Breathing ExercisesNCT06507163
The Effect of Breathing Exercise Applied With Incentive Spirometer
A study testing The post-surgical breathing exercise group and The pre- and post- surgical breathing exercise group in people with Breathing Exercises and Cardiac Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breathing Exercises, Cardiac Surgery, Incentive Spirometry
- What is being tested?
- The post-surgical breathing exercise group and The pre- and post- surgical breathing exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 14 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- diagnosed with cardiovascular instability or aneurysm,
- Diagnosed with COPD,
- individuals who do not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breathing Exercises, Cardiac Surgery, Incentive Spirometry
- Being tested
- The post-surgical breathing exercise group, The pre- and post- surgical breathing exercise group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The post-surgical breathing exercise groupOther
Also called Intervention-1 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.
The pre- and post- surgical breathing exercise groupOther
Also called Intervention-2 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.
| Study group | Role | What they receive |
|---|---|---|
| The post-surgical breathing exercise group | Experimental | 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. Receives: Other: The post-surgical breathing exercise group |
| The pre- and post- surgical breathing exercise group | Experimental | 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. Receives: Other: The pre- and post- surgical breathing exercise group |
| Control group | No intervention | Routine practice group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
Measured: postop 1st and postop 5th day
Anxiety level
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
Measured: 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.
Measured: postop 1st and postop 5th day
Partial oxygen pressure (PaO2)
It is evaluated with a sample taken from arterial blood.
Measured: postop 1st and postop 5th day
Forced Vital Capacity (FVC)
It is measured with a device called spirometer.
Measured: postop 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start3 May 2023
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- SEVDA KORKUT, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507163
- Sponsor's protocol ID
- 2318
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise Applied With Incentive Spirometer on Pain, Anxiety, Comfort and Physiological Parameters Before and After Surgery in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06507163
- Acronym / sponsor ID
- 2318
- Conditions
- Breathing Exercises, Cardiac Surgery, Incentive Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The post-surgical breathing exercise group | Experimental | Other: The post-surgical breathing exercise groupIndividuals 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. |
| The pre- and post- surgical breathing exercise group | Experimental | Other: The pre- and post- surgical breathing exercise groupIndividuals 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. |
| Control group | No intervention | –Routine practice group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Using psychiatric medication,
- Using immunosuppressive medication until 30 days before surgery,
- with neuromuscular disorders,
- having rheumatic disease,
- have had pulmonary surgery before,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The post-surgical breathing exercise groupAlso: Intervention-1 groupIndividuals 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 | The post-surgical breathing exercise group |
| The pre- and post- surgical breathing exercise groupAlso: Intervention-2 groupIndividuals 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 | The pre- and post- surgical breathing exercise group |
Primary outcome
Pain level
Time frame: postop 1st and postop 5th day
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
Anxiety level
Time frame: postop 1st and postop 5th day
Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.
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.
Partial oxygen pressure (PaO2)
Time frame: postop 1st and postop 5th day
It is evaluated with a sample taken from arterial blood.
Forced Vital Capacity (FVC)
Time frame: postop 5th day
It is measured with a device called spirometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEVDA KORKUT principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The post-surgical breathing exercise group and The pre- and post- surgical breathing exercise group in people with Breathing Exercises and Cardiac Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: postop 1st and postop 5th day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.