The Effect of Breathing Exercise Applied With Incentive Spirometer

July 11, 2024 updated by: Sevda Korkut, TC Erciyes University

The Effect of Breathing Exercise Applied With Incentive Spirometer on Pain, Anxiety, Comfort and Physiological Parameters Before and After Surgery in Cardiac Surgery Patients

It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.

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.

Detailed Description

It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.The study was conducted in three groups. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for 5 days in the postoperative period. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period. Individuals in the control group were given only the routine practice of the clinic.

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.
75

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 Locations

  • Turkey
    • Kayseri
      • Talas, Kayseri, Turkey, 0(553) 310 49 51
        • Sevda Korkut

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:

  • Able to communicate in Turkish,
  • undergoing cardiac surgery,
  • no pain in the preoperative period (0 pain according to VA),
  • have no problems with vision, hearing or speech,
  • individuals who agreed to participate in the study were included.

Exclusion Criteria:

  • Using psychiatric medication,
  • Using immunosuppressive medication until 30 days before surgery,
  • with neuromuscular disorders,
  • having rheumatic disease,
  • have had pulmonary surgery before,
  • with cerebrovascular injury,
  • diagnosed with cardiovascular instability or aneurysm,
  • Diagnosed with COPD,
  • individuals who do not volunteer to participate in the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: The post-surgical breathing exercise group
Individuals in this group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for 5 days in the postoperative period.
Other: The post-surgical breathing exercise group
Individuals in the Intervention-1 group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for 5 days in the postoperative period.
Other Names:
  • Intervention-1 group
Experimental: The pre- and post- surgical breathing exercise group
Individuals in this group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period.
Other: The pre- and post- surgical breathing exercise group
Individuals in the Intervention-2 group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period.
Other Names:
  • Intervention-2 group
No Intervention: Control group
Routine practice group

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
Pain level
Time Frame: postop 1st and postop 5th day
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
postop 1st and postop 5th day
Anxiety level
Time Frame: postop 1st and postop 5th day
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
postop 1st and postop 5th day
Comfort level
Time Frame: postop 1st and postop 5th day
It was evaluated with the General Comfort Scale. The scale is a four-point Likert type and contains a total of 48 items.
postop 1st and postop 5th day
Partial oxygen pressure (PaO2)
Time Frame: postop 1st and postop 5th day
It is evaluated with a sample taken from arterial blood.
postop 1st and postop 5th day
Forced Vital Capacity (FVC)
Time Frame: postop 5th day
It is measured with a device called spirometer.
postop 5th day

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVDA KORKUT, TC Erciyes University

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.
May 3, 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.
January 14, 2024

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.
January 14, 2024

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).
July 6, 2024

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.
July 11, 2024

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.
July 18, 2024

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.
July 18, 2024

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.
July 11, 2024

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.
July 1, 2024

More Information

Terms related to this study

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.
  • 2318

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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