Lung SurgeryNCT06460259
The Effect of Breathing Exercises on Pain, Anxiety, Dyspnea, and Insomnia in Patients Undergoing Lung Surgery.
A study testing Breathing Exercise in people with Lung Surgery, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Surgical treatment is performed with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Surgery
- What is being tested?
- Breathing Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having undergone VATS or wedge resection surgery,
- Having orientation to place and time,
- Being communicative,
- Having no visual or hearing impairment.
Who cannot join
- Having a mental health issue that would hinder communication,
- Having any nasal pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Surgical treatment is performed with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. The wedge resection method is utilized in both malignant and non-malignant pulmonary pathologies (such as bronchiectasis, aspergilloma, non-tuberculous mycobacteria, tuberculosis, fungal infections, inflammatory pseudotumors, hydatid cyst, and benign masses). Following surgical procedures such as Video-Assisted Thorascopic Surgery (VATS) and wedge resection, side effects and complications such as atelectasis, pneumonia, acute respiratory distress syndrome, prolonged air leakage, chylothorax, sepsis, pneumothorax, pulmonary embolism, empyema, bronchopleural fistula, pain, anxiety, dyspnea, fatigue, and insomnia can occur.
Non-pharmacological methods are observed to increase comfort and control in patients, thereby enhancing their quality of life. Non-pharmacological interventions such as music therapy, hot or cold therapy, hypnosis, aromatherapy, massage, progressive relaxation exercises, deep breathing exercises, pursed lip breathing, yoga, and meditation can be employed in the management of postoperative symptoms such as pain, anxiety, dyspnea, insomnia, and fatigue. Studies involving breathing exercises have shown that they reduce anxiety and pain scores after exercise. Alternate nostril breathing, a yoga practice, is considered one of the best breathing exercises for health and fitness. It has positive effects on dyspnea, anxiety, stress, and sleep disorders.
Read the detailed description
Surgical treatment is carried out with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. The wedge resection method is utilized in both malignant and non-malignant pulmonary pathologies (such as bronchiectasis, aspergilloma, non-tuberculous mycobacteria, tuberculosis, fungal infections, inflammatory pseudotumors, hydatid cyst, and benign masses). Following surgical procedures such as VATS and wedge resection, side effects and complications such as atelectasis, pneumonia, acute respiratory distress syndrome, prolonged air leakage, chylothorax, sepsis, pneumothorax, pulmonary embolism, empyema, bronchopleural fistula, pain, anxiety, dyspnea, fatigue, and insomnia can occur.Non-pharmacological methods are observed to increase comfort and control in patients, thereby enhancing their quality of life. Non-pharmacological interventions such as music therapy, hot or cold therapy, hypnosis, aromatherapy, massage, progressive relaxation exercises, deep breathing exercises, pursed lip breathing, yoga, and meditation can be employed in the management of postoperative symptoms such as pain, anxiety, dyspnea, insomnia, and fatigue. Studies involving breathing exercises have shown that they reduce anxiety and pain scores after exercise. Alternate nostril breathing, a yoga practice, is considered one of the best breathing exercises for health and fitness. It has positive effects on dyspnea, anxiety, stress, and sleep disorders. Breathing exercises aim to improve individuals' quality of life and mitigate the effects of the disease, providing inexpensive and side-effect-free practices.Nurses should empower individuals to better manage symptoms such as experiencing less pain, reduced anxiety, alleviation or reduction of dyspnea, insomnia, fatigue, and other symptoms following surgical procedures. No study has been found that examines the effect of alternative nostril breathing exercises on pain, anxiety, dyspnea, fatigue, and insomnia symptoms in patients undergoing lung surgery. Our study aims to contribute to the literature by evaluating the effect of breathing exercises on pain, anxiety, dyspnea, and insomnia in patients undergoing lung resection and VATS procedures.Therefore, this study is planned to determine the effect of breathing exercises on pain, anxiety, dyspnea, and insomnia in patients undergoing lung resection and VATS procedures in a public hospital.
