## Protocol Section
### Identification Module
**NCT ID:** NCT06435715

**Brief Title:** The Effect of 10 Repetitions of Deep Breathing Exercises

**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

#### Organization Study ID Info
**ID:** DP.04.03/KEP071/EC027/2024
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2024-04-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indonesia University

#### Responsible Party

**Investigator Affiliation:** Indonesia University

**Investigator Full Name:** Indra Gilang Pamungkas

**Investigator Title:** Ns. Indra Gilang Pamungkas, S.Kep., M.Kep

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Heart; Surgery, Heart, Functional Disturbance as Result

**Keywords:**

- Breathing Exercise

- Sleep Quality

- Cardiac Surgical Procedures

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The group that carries out the intervention of the treatment being studied

**Intervention Names:**

- Other: 10 Repetitions of Deep Breathing Exercise

**Label:** Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The group that did usual care

**Intervention Names:**

- Other: 3 Repetitions of Deep Breathing Exercise

**Label:** Control Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group

**Description:** Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.

**Name:** 10 Repetitions of Deep Breathing Exercise

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.

**Name:** 3 Repetitions of Deep Breathing Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Sleep quality experienced by patients after undergoing heart surgery

**Measure:** Sleep Quality

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jakarta

**Country:** Indonesia

**Facility:** National Cardiovascular Centre Harapan Kita

**State:** DKI Jakarta

**Zip:** 11420

#### Overall Officials

**Official 1:**

**Affiliation:** Indonesia University

**Name:** Indra G Pamungkas, Master

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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.

**PMID:** 31915624

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Breathing

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

### Misc Info Module

- Version Holder: 2024-05-31
