Pulmonary ComplicationNCT06078644
Respiratory Exercise Diary in Major Abdominal Surgery
A study testing respiratory exercise diary in people with Pulmonary Complication, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pulmonary complications are common and lead to increased morbidity and mortality in patients. These complications are observed especially after major surgical interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complication
- What is being tested?
- respiratory exercise diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2023to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective surgery
- Receiving general anesthesia
- Having major abdominal surgery (colorectal surgery, gastrectomy, liver resection, pancreatectomy)
- Staying in the general surgery service for at least 3 days after the surgery
- Becoming literate
Who cannot join
- Psychoactive drug use
- Having Alzheimer's or dementia
- Having chronic respiratory diseases (COPD, asthma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Respiratory Exercise Diary Use on Pulmonary Complications and Functional Capacity in Major Abdominal Surgery: A Randomized Controlled Study
Postoperative pulmonary complications are common and lead to increased morbidity and mortality in patients. These complications are observed especially after major surgical interventions. Breathing exercises performed with or without the use of a device are extremely important in preventing postoperative pulmonary complications. Breathing exercises that increase total lung capacity by encouraging the use of the diaphragm reverse alveolar collapse and postoperative hypoxemia. This study aim to determine the effect of postoperative respiratory exercise diary use in patients undergoing major abdominal surgery on dyspnea, fatigue, respiratory parameters (respiratory rate, SPO2, cough, sputum), early pulmonary complications, spirometry use and functional capacity.The research is planned to be conducted in a single-blind, randomized controlled manner. In the study, 60 patients (30 intervention and 30 control) who underwent major abdominal surgery will be included.Data will be collected using the Patient Introduction Form, Visual Analogue Scale, Medical Research Board Scale, 2-minute walk test, breathing exercise diary and patient follow-up chart.Patients in the intervention and control groups will be visited by the researcher for 3 postoperative days, respiratory parameters, cough, and sputum status will be recorded in the patient follow-up chart, and the use of a respiratory exercise diary will be evaluated.
- Conditions
- Pulmonary Complication
- Being tested
- respiratory exercise diary
- Keywords
- general surgery, breathing exercises, dyspnea, fatigue
- Medical subject headings
- Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory exercise diaryOther
Patients in the intervention group will be asked to perform breathing exercises in the form of using a spirometer 10 times every hour during the preoperative period while they are awake for three days, starting from the first day after the surgery. Patients in this group will be given a breathing exercise diary.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in this group will be asked to perform breathing exercises in the form of using a spirometer 10 times every hour during the preoperative period while they are awake for three days, starting from the first day after the surgery. Patients in this group will be given a breathing exercise diary. Receives: Other: respiratory exercise diary |
| Control group | No intervention | Patients in this group will not undergo any treatment and will continue to receive care according to their clinical routine. In the clinic, when patients are admitted to the hospital, nurses give them a spirometer during the pre-operative period and it is stated that they should use it before and after the surgery. After the data collection tools are applied to the patients in this group, they will be asked how many times a day they use a spirometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry use
The respiratory exercise diary was prepared in line with the literature for patients to record the time, number and frequency of breathing exercises they performed using a spirometer. There is an illustrated information note to remind you how and how often the spirometer should be used, and a chart where patients will write the number and frequency of exercises they did with the spirometry for three days before and after the surgery, opposite the relevant clock.
Measured: 1-3 days
Secondary outcomes (7)
dyspnea
The presence of dyspnea will be evaluated using the Medical Research Board Scale (MAKS). This scale is a five-item scale based on various physical activities that create a feeling of dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea. MAX is easy to administer because it allows patients to indicate the extent to which shortness of breath affects their mobility.
Measured: 1-3 days
fatigue
In the study, fatigue severity will be evaluated using a visual analog scale. The range of 0 and 10 cm is determined on a line. In the fatigue severity assessment, 0 (zero) means "I do not feel tired" and 10 means "I feel very tired." An increase in score indicates that the patient's fatigue severity is increasing.
Measured: 1-3 days
Pulmonary functional capacity
In the 2-minute walk test, two points are selected 30 meters away from each other and a mark is placed every 3 meters. The patient walks quickly within 2 minutes and the distance traveled is recorded. Walking tests used to assess functional capacity are simple, inexpensive and safe performance-based tests that provide information about individuals' functional exercise capacity compared to laboratory-based aerobic capacity indices such as cycling, treadmill and arm ergometry, which are expensive and not always available.
Measured: 1-3 days
Respiratory rate
Preoperative and postoperative respiratory rate will be recorded in the patient follow-up chart.
Measured: 1-3 days
Oxygen saturation
Preoperative and postoperative oxygen saturation will be recorded in the patient follow-up chart.
Measured: 1-3 days
Cough
The presence of cough after surgery will be recorded in the patient follow-up chart.
Measured: 1-3 days
Mucus
The presence of mucus after surgery will be recorded in the patient follow-up chart.
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start9 Oct 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Akutay, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078644
- Sponsor's protocol ID
- Erüsbf
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toor H, Kashyap S, Yau A, Simoni M, Farr S, Savla P, Kounang R, Miulli DE. Efficacy of Incentive Spirometer in Increasing Maximum Inspiratory Volume in an Out-Patient Setting. Cureus. 2021 Oct 4;13(10):e18483. doi: 10.7759/cureus.18483. eCollection 2021 Oct.
PubMed 34754645Unver S, Kivanc G, Alptekin HM. Deep breathing exercise education receiving and performing status of patients undergoing abdominal surgery. Int J Health Sci (Qassim). 2018 Jul-Aug;12(4):35-38.
