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RecruitingNCT07665593Updated Jun 24, 2026

Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery

An interventional study of Rhythmic Breathing Group and Range of Motion-Deep Breathing (ROM-DN) Group in Nursing Care, Pain and Breathing Exercises, sponsored by Kocaeli University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Kocaeli University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Open heart surgery and related procedures (such as sternotomy, cardiopulmonary bypass, and chest tubes) can negatively affect pulmonary functions and cause postoperative pain, fatigue, and limited respiratory muscle function. While standard care involves respiratory exercises, there is insufficient data regarding the combination of upper extremity Range of Motion (ROM) exercises with deep breathing. This study will utilize AI-generated educational videos, created using tools like ChatGPT, Gemini, and Adobe Firefly, to guide patients in performing these exercises safely and correctly. Participants will be randomized into three groups: a Rhythmic Breathing group, a Range of Motion-Deep Breathing (ROM-DB) group, and a Control group. The interventions will be applied for three consecutive days. The study will evaluate outcomes including respiratory rate, oxygen saturation, heart rate, pain levels, fatigue, dyspnea, and chest tube drainage volume.

02

Conditions studied

  • Nursing Care
  • Pain
  • Breathing Exercises
  • Fatigue Recovery

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Keywords

  • pain
  • nursing care
  • fatigue
  • breathing exercises
  • open heart surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
111 participants (estimated)

Study arms

  • Experimental
    Rhythmic Breathing Group

    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

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

    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

  • No intervention
    Control Group

    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

  • OtherRhythmic Breathing Group

    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.

  • OtherRange of Motion-Deep Breathing (ROM-DN) 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.

05

What researchers measure

Primary outcomes

  1. Change in Respiratory Rate

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

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

  2. Change in Oxygen Saturation (SpO2)

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

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

  3. Change in Heart Rate

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

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

  4. 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.

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

  5. 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.

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

Secondary outcomes

  1. Dyspnea Level

    Evaluated using the Modified Borg Scale (CR-10), a category-ratio scale ranging from 0 (nothing at all) to 10. Higher scores indicate higher perceived exertion/dyspnea.

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

  2. Chest Tube Drainage Level

    The fluid level change in the chest tube drainage system, measured in centimeters (cm).

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

  3. Presence of Chest Tube Tidaling

    Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".

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

06

Study locations

1 of 1 sites recruiting
  • Kocaeli University
    Kocaeli, İzmit 41380, Turkey (Türkiye)
    • Yaren Yurdakul, BSC · Contact · yarenyurdakl@gmail.com · +090 553 495 85 21
    • Yasemin Özhanlı, PHD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07665593
Lead sponsor
Kocaeli University
Responsible party
Yaren Yurdakul (Nurse, Kocaeli University) — Principal investigator
First posted
Jun 24, 2026
Start date
Feb 10, 2026
Primary completion
Aug 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Yaren Yurdakul, BSC
Contact
yarenyurdakl@gmail.com
+090 553 495 85 21
Yasemin Özhanlı, PHD
Contact
yaseminozhanli@gmail.com
(0262) 303 47 01
Yaren Yurdakul, BSC
principal investigator · Kocaeli University
Yasemin Özhanlı, PHD
study chair · Kocaeli University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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