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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06435715
Other study ID # DP.04.03/KEP071/EC027/2024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date May 20, 2024

Study information

Verified date May 2024
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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: 1. Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days. 2. Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.


Description:

1. Researchers carried out recruitment when the patient had undergone surgery. 2. Researchers determine potential respondents who meet the inclusion criteria. 3. Researchers explain to potential respondents the procedures, objectives, benefits and risks of the research being conducted. 4. Researchers provide time and opportunity for potential respondents to confirm research procedures. 5. The researcher provided an informed consent sheet as a form of respondent's agreement to their involvement in the research. 6. Researchers determine respondents for the intervention and control groups. 7. Respondents do a pretest. The pretest was administered by administering a sleep characteristics and quality questionnaire. 8. Researchers provide education to patients regarding deep breathing exercise procedures. 9. 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. 10. Respondents are monitored in the implementation process using a monitoring form. 11. Respondents who completed the exercise will conduct a post-test assessment.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 20, 2024
Est. primary completion date May 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients who receive sleeping medication or sedative therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
10 Repetitions of Deep Breathing Exercise
Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
3 Repetitions of Deep Breathing Exercise
Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.

Locations

Country Name City State
Indonesia National Cardiovascular Centre Harapan Kita Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Quality Sleep quality experienced by patients after undergoing heart surgery 30 minutes
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