The Effect of Breathing Exercise Applied With Incentive Spirometer

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: Completed
• Conditions: Cardiac Surgery; Breathing Exercises; Incentive Spirometry
• Intervention / Treatment: Other: The post-surgical breathing exercise group; Other: The pre- and post- surgical breathing exercise group

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: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain level	Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.	postop 1st and postop 5th day
Anxiety level	Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.	postop 1st and postop 5th day
Comfort level	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)	It is evaluated with a sample taken from arterial blood.	postop 1st and postop 5th day
Forced Vital Capacity (FVC)	It is measured with a device called spirometer.	postop 5th day

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: SEVDA KORKUT, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): January 14, 2024
• Study Completion (Actual): January 14, 2024

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID 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