Early Mobilization, Open-heart Surgery, Virtual RealityNCT06918600
Exercises for Early Mobilization of Patients Undergoing Open Heart Surgery With Virtual Reality Application
A study testing Virtual Reality-Supported Early Mobilization Program in people with Early Mobilization, Open-heart Surgery, Virtual Reality, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of a virtual reality (VR)-assisted early mobilization exercise program in patients undergoing open-heart surgery. The study was conducted at a single center and included 160 patients randomly assigned to an intervention group (n = 80) or a control group (n = 80). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Mobilization, Open-heart Surgery, Virtual Reality
- What is being tested?
- Virtual Reality-Supported Early Mobilization Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- No cognitive problems in expressing themselves,
- Does not have any physical limitation (disability),
- Patients undergoing planned open heart surgery for the first time
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercises for Early Mobilization With Virtual Reality Application on Patients Undergoing Open Heart Surgery
This randomized controlled trial evaluated the effects of a virtual reality (VR)-assisted early mobilization exercise program in patients undergoing open-heart surgery. The study was conducted at a single center and included 160 patients randomly assigned to an intervention group (n = 80) or a control group (n = 80). Patients in the intervention group received a VR-assisted exercise program incorporating breathing exercises, lower-limb movements, and mobilization guidance in addition to standard postoperative care. Patients in the control group received standard postoperative care and early mobilization without VR assistance. The primary outcome was mobility, assessed using the Patient Mobility Scale during the early postoperative period. Additional assessments included postoperative pain, walking fear, kinesiophobia, perceived difficulty and dependence during mobilization, and step count.
Read the detailed description
This study was conducted as a single-center, parallel-group randomized controlled trial to evaluate the effects of a virtual reality (VR)-assisted early mobilization exercise program in patients undergoing open-heart surgery.
A total of 160 patients were randomly allocated in a 1:1 ratio to either the intervention group (n = 80) or the control group (n = 80). The intervention group received a VR-assisted early mobilization exercise program in addition to standard postoperative care. The VR program incorporated guided breathing exercises, lower-limb exercises, and information on safe mobilization procedures. The intervention was implemented during the early postoperative period under the supervision of healthcare professionals. Patients in the control group received standard postoperative care and early mobilization according to institutional protocols without VR assistance.
The primary outcome was mobility, assessed using the Patient Mobility Scale during the early postoperative period. Additional outcomes included postoperative pain, fear of walking, kinesiophobia, perceived difficulty and dependence during mobilization, and step count.
Due to the nature of the intervention, participants and the investigator administering the VR program could not be blinded to group allocation. However, outcome assessments were performed by an independent assessor who was blinded to group allocation. Statistical analyses were conducted using coded group assignments to maintain blinding during data analysis.
The study aimed to provide evidence regarding the potential contribution of VR-assisted exercises to early postoperative mobilization and recovery in patients undergoing open-heart surgery.
- Being tested
- Virtual Reality-Supported Early Mobilization Program
- Keywords
- virtual reality, open heart surgery, early mobilization, nursing, surgery, postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Supported Early Mobilization ProgramOther
Also called VR Early Mobilization Program, Virtual Rehabilitation Exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Virtual Reality-Supported Early Mobilization Exercises | Experimental | 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. Receives: Other: Virtual Reality-Supported Early Mobilization Program |
| Control Group: Standard Postoperative Care and Mobilization | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Changes in mobility levels
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.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Aug 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Early Mobilization, Open-heart Surgery, Virtual RealityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a single-center, parallel-group randomized controlled trial to evaluate the effects of virtual reality (VR)-assisted early mobilization exercises in patients undergoing open-heart surgery. A total of 160 patients were randomly assigned in a 1:1 ratio to either the intervention group (n = 80) or the control group (n = 80). The intervention group received a VR-assisted early mobilization exercise program in addition to standard postoperative care. The VR program included guided breathing exercises, foot and leg exercises, and information on mobilization procedures and safety principles. The control group received standard postoperative care and early mobilization according to institutional protocols without VR assistance. Outcomes were assessed during the early postoperative mobilization period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yakup Akyüz, Istanbul University
- Investigators
- yakup akyüz, research assistant, Principal investigator, istanbul university faculty of nursing department of surgical diseases nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918600
- Sponsor's protocol ID
- İstanbulU/2025/1
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39563940Samant 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.
