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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Erdoğan Mütevelli Sözüer, Prof.
  • Phone Number: 21603 +90 352 207 6666
  • Email: esozuer@erciyes.edu.tr

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: respiratory 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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