- Conditions
- Lung Surgery
- Being tested
- Breathing Exercise
- Keywords
- Breathing exercises, Insomnia, Pain, Anxiety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseBehavioural
He individual will be seated in a quiet environment in a semi-fowler or fowler position with their feet pointing forward. Then, they will be asked to join their hands on their abdomen and breathe normally while focusing on their breath. They will ensure their shoulders are relaxed, their body is loose, and they will inhale and exhale slowly and deeply through the nose without rushing.Next, while sitting upright with relaxed muscles, they will close their eyes, block their right nostril with their thumb or ring finger, inhale as much air as possible through the left nostril, and hold their breath. Then, they will block the left nostril with their ring finger or thumb and exhale slowly through the right nostril. The same process will be repeated for the left nostril. They will continue this process for approximately 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients undergoing VATS or wedge resection procedures will be informed and their consent will be obtained prior to the procedure. Individuals who consent and meet the inclusion criteria will fill out a personal information form and then be randomly assigned to groups using simple randomization method. Breathing exercises will be taught individually to participants in the experimental group by the researcher. In the experimental group, breathing exercises will be performed approximately 10 minutes, four times a day, starting from the first day after oral intake. Receives: Behavioral: Breathing Exercise |
| Control Group | No intervention | No intervention other than routine nursing care will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) - Pain Scale
A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.
Measured: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
Visual Analog Scale (VAS) - Dyspnea Scale
The Visual Analog Scale (VAS) is applied by marking with a pencil on a horizontal or vertical line of one hundred millimeters. The 0 mm point of the line indicates no dyspnea, while the 100 mm point indicates the most severe dyspnea possible. The patient marks the severity of their current respiratory distress on the scale by using these two degrees as criteria.
Measured: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
State-Trait Anxiety Inventory
he development of the State-Trait Anxiety Inventory was conducted by Spielberger and his colleagues (1970), and it consists of two subscales: state anxiety and trait anxiety, each comprising 20 items. The scores obtained from both scales theoretically range between 20 and 80. A large score indicates a high level of anxiety, a small score indicates a low level of anxiety.
Measured: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
Secondary outcomes (1)
Richard Campbell Sleep Scale
It is a scale consisting of 6 items that assess the depth of nighttime sleep, the time it takes to fall asleep, the frequency of awakenings, the duration of wakefulness upon awakening, the quality of sleep, and the level of noise in the environment. Scores on the scale range from "0-25" indicating very poor sleep to "76-100" indicating very good sleep. While evaluating the total score of the scale based on 5 items, the 6th item, which assesses the level of noise in the environment, is excluded from the total score assessment. As the score on the scale increases, the quality of patients' sleep also increases.
Measured: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Aug 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gündoğdu, KTO Karatay University
- Investigators
- Fatma Gündoğdu, PhD, Principal investigator, KTO Karatay UniversityHasibe Okutan, PhD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460259
- Sponsor's protocol ID
- 2023/026
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researcher at Konya City Hospital will collect the data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercises on Pain, Anxiety, Dyspnea, and Insomnia in Patients Undergoing Lung Surgery.
- ClinicalTrials.gov ID
- NCT06460259
- Acronym / sponsor ID
- 2023/026
- Conditions
- Lung Surgery
- Keywords
- Breathing exercises, Insomnia, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 14 Jun 2024 (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.
Surgical treatment is performed with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. The wedge resection method is utilized in both malignant and non-malignant pulmonary pathologies (such as bronchiectasis, aspergilloma, non-tuberculous mycobacteria, tuberculosis, fungal infections, inflammatory pseudotumors, hydatid cyst, and benign masses). Following surgical procedures such as Video-Assisted Thorascopic Surgery (VATS) and wedge resection, side effects and complications such as atelectasis, pneumonia, acute respiratory distress syndrome, prolonged air leakage, chylothorax, sepsis, pneumothorax, pulmonary embolism, empyema, bronchopleural fistula, pain, anxiety, dyspnea, fatigue, and insomnia can occur.
Non-pharmacological methods are observed to increase comfort and control in patients, thereby enhancing their quality of life. Non-pharmacological interventions such as music therapy, hot or cold therapy, hypnosis, aromatherapy, massage, progressive relaxation exercises, deep breathing exercises, pursed lip breathing, yoga, and meditation can be employed in the management of postoperative symptoms such as pain, anxiety, dyspnea, insomnia, and fatigue. Studies involving breathing exercises have shown that they reduce anxiety and pain scores after exercise. Alternate nostril breathing, a yoga practice, is considered one of the best breathing exercises for health and fitness. It has positive effects on dyspnea, anxiety, stress, and sleep disorders.
