NCT07665593

Brief Summary

This randomized controlled study aims to evaluate the effect of artificial intelligence (AI)-assisted respiratory training on fatigue, pain, and respiratory parameters in patients after open heart surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress74%
Feb 2026Oct 2026

Study Start

First participant enrolled

February 10, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 13, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

painnursing carefatiguebreathing exercisesopen heart surgery

Outcome Measures

Primary Outcomes (5)

  • Change in Respiratory Rate

    Measured continuously as breaths per minute while the patient is at rest.

    Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Change in Oxygen Saturation (SpO2)

    Measured as a percentage (%) using a noninvasive pulse oximeter

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Change in Heart Rate

    Measured as beats per minute at rest using a noninvasive patient monitor.

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Pain Level

    Evaluated using the self-reported Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where "0" indicates no pain and "10" indicates unbearable pain. Higher scores mean a worse outcome.

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Fatigue Level

    Evaluated using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where "0" indicates no fatigue and "10" indicates unbearable fatigue. Higher scores represent increased fatigue.

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

Secondary Outcomes (3)

  • Dyspnea Level

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Chest Tube Drainage Level

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).

  • Presence of Chest Tube Tidaling

    Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)

Study Arms (3)

Rhythmic Breathing Group

EXPERIMENTAL

Patients will watch an AI-generated video via tablet and simultaneously perform a 3x3x3 rhythmic breathing exercise, which consists of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be repeated 5 times per session, once a day, for 3 days.

Other: Rhythmic Breathing Group

Range of Motion-Deep Breathing (ROM-DN) Group

EXPERIMENTAL

Patients will watch an AI-generated video via tablet and simultaneously perform upper extremity Range of Motion (ROM) exercises combined with deep breathing. The exercise consists of 5 sets of controlled inspiration and expiration synchronized with arm abduction and adduction. This will be applied once a day for 3 days.

Other: Range of Motion-Deep Breathing (ROM-DN) Group

Control Group

NO INTERVENTION

Patients in this group will not receive the study-specific video exercises. They will be monitored under the clinic's standard routine care protocol, which includes standard breathing exercises and the use of an incentive spirometer (triflo).

Interventions

Patients in this group will watch an artificial intelligence-generated educational video on a tablet. Following the visual and auditory instructions in the video, they will perform a rhythmic breathing exercise consisting of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.

Rhythmic Breathing Group

Patients in this group will watch an artificial intelligence-generated educational video on a tablet. They will perform upper extremity range of motion (abduction and adduction) exercises synchronized with deep inspiration and expiration. This exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.

Range of Motion-Deep Breathing (ROM-DN) Group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective open heart surgery.
  • Conscious.
  • Speaks and understands Turkish.
  • Has a chest tube inserted (on the right and/or left side).
  • No visual, auditory, or mental problems.
  • Willing to participate in the study.

You may not qualify if:

  • Undergoing concurrent other chest surgery or having a history of re-surgery.
  • Development of early postoperative complications (e.g., atelectasis) within 0-3 days.
  • Any loss of an extremity.
  • Long-term immobilization and intubation.
  • Development of severe post-surgery infections (such as mediastinitis or sepsis) or respiratory complications (such as pneumonia or atelectasis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, 41380, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainFatigue

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Yaren Yurdakul, BSC

    Kocaeli University

    PRINCIPAL INVESTIGATOR
  • Yasemin Özhanlı, PHD

    Kocaeli University

    STUDY CHAIR

Central Study Contacts

Yasemin Özhanlı, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 24, 2026

Study Start

February 10, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations