- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06435715
The Effect of 10 Repetitions of Deep Breathing Exercises
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:
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 11420
- National Cardiovascular Centre Harapan Kita
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
The group that carries out the intervention of the treatment being studied
|
Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
|
|
Active Comparator: Control Group
The group that did usual care
|
Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality
Time Frame: 30 minutes
|
Sleep quality experienced by patients after undergoing heart surgery
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Indra G Pamungkas, Master, Indonesia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP.04.03/KEP071/EC027/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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