PubMed 37879802Chiu 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.
PubMed 37906193Rousseaux 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.
PubMed 34783683Mendez 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.
PubMed 32711132Chen 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.
PubMed 32930664
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercises for Early Mobilization With Virtual Reality Application on Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06918600
- Acronym / sponsor ID
- İstanbulU/2025/1
- Keywords
- virtual reality, open heart surgery, early mobilization, nursing, surgery, postoperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated the effects of a virtual reality (VR)-assisted early mobilization exercise program in patients undergoing open-heart surgery. The study was conducted at a single center and included 160 patients randomly assigned to an intervention group (n = 80) or a control group (n = 80). Patients in the intervention group received a VR-assisted exercise program incorporating breathing exercises, lower-limb movements, and mobilization guidance in addition to standard postoperative care. Patients in the control group received standard postoperative care and early mobilization without VR assistance. The primary outcome was mobility, assessed using the Patient Mobility Scale during the early postoperative period. Additional assessments included postoperative pain, walking fear, kinesiophobia, perceived difficulty and dependence during mobilization, and step count.
Detailed description
This study was conducted as a single-center, parallel-group randomized controlled trial to evaluate the effects of a virtual reality (VR)-assisted early mobilization exercise program in patients undergoing open-heart surgery.
A total of 160 patients were randomly allocated in a 1:1 ratio to either the intervention group (n = 80) or the control group (n = 80). The intervention group received a VR-assisted early mobilization exercise program in addition to standard postoperative care. The VR program incorporated guided breathing exercises, lower-limb exercises, and information on safe mobilization procedures. The intervention was implemented during the early postoperative period under the supervision of healthcare professionals. Patients in the control group received standard postoperative care and early mobilization according to institutional protocols without VR assistance.
The primary outcome was mobility, assessed using the Patient Mobility Scale during the early postoperative period. Additional outcomes included postoperative pain, fear of walking, kinesiophobia, perceived difficulty and dependence during mobilization, and step count.
Due to the nature of the intervention, participants and the investigator administering the VR program could not be blinded to group allocation. However, outcome assessments were performed by an independent assessor who was blinded to group allocation. Statistical analyses were conducted using coded group assignments to maintain blinding during data analysis.
The study aimed to provide evidence regarding the potential contribution of VR-assisted exercises to early postoperative mobilization and recovery in patients undergoing open-heart surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was conducted as a single-center, parallel-group randomized controlled trial to evaluate the effects of virtual reality (VR)-assisted early mobilization exercises in patients undergoing open-heart surgery. A total of 160 patients were randomly assigned in a 1:1 ratio to either the intervention group (n = 80) or the control group (n = 80). The intervention group received a VR-assisted early mobilization exercise program in addition to standard postoperative care. The VR program included guided breathing exercises, foot and leg exercises, and information on mobilization procedures and safety principles. The control group received standard postoperative care and early mobilization according to institutional protocols without VR assistance. Outcomes were assessed during the early postoperative mobilization period.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Virtual Reality-Supported Early Mobilization Exercises | Experimental | Other: Virtual Reality-Supported Early Mobilization ProgramParticipants 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. |
| Control Group: Standard Postoperative Care and Mobilization | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Supported Early Mobilization ProgramAlso: VR Early Mobilization Program, Virtual Rehabilitation ExercisesThe 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 | Intervention Group: Virtual Reality-Supported Early Mobilization Exercises |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 39563940Bruno 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.
- Results publication: PubMed 37879802Samant 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.
- Results publication: PubMed 37906193Chiu 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.
- Results publication: PubMed 34783683Rousseaux 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.
- Results publication: PubMed 32711132Mendez 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.
- Results publication: PubMed 32930664Chen 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yakup akyüz, research assistant principal investigator
istanbul university faculty of nursing department of surgical diseases nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Supported Early Mobilization Program in people with Early Mobilization, Open-heart Surgery, Virtual Reality, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Changes in mobility levels (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918600, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.