NCT06507163

Brief Summary

It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 6, 2024

Last Update Submit

July 11, 2024

Conditions

Breathing ExercisesCardiac SurgeryIncentive Spirometry

Outcome Measures

Primary Outcomes (5)

  • Pain level

    Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.

    postop 1st and postop 5th day

  • Anxiety level

    Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10.

    postop 1st and postop 5th day

  • Comfort level

    It was evaluated with the General Comfort Scale. The scale is a four-point Likert type and contains a total of 48 items.

    postop 1st and postop 5th day

  • Partial oxygen pressure (PaO2)

    It is evaluated with a sample taken from arterial blood.

    postop 1st and postop 5th day

  • Forced Vital Capacity (FVC)

    It is measured with a device called spirometer.

    postop 5th day

Study Arms (3)

The post-surgical breathing exercise group

EXPERIMENTAL

Individuals in this group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for 5 days in the postoperative period.

Other: The post-surgical breathing exercise group

The pre- and post- surgical breathing exercise group

EXPERIMENTAL

Individuals in this group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period.

Other: The pre- and post- surgical breathing exercise group

Control group

NO INTERVENTION

Routine practice group

Interventions

The post-surgical breathing exercise groupOTHER

Individuals in the Intervention-1 group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for 5 days in the postoperative period.

Also known as: Intervention-1 group
The post-surgical breathing exercise group
The pre- and post- surgical breathing exercise groupOTHER

Individuals in the Intervention-2 group were asked to perform 10 breathing exercises with IS every waking hour in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period.

Also known as: Intervention-2 group
The pre- and post- surgical breathing exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to communicate in Turkish,
  • undergoing cardiac surgery,
  • no pain in the preoperative period (0 pain according to VA),
  • have no problems with vision, hearing or speech,
  • individuals who agreed to participate in the study were included.

You may not qualify if:

  • Using psychiatric medication,
  • Using immunosuppressive medication until 30 days before surgery,
  • with neuromuscular disorders,
  • having rheumatic disease,
  • have had pulmonary surgery before,
  • with cerebrovascular injury,
  • diagnosed with cardiovascular instability or aneurysm,
  • Diagnosed with COPD,
  • individuals who do not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevda Korkut

Talas, Kayseri, 0(553) 310 49 51, Turkey (Türkiye)

Location

Study Officials

  • SEVDA KORKUT

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

July 6, 2024

First Posted

July 18, 2024

Study Start

May 3, 2023

Primary Completion

January 14, 2024

Study Completion

January 14, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)