NCT06435715

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

21 days

First QC Date

May 26, 2024

Last Update Submit

May 26, 2024

Conditions

Keywords

Breathing ExerciseSleep QualityCardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Sleep quality experienced by patients after undergoing heart surgery

    30 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The group that carries out the intervention of the treatment being studied

Other: 10 Repetitions of Deep Breathing Exercise

Control Group

ACTIVE COMPARATOR

The group that did usual care

Other: 3 Repetitions of Deep Breathing Exercise

Interventions

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

Intervention Group

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who receive sleeping medication or sedative therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Centre Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related 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;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Indra G Pamungkas, Master

    Indonesia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ns. Indra Gilang Pamungkas, S.Kep., M.Kep

Study Record Dates

First Submitted

May 26, 2024

First Posted

May 30, 2024

Study Start

April 29, 2024

Primary Completion

May 20, 2024

Study Completion

May 20, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations