Exercise | Experimental | Rapid Relaxation Exercise Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay KILINÇ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248085
- Sponsor's protocol ID
- tulay39
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rapid Relaxation Exercise and Cold Application on Pain, Anxiety, and Satisfaction Before Chest Tube Removal
- ClinicalTrials.gov ID
- NCT07248085
- Acronym / sponsor ID
- tulay39
- Conditions
- Open Heart Surgery
- Keywords
- Chest Tube, Rapid Relaxation Exercise, Cold Application, Pain, Anxiety, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cold Application | Experimental | Other: Cold ApplicationCold Application |
| Rapid Relaxation Exercise | Experimental | Other: Rapid Relaxation ExerciseRapid 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold ApplicationPatients 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. | Other | Cold Application |
| Rapid Relaxation ExerciseIndividuals 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. | Other | Rapid Relaxation Exercise |
Primary outcome
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application and Rapid Relaxation Exercise in people with Open Heart Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tülay KILINÇ (05376592051, tlyhmsre@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.