NCT06078644

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

September 27, 2023

Last Update Submit

April 10, 2026

Conditions

Keywords

general surgerybreathing exercisesdyspneafatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-3 days

Secondary Outcomes (7)

  • dyspnea

    1-3 days

  • fatigue

    1-3 days

  • Pulmonary functional capacity

    1-3 days

  • Respiratory rate

    1-3 days

  • Oxygen saturation

    1-3 days

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychoactive drug use
  • Having Alzheimer's or dementia
  • Having chronic respiratory diseases (COPD, asthma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 34754645BACKGROUND
  • 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.

    PMID: 30022901BACKGROUND
  • 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.

    PMID: 14668188BACKGROUND
  • 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.

    PMID: 25939547BACKGROUND

MeSH Terms

Conditions

DyspneaFatigue

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 12, 2023

Study Start

October 9, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations