Heart; Surgery, Heart, Functional Disturbance as ResultNCT06435715
The Effect of 10 Repetitions of Deep Breathing Exercises
A study testing 10 Repetitions of Deep Breathing Exercise and 3 Repetitions of Deep Breathing Exercise in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn and assess the effect of 10 repetitions of deep breathing exercises every 3 hours compared to 3 repetitions of deep breathing exercises on the sleep quality of patients after heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- 10 Repetitions of Deep Breathing Exercise and 3 Repetitions of Deep Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Apr 2024to 20 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone cardiac surgery, both on-pump and off-pump.
- The patient's hemodynamic condition is stable.
- More than equal to 18 years old.
- Able to communicate, read and write in Indonesian.
Who cannot join
- Patients who receive sleeping medication or sedative therapy.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Centre Harapan Kita
Jakarta, DKI Jakarta, 11420
About this study
Official title: The Effect of 10 Repetitions of Deep Breathing Exercises Compared to 3 Repetitions of Deep Breathing Exercises on The Sleep Quality of Post-Cardiac Surgery Patients
The goal of this clinical trial is to learn and assess the effect of 10 repetitions of deep breathing exercises every 3 hours compared to 3 repetitions of deep breathing exercises on the sleep quality of patients after heart surgery.
The main questions it aims to answer are:
Read more
How does 10 repetitions of deep breathing exercises every 3 hours affect the sleep quality of patients after heart surgery?
Researchers will compare 10 repetitions of deep breathing exercises every 3 hours to 3 repetitions of deep breathing exercises to see if 10 repetitions of deep breathing exercises every 3 hours work to improve sleep quality.
Participants will:
- Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
- Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
Read the detailed description
- Researchers carried out recruitment when the patient had undergone surgery.
- Researchers determine potential respondents who meet the inclusion criteria.
- Researchers explain to potential respondents the procedures, objectives, benefits and risks of the research being conducted.
- Researchers provide time and opportunity for potential respondents to confirm research procedures.
- The researcher provided an informed consent sheet as a form of respondent's agreement to their involvement in the research.
- Researchers determine respondents for the intervention and control groups.
- Respondents do a pretest. The pretest was administered by administering a sleep characteristics and quality questionnaire.
- Researchers provide education to patients regarding deep breathing exercise procedures.
- Respondents in the intervention group performed deep breathing exercises with 10 repetitions every 3 hours for 3 days. Respondents in the control group did 3 repetitions of deep breathing exercises.
- Respondents are monitored in the implementation process using a monitoring form.
- Respondents who completed the exercise will conduct a post-test assessment.
- Being tested
- 10 Repetitions of Deep Breathing Exercise, 3 Repetitions of Deep Breathing Exercise
- Keywords
- Breathing Exercise, Sleep Quality, Cardiac Surgical Procedures
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Repetitions of Deep Breathing ExerciseOther
Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
3 Repetitions of Deep Breathing ExerciseOther
Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The group that carries out the intervention of the treatment being studied Receives: Other: 10 Repetitions of Deep Breathing Exercise |
| Control Group | Active comparator | The group that did usual care Receives: Other: 3 Repetitions of Deep Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality experienced by patients after undergoing heart surgery
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start29 Apr 2024
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Gilang Pamungkas, Universitas Indonesia
- Investigators
- Indra G Pamungkas, Master, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435715
- Sponsor's protocol ID
- DP.04.03/KEP071/EC027/2024
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.
PubMed 31915624
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 10 Repetitions of Deep Breathing Exercises Compared to 3 Repetitions of Deep Breathing Exercises on The Sleep Quality of Post-Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06435715
- Acronym / sponsor ID
- DP.04.03/KEP071/EC027/2024
- Keywords
- Breathing Exercise, Sleep Quality, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 30 May 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.
The goal of this clinical trial is to learn and assess the effect of 10 repetitions of deep breathing exercises every 3 hours compared to 3 repetitions of deep breathing exercises on the sleep quality of patients after heart surgery.
The main questions it aims to answer are:
How does 10 repetitions of deep breathing exercises every 3 hours affect the sleep quality of patients after heart surgery?
Researchers will compare 10 repetitions of deep breathing exercises every 3 hours to 3 repetitions of deep breathing exercises to see if 10 repetitions of deep breathing exercises every 3 hours work to improve sleep quality.
Participants will:
- Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
- Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
Detailed description
- Researchers carried out recruitment when the patient had undergone surgery.
- Researchers determine potential respondents who meet the inclusion criteria.
- Researchers explain to potential respondents the procedures, objectives, benefits and risks of the research being conducted.
- Researchers provide time and opportunity for potential respondents to confirm research procedures.
- The researcher provided an informed consent sheet as a form of respondent's agreement to their involvement in the research.
- Researchers determine respondents for the intervention and control groups.
- Respondents do a pretest. The pretest was administered by administering a sleep characteristics and quality questionnaire.
- Researchers provide education to patients regarding deep breathing exercise procedures.
- Respondents in the intervention group performed deep breathing exercises with 10 repetitions every 3 hours for 3 days. Respondents in the control group did 3 repetitions of deep breathing exercises.
- Respondents are monitored in the implementation process using a monitoring form.
- Respondents who completed the exercise will conduct a post-test assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: 10 Repetitions of Deep Breathing ExerciseThe group that carries out the intervention of the treatment being studied |
| Control Group | Active comparator | Other: 3 Repetitions of Deep Breathing ExerciseThe group that did usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have undergone cardiac surgery, both on-pump and off-pump.
- The patient's hemodynamic condition is stable.
- More than equal to 18 years old.
- Able to communicate, read and write in Indonesian.
Key exclusion criteria (1 listed)
- Patients who receive sleeping medication or sedative therapy.
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 |
|---|---|---|
| 10 Repetitions of Deep Breathing ExerciseRespondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days. | Other | Intervention Group |
| 3 Repetitions of Deep Breathing ExerciseRespondents in the control group performed 3 repetitions of deep breathing exercises for 3 days. | Other | Control Group |
Primary outcome
Sleep Quality
Time frame: 30 minutes
Sleep quality experienced by patients after undergoing heart surgery
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 30 May 2024.
- Results publication: PubMed 31915624Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.
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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.
Indra G Pamungkas, Master study chair
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 Repetitions of Deep Breathing Exercise and 3 Repetitions of Deep Breathing Exercise in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 1 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 30 May 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 Indonesia. 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?
Sleep Quality (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435715, which also lists 1 linked publication.
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 30 May 2024.