NCT07109934

Brief Summary

This study compares the effects of incentive spirometry and chest mobilization on oxygenation and chest expansion in patients after upper abdominal surgery. It is a randomized clinical trial that aims to determine which intervention more effectively improves respiratory function. The findings likely reveal that both methods positively impact lung expansion and oxygenation, but one may be superior in enhancing recovery and preventing postoperative pulmonary complications.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

July 23, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

upper abdominal surgeryIncentive spirometryDeep breathingChest expansion

Outcome Measures

Primary Outcomes (2)

  • Tape measuring

    • Tape measuring is extensively employed in to assess chest expansion, participants are directed to complete a maximal inhale and exhale, as it is a straightforward and easily detectable movement of the chest. The extent of chest expansion is determined by subtracting the thoracic circumference at the conclusion of forced inspiration from the thoracic circumference at the conclusion of forced expiration

    6 time point at which the measurement is assessed for both study and control groups divided in to tow days, 3 times per day as following after 1 hours , after 8 hours and after 16 hours

  • Physiological Evaluation:

    \- Pulse oximetry, sometimes known as the fifth vital sign, is a rapid and non-invasive monitoring method that measures the oxygen saturation in the blood by directing visible light at particular wavelengths through tissue, typically the fingernail bed. This pulse oximeter comprises a peripheral probe and a microprocessor unit that presents a waveform, the computed oxygen saturation percentage, and the average pulse rate. Available alarms are triggered by a low SpO2 level or a pulse rate that is either tachycardia or bradycardic.

    6 time point at which the measurement is assessed for both study and control groups divided in to tow days, 3 times per day as following after 1 hours , after 8 hours and after 16 hours

Study Arms (2)

deep breathing exercises, chest mobilization:

EXPERIMENTAL

The first group received a breathing exercise 2 hours after the surgery while they were completely conscious. The patients were instructed to engage in deep and gentle inspired breathing, maintain it for 3 seconds, and then exhale gently via the mouth while seated in a semi-sitting posture. During expiration, the patients were instructed to cough twice with maximum efficiency (patients were instructed to maintain a cushion in the incision area during coughing). Thereafter, the patient was provided with an incentive spirometer to be utilized 5 to 10 times daily at intervals of 2 hours. The chest mobilization was conducted five times each set, with three sets assigned to each session Individual participants independently performed chest mobilization under the guidance of a physiotherapist for the first time. The chest mobilization technique involves pulling the arms upwards to their maximum extent while inhaling appropriately during arm movement.

Device: deep breathing exercises, chest mobilization:

2. deep breathing exercises, incentive spirometry: the second group was received usual routine hospi

NO INTERVENTION

Interventions

The patients were instructed to engage in deep and gentle inspired breathing, maintain it for 3 seconds, and then exhale gently via the mouth while seated in a semi-sitting posture. During expiration, the patients were instructed to cough twice with maximum efficiency (patients were instructed to maintain a cushion in the incision area during coughing). Thereafter, the patient was provided with an incentive spirometer to be utilized 5 to 10 times daily at intervals of 2 hours. The chest mobilization was conducted five times each set, with three sets assigned to each session Individual participants independently performed chest mobilization under the guidance of a physiotherapist for the first time. The chest mobilization technique involves pulling the arms upwards to their maximum extent while inhaling appropriately during arm movement.

deep breathing exercises, chest mobilization:

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult aged 18\> 60 years
  • posted for upper abdominal surgery.
  • Accepted to participate in the study

You may not qualify if:

  • Patients exhibiting unstable hemodynamic parameters characterized by arterial pressure below 100 mmHg systolic and below 60 mmHg diastolic, and mean arterial pressure (MAP) below 80 mmHg.
  • Surgical patients experiencing postoperative problems needing mechanical ventilation.
  • Uncooperative patients or individuals with limited comprehension or inability to proficiently operate the gadget .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AL-Kindi teaching hospital

Baghdad, 61001, Iraq

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The sample will be chosen from the patients undergoing upper abdominal surgery at the Hospital using a simple random selection procedure. The technique of simple random sampling is extensively employed in quantitative research using survey instruments. The viability of simple random sampling in homogeneous and uniformly selected groups is demonstrated. This selection strategy ensures that all individuals have an equal chance to participate in the study, with the selection procedure being completely determined by chance
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
instructor

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 7, 2025

Study Start

January 22, 2025

Primary Completion

February 22, 2026

Study Completion

April 22, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations