- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918600
Exercises for Early Mobilization of Patients Undergoing Open Heart Surgery With Virtual Reality Application
The Effect of Exercises for Early Mobilization With Virtual Reality Application on Patients Undergoing Open Heart Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yakup akyüz akyüz, research assistant
- Phone Number: +905453355654 +905453355654
- Email: yakup.akyuz@istanbul.edu.tr
Study Contact Backup
- Name: aylin durmaz edeer edeer durmaz edeer, associate professor doctor
- Phone Number: +90 505 747 59 +90 505 747 59 90
- Email: aylin.durmaz@deu.edu.tr
Study Locations
-
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Türkiye
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Istanbul, Türkiye, Turkey, 34093
- Istanbul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who voluntarily agreed to participate in the study and written consent was obtained,
- 18 years and over,
- Literate,
- Understand and speak Turkish language,
- No sensory problem (auditory, visual)
- Person, place and time oriented,
- No cognitive problems in expressing themselves,
- Does not have any physical limitation (disability),
- Patients undergoing planned open heart surgery for the first time
Exclusion Criteria:
- Patients with neurological problems (stroke, etc.),
- Patients who develop complications related to surgery in the clinic (delirium, arterial fibrillation, sternal angulation, etc.),
- History of cerebrovascular events,
- Patients with a Glasgow scale <15,
- Patients with complaints of vertigo, dizziness, etc.
- Patients with impaired hemodynamics when wearing glasses
- Deterioration of the general condition of the patient
- Patient abandonment of the study
- Death of the patient
- Patients who develop nausea and vomiting while wearing virtual reality glasses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group: Virtual Reality-Supported Early Mobilization Exercises
Participants in this group will use a virtual reality (VR) application designed to support early mobilization after open-heart surgery.
The VR application includes guided breathing exercises, lower limb movements, and structured mobilization strategies.
These sessions will be conducted using a VR headset, with supervision from a healthcare professional to ensure safety and correct execution.
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The intervention involves the use of a virtual reality (VR)-supported mobilization program specifically designed for patients recovering from open-heart surgery. Participants wear a VR headset that delivers guided sessions comprising: Breathing Exercises: Deep breathing and coughing techniques to support respiratory function and prevent complications. Lower Limb Exercises: Interactive movements aimed at improving circulation and preventing venous stasis. Mobilization Strategies: Gradual and guided steps to assist patients in transitioning from bed to ambulation, tailored to their recovery stage. This intervention is unique because it integrates an immersive and engaging digital environment to promote physical activity, reduce anxiety, and enhance motivation during the critical early postoperative phase. Unlike standard rehabilitation practices, the VR program provides real-time feedback and visual cues to ensure correct execution of movements.
Other Names:
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No Intervention: Control Group: Standard Postoperative Care and Mobilization
Participants in this group will receive standard postoperative care, including mobilization practices routinely implemented in the clinical setting.
This involves assisted physical activity, such as walking and light exercises, guided by the clinical team.
No VR intervention will be applied to this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure: Changes in mobility levels
Time Frame: 1 DAY
|
Description: Evaluated using the Patient Mobility Scale to assess patients' ability to perform activities such as sitting, standing, and walking during the early postoperative period.
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1 DAY
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yakup akyüz, research assistant, istanbul university faculty of nursing department of surgical diseases nursing
Publications and helpful links
General Publications
- Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.
- Bruno RR, Vlake JH, Molina CA, Aubin H. Editorial: Virtual reality in acute cardiovascular care. Front Cardiovasc Med. 2024 Nov 5;11:1504019. doi: 10.3389/fcvm.2024.1504019. eCollection 2024. No abstract available.
- Samant S, Bakhos JJ, Wu W, Zhao S, Kassab GS, Khan B, Panagopoulos A, Makadia J, Oguz UM, Banga A, Fayaz M, Glass W, Chiastra C, Burzotta F, LaDisa JF Jr, Iaizzo P, Murasato Y, Dubini G, Migliavacca F, Mickley T, Bicek A, Fontana J, West NEJ, Mortier P, Boyers PJ, Gold JP, Anderson DR, Tcheng JE, Windle JR, Samady H, Jaffer FA, Desai NR, Lansky A, Mena-Hurtado C, Abbott D, Brilakis ES, Lassen JF, Louvard Y, Stankovic G, Serruys PW, Velazquez E, Elias P, Bhatt DL, Dangas G, Chatzizisis YS. Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions. JACC Cardiovasc Interv. 2023 Oct 23;16(20):2479-2497. doi: 10.1016/j.jcin.2023.07.022.
- Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.
- Mendez KJW, Piasecki RJ, Hudson K, Renda S, Mollenkopf N, Nettles BS, Han HR. Virtual and augmented reality: Implications for the future of nursing education. Nurse Educ Today. 2020 Oct;93:104531. doi: 10.1016/j.nedt.2020.104531. Epub 2020 Jul 7. No abstract available.
- Chen FQ, Leng YF, Ge JF, Wang DW, Li C, Chen B, Sun ZL. Effectiveness of Virtual Reality in Nursing Education: Meta-Analysis. J Med Internet Res. 2020 Sep 15;22(9):e18290. doi: 10.2196/18290.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- İstanbulU/2025/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The following Individual Participant Data (IPD) will be shared as part of this study:
De-identified Participant Data:
Demographic and baseline characteristics (age, gender, clinical history). Outcome measures, including mobility scores, pain levels (VAS), kinesiophobia scores (Tampa Scale), walking distance, and step count.
Length of hospital stay.
Data Types:
Primary and secondary outcome data collected during the intervention period.
Exclusions:
No personally identifiable information (e.g., names, hospital IDs) will be shared to ensure confidentiality.
Data Format:
Data will be shared in anonymized datasets suitable for statistical analysis (e.g., CSV or Excel format).
This data will be made available to researchers upon request and approval, solely for academic purposes, and in accordance with ethical guidelines and data-sharing agreements.
IPD Sharing Time Frame
Start Date: Data will be available starting 6 months after the publication of study results.
End Date: Data access will remain open for 5 years following the start date. This time frame ensures adequate time for data curation and compliance with ethical and legal guidelines while allowing ample opportunity for secondary research.
IPD Sharing Access Criteria
Who Can Access:
Researchers affiliated with academic, non-profit, or healthcare institutions. Individuals conducting studies for non-commercial purposes.
What Can Be Accessed:
De-identified participant-level data, including baseline characteristics and outcome measures.
Study protocol, statistical analysis plan, and informed consent templates.
How to Access:
Researchers must submit a formal data request, including a research proposal, study objectives, and intended use of the data.
Requests should be directed to the corresponding author or principal investigator via the designated contact email.
A data-sharing agreement will be required to ensure ethical use, confidentiality, and compliance with applicable regulations.
Conditions:
Access will only be granted for projects aligned with the original study objectives or for advancing related scientific knowledge.
Data must not be shared with third parties or used for commercial purposes. Acknowledgment of the original study in any resu
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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