- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06078644
Respiratory Exercise Diary in Major Abdominal Surgery
April 10, 2026 updated by: Seda Akutay, TC Erciyes University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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 Locations
-
-
-
Kayseri, Turkey (Türkiye)
- Erciyes University
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Psychoactive drug use
- Having Alzheimer's or dementia
- Having chronic respiratory diseases (COPD, asthma)
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1-3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dyspnea
Time Frame: 1-3 days
|
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.
|
1-3 days
|
|
fatigue
Time Frame: 1-3 days
|
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.
|
1-3 days
|
|
Pulmonary functional capacity
Time Frame: 1-3 days
|
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.
|
1-3 days
|
|
Respiratory rate
Time Frame: 1-3 days
|
Preoperative and postoperative respiratory rate will be recorded in the patient follow-up chart.
|
1-3 days
|
|
Oxygen saturation
Time Frame: 1-3 days
|
Preoperative and postoperative oxygen saturation will be recorded in the patient follow-up chart.
|
1-3 days
|
|
Cough
Time Frame: 1-3 days
|
The presence of cough after surgery will be recorded in the patient follow-up chart.
|
1-3 days
|
|
Mucus
Time Frame: 1-3 days
|
The presence of mucus after surgery will be recorded in the patient follow-up chart.
|
1-3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Unver 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.
- Westerdahl 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.
- McTier 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.
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 (Actual)
October 9, 2023
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
September 27, 2023
First Submitted That Met QC Criteria
October 9, 2023
First Posted (Actual)
October 12, 2023
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Erüsbf
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.
Clinical Trials on Pulmonary Complication
-
St. Anne's University Hospital Brno, Czech RepublicCompletedPulmonary Complication | Cardiovascular ComplicationCzechia
-
Hospital Israelita Albert EinsteinAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); University... and other collaboratorsCompletedSurgery | Mechanical Ventilation Complication | Pulmonary ComplicationSpain, Germany, Netherlands
-
RenJi HospitalNot yet recruitingPulmonary Complication
-
Min SuNot yet recruitingPulmonary ComplicationChina
-
Seoul National University HospitalRecruitingPulmonary ComplicationKorea, Republic of
-
Seoul National University HospitalCompletedPulmonary ComplicationKorea, Republic of
-
Seoul National University Bundang HospitalRecruitingPostoperative Pulmonary ComplicationKorea, Republic of
-
Qin ZhangCompletedCardiac Surgery | Pulmonary ComplicationChina
-
University of BaghdadActive, not recruitingPost Opeative Pulmonary ComplicationIraq
-
Institut Cancerologie de l'OuestDirection Générale de l'Offre de SoinsCompletedPulmonary Complication | Surgical PatientsFrance
Clinical Trials on respiratory exercise diary
-
Marmara UniversityCompletedCardiovascular SurgeryTurkey
-
Oliver FaudeCompletedSarcopenia | Aging | Cognitive Decline | Age-Related Loss of Skeletal Muscle MassSwitzerland
-
University Health Network, TorontoUnknown
-
Michigan State UniversityKenyan Diabetes Management & Information Centre (DMI)CompletedType 1 DiabetesKenya
-
National Cheng-Kung University HospitalRecruiting
-
Augusta UniversityRecruitingConstipation | Diarrhea | Bloating | Distension | GasUnited States
-
Augusta UniversityRecruiting
-
Unidade Local de Saúde de Matosinhos, EPERecruitingMigraine Disorders | Episodic MigrainePortugal
-
Yeditepe UniversityBahçeşehir UniversityCompleted
-
Okan UniversityCompletedCOPD | Pulmonary Function | Soft Tissue MobilizationTurkey