PubMed 30022901Westerdahl E, Lindmark B, Eriksson T, Hedenstierna G, Tenling A. The immediate effects of deep breathing exercises on atelectasis and oxygenation after cardiac surgery. Scand Cardiovasc J. 2003 Dec;37(6):363-7. doi: 10.1080/14017430310014984.
PubMed 14668188McTier L, Botti M, Duke M. Patient participation in pulmonary interventions to reduce postoperative pulmonary complications following cardiac surgery. Aust Crit Care. 2016 Feb;29(1):35-40. doi: 10.1016/j.aucc.2015.04.001. Epub 2015 May 1.
PubMed 25939547
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Exercise Diary Use on Pulmonary Complications and Functional Capacity in Major Abdominal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06078644
- Acronym / sponsor ID
- Erüsbf
- Conditions
- Pulmonary Complication
- Keywords
- general surgery, breathing exercises, dyspnea, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Oct 2023 (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.
Postoperative pulmonary complications are common and lead to increased morbidity and mortality in patients. These complications are observed especially after major surgical interventions. Breathing exercises performed with or without the use of a device are extremely important in preventing postoperative pulmonary complications. Breathing exercises that increase total lung capacity by encouraging the use of the diaphragm reverse alveolar collapse and postoperative hypoxemia. This study aim to determine the effect of postoperative respiratory exercise diary use in patients undergoing major abdominal surgery on dyspnea, fatigue, respiratory parameters (respiratory rate, SPO2, cough, sputum), early pulmonary complications, spirometry use and functional capacity.The research is planned to be conducted in a single-blind, randomized controlled manner. In the study, 60 patients (30 intervention and 30 control) who underwent major abdominal surgery will be included.Data will be collected using the Patient Introduction Form, Visual Analogue Scale, Medical Research Board Scale, 2-minute walk test, breathing exercise diary and patient follow-up chart.Patients in the intervention and control groups will be visited by the researcher for 3 postoperative days, respiratory parameters, cough, and sputum status will be recorded in the patient follow-up chart, and the use of a respiratory exercise diary will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: respiratory exercise diaryPatients in this group will be asked to perform breathing exercises in the form of using a spirometer 10 times every hour during the preoperative period while they are awake for three days, starting from the first day after the surgery. Patients in this group will be given a breathing exercise diary. |
| Control group | No intervention | –Patients in this group will not undergo any treatment and will continue to receive care according to their clinical routine. In the clinic, when patients are admitted to the hospital, nurses give them a spirometer during the pre-operative period and it is stated that they should use it before and after the surgery. After the data collection tools are applied to the patients in this group, they will be asked how many times a day they use a spirometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing elective surgery
- Receiving general anesthesia
- Having major abdominal surgery (colorectal surgery, gastrectomy, liver resection, pancreatectomy)
- Staying in the general surgery service for at least 3 days after the surgery
- Becoming literate
Key exclusion criteria (3 listed)
- Psychoactive drug use
- Having Alzheimer's or dementia
- Having chronic respiratory diseases (COPD, asthma)
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 |
|---|---|---|
| respiratory exercise diaryPatients in the intervention group will be asked to perform breathing exercises in the form of using a spirometer 10 times every hour during the preoperative period while they are awake for three days, starting from the first day after the surgery. Patients in this group will be given a breathing exercise diary. | Other | Intervention group |
Primary outcome
Spirometry use
Time frame: 1-3 days
The respiratory exercise diary was prepared in line with the literature for patients to record the time, number and frequency of breathing exercises they performed using a spirometer. There is an illustrated information note to remind you how and how often the spirometer should be used, and a chart where patients will write the number and frequency of exercises they did with the spirometry for three days before and after the surgery, opposite the relevant clock.
7 secondary outcomes
dyspnea
Time frame: 1-3 days
fatigue
Time frame: 1-3 days
Pulmonary functional capacity
Time frame: 1-3 days
Respiratory rate
Time frame: 1-3 days
Oxygen saturation
Time frame: 1-3 days
Cough
Time frame: 1-3 days
Mucus
Time frame: 1-3 days
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 14 Apr 2026.
- Background: PubMed 34754645Toor H, Kashyap S, Yau A, Simoni M, Farr S, Savla P, Kounang R, Miulli DE. Efficacy of Incentive Spirometer in Increasing Maximum Inspiratory Volume in an Out-Patient Setting. Cureus. 2021 Oct 4;13(10):e18483. doi: 10.7759/cureus.18483. eCollection 2021 Oct.
- Background: PubMed 30022901Unver S, Kivanc G, Alptekin HM. Deep breathing exercise education receiving and performing status of patients undergoing abdominal surgery. Int J Health Sci (Qassim). 2018 Jul-Aug;12(4):35-38.
- Background: PubMed 14668188Westerdahl E, Lindmark B, Eriksson T, Hedenstierna G, Tenling A. The immediate effects of deep breathing exercises on atelectasis and oxygenation after cardiac surgery. Scand Cardiovasc J. 2003 Dec;37(6):363-7. doi: 10.1080/14017430310014984.
- Background: PubMed 25939547McTier L, Botti M, Duke M. Patient participation in pulmonary interventions to reduce postoperative pulmonary complications following cardiac surgery. Aust Crit Care. 2016 Feb;29(1):35-40. doi: 10.1016/j.aucc.2015.04.001. Epub 2015 May 1.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Complication
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
RecruitingObservational study
Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies
Mortality in Sickle Cell, Sickle Cell Cardiopulmonary Complications
Not yet recruiting
AI-Assisted Education Before Surgery to Prevent Lung Complications in Older Surgical Patients
Postoperative Pulmonary Complications
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory exercise diary in people with Pulmonary Complication, run by TC Erciyes 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 5 inclusion and 3 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 14 Apr 2026. 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?
Spirometry use (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078644, which also lists 4 linked publications.
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 14 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.