Clinical trial NCT06918600: Exercises for Early Mobilization of Patients Undergoing Open Heart Surgery With Virtual Reality Application
Official title: The Effect of Exercises for Early Mobilization With Virtual Reality Application on Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Mobilization, Open-heart Surgery, Virtual Reality
Keywords: virtual reality, open heart surgery, early mobilization, nursing, surgery, postoperative care
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a randomized controlled trial (RCT) design to evaluate the effects of virtual reality (VR) applications on early mobilization in patients who have undergone open-heart surgery. The interventional model involves two groups: Intervention Group: Participants in this group will use VR technology to engage in guided mobilization exercises. VR applications will provide structured, engaging, and interactive sessions designed to enhance physical activity and recovery. Each session includes a combination of breathing exercises, lower limb movements, and mobilization strategies presented through a user-friendly VR interface. Control Group: Participants in the control group will receive standard post-operative care, including mobilization as routinely practiced in the clinical setting. No VR application will be used in this group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of virtual reality (VR) applications in promoting early mobilization exercises for patients undergoing open-heart surgery. Virtual reality is a non-invasive, easily accessible, and innovative method increasingly used in healthcare settings, including rehabilitation and exercise interventions. Evidence from the literature highlights VR's potential to reduce anxiety, and improve recovery in various patient groups. Despite its extensive applications, there is limited research on the impact of VR in the early postoperative care of cardiac surgery patients. This study addresses this gap by investigating the role of VR-based exercises in improving physical activity and rehabilitation outcomes during the critical early recovery period after surgery. Participants will engage in a VR-supported rehabilitation program during their hospital stay. The study will assess the effects of VR exercises on early mobilization, and overall recovery. The results aim to contribute to the growing field of digital health and provide evidence for integrating VR into postoperative care to enhance the quality of nursing care and patient outcomes.

Detailed description: This study investigates the effectiveness of virtual reality (VR) applications in supporting early mobilization exercises for patients undergoing open-heart surgery. The intervention leverages VR technology as a non-invasive, accessible, and engaging tool to enhance recovery outcomes in the critical early postoperative period. While VR has been widely used in rehabilitation for various patient populations, its application in cardiac surgery for early mobilization remains limited and underexplored. Using a randomized controlled trial design, this research evaluates the impact of VR-based exercises compared to standard care on patients' physical activity, motivation, and recovery. The intervention focuses on promoting physical mobility through interactive VR modules designed to facilitate rehabilitation exercises in a hospital setting. Additionally, the study examines the psychological and social benefits of VR, including its potential to reduce anxiety and improve emotional well-being during the recovery process. This research aims to address a gap in the literature by focusing on the early postoperative phase, where effective mobilization is critical to preventing complications and promoting faster recovery. The study is aligned with the Republic of Turkey's 12th Development Plan, emphasizing the integration of digital health technologies into routine healthcare services to improve patient outcomes and quality of care. The findings from this study are expected to provide valuable evidence supporting the adoption of VR in postoperative care for open-heart surgery patients. By demonstrating its effectiveness as a cost-efficient and scalable intervention, this research seeks to contribute to the development of innovative and patient-centered approaches in nursing care and digital health practices.

Eligibility criteria: 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

Primary outcomes:
measure: Measure: Changes in mobility levels
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Türkiye
Study officials:
affiliation: istanbul university faculty of nursing department of surgical diseases nursing
name: yakup akyüz, research assistant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.