Detailed description
Surgical treatment is carried out with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. The wedge resection method is utilized in both malignant and non-malignant pulmonary pathologies (such as bronchiectasis, aspergilloma, non-tuberculous mycobacteria, tuberculosis, fungal infections, inflammatory pseudotumors, hydatid cyst, and benign masses). Following surgical procedures such as VATS and wedge resection, side effects and complications such as atelectasis, pneumonia, acute respiratory distress syndrome, prolonged air leakage, chylothorax, sepsis, pneumothorax, pulmonary embolism, empyema, bronchopleural fistula, pain, anxiety, dyspnea, fatigue, and insomnia can occur.Non-pharmacological methods are observed to increase comfort and control in patients, thereby enhancing their quality of life. Non-pharmacological interventions such as music therapy, hot or cold therapy, hypnosis, aromatherapy, massage, progressive relaxation exercises, deep breathing exercises, pursed lip breathing, yoga, and meditation can be employed in the management of postoperative symptoms such as pain, anxiety, dyspnea, insomnia, and fatigue. Studies involving breathing exercises have shown that they reduce anxiety and pain scores after exercise. Alternate nostril breathing, a yoga practice, is considered one of the best breathing exercises for health and fitness. It has positive effects on dyspnea, anxiety, stress, and sleep disorders. Breathing exercises aim to improve individuals' quality of life and mitigate the effects of the disease, providing inexpensive and side-effect-free practices.Nurses should empower individuals to better manage symptoms such as experiencing less pain, reduced anxiety, alleviation or reduction of dyspnea, insomnia, fatigue, and other symptoms following surgical procedures. No study has been found that examines the effect of alternative nostril breathing exercises on pain, anxiety, dyspnea, fatigue, and insomnia symptoms in patients undergoing lung surgery. Our study aims to contribute to the literature by evaluating the effect of breathing exercises on pain, anxiety, dyspnea, and insomnia in patients undergoing lung resection and VATS procedures.Therefore, this study is planned to determine the effect of breathing exercises on pain, anxiety, dyspnea, and insomnia in patients undergoing lung resection and VATS procedures in a public hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Breathing ExercisePatients undergoing VATS or wedge resection procedures will be informed and their consent will be obtained prior to the procedure. Individuals who consent and meet the inclusion criteria will fill out a personal information form and then be randomly assigned to groups using simple randomization method. Breathing exercises will be taught individually to participants in the experimental group by the researcher. In the experimental group, breathing exercises will be performed approximately 10 minutes, four times a day, starting from the first day after oral intake. |
| Control Group | No intervention | –No intervention other than routine nursing care will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having undergone VATS or wedge resection surgery,
- Having orientation to place and time,
- Being communicative,
- Having no visual or hearing impairment.
Key exclusion criteria (2 listed)
- Having a mental health issue that would hinder communication,
- Having any nasal pathology.
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 |
|---|---|---|
| Breathing ExerciseHe individual will be seated in a quiet environment in a semi-fowler or fowler position with their feet pointing forward. Then, they will be asked to join their hands on their abdomen and breathe normally while focusing on their breath. They will ensure their shoulders are relaxed, their body is loose, and they will inhale and exhale slowly and deeply through the nose without rushing.Next, while sitting upright with relaxed muscles, they will close their eyes, block their right nostril with their thumb or ring finger, inhale as much air as possible through the left nostril, and hold their breath. Then, they will block the left nostril with their ring finger or thumb and exhale slowly through the right nostril. The same process will be repeated for the left nostril. They will continue this process for approximately 2 minutes. | Behavioural | Experimental Group |
Primary outcome
Visual Analog Scale (VAS) - Pain Scale
Time frame: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.
Visual Analog Scale (VAS) - Dyspnea Scale
Time frame: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
The Visual Analog Scale (VAS) is applied by marking with a pencil on a horizontal or vertical line of one hundred millimeters. The 0 mm point of the line indicates no dyspnea, while the 100 mm point indicates the most severe dyspnea possible. The patient marks the severity of their current respiratory distress on the scale by using these two degrees as criteria.
State-Trait Anxiety Inventory
Time frame: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
he development of the State-Trait Anxiety Inventory was conducted by Spielberger and his colleagues (1970), and it consists of two subscales: state anxiety and trait anxiety, each comprising 20 items. The scores obtained from both scales theoretically range between 20 and 80. A large score indicates a high level of anxiety, a small score indicates a low level of anxiety.
1 secondary outcome
Richard Campbell Sleep Scale
Time frame: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. The researcher at Konya City Hospital will collect the data.
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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. This study is not recruiting at the moment.
Fatma Gündoğdu, PhD principal investigator
KTO Karatay University
Hasibe Okutan, PhD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise in people with Lung Surgery, run by KTO Karatay 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) - Pain Scale (time frame: First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.). 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 4 Sep 2025.