The Effect of Virtual Reality Glasses on Pain Level and Hemo-Dynamic Variables After Open Heart Surgery

NCT ID: NCT05585853

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-08-26

Brief Summary

In this study, between 1 January 2025 - 1 June 2025, who met the inclusion and exclusion criteria, a total of 82 patients who are on the 2nd or 3rd day after the surgery and who are hospitalized in the cardiovascular surgery intensive care clinic will be recruited.

Detailed Description

The patient will be put on virtual reality glasses five minutes before the chest tube is removed. Afterwards, it will continue to be watched while the tube is taken and virtual reality glasses will be watched for another five minutes. Pain level and hemodynamic variables will be checked before, during, and 15 and 30 minutes after virtual reality glasses are watched. The participants in the control group will receive routine treatment and care, and their data will be collected at the same time as those in the study group. Hemodynamic variables will be monitored and recorded on the monitor.

Virtual reality glasses application is a method without any side effects. During the research, any adverse condition (vision problem, nausea, dizziness, etc.) related to the use of virtual glasses will be observed by the researcher. Since virtual reality glasses will be used in another patient after being used on one patient, disinfection will be made in line with the company's recommendations, taking into account the pandemic conditions. Throughout the application, feedback will be received from the patients by the researchers.

Conditions

Pain; Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality application group

Virtual reality glasses (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) compatible with the mobile phone (Lenovo P2a42) with the Android operating system will be worn and the patient will be watched (underwater world, open-air museum tours, beach trips and nature scenes) by patients for an average of 10 minutes during chest tube removal.

Group Type: EXPERIMENTAL

virtual reality

Intervention Type: OTHER

Virtual reality glasses application is a method without any side effects. Patients will be treated for an average of 10 minutes. Data will be collected before, during, immediately after the application, at the 15th and 30th minutes.

Standard of care

Only standard care will be given and no application will be made.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

virtual reality

Virtual reality glasses application is a method without any side effects. Patients will be treated for an average of 10 minutes. Data will be collected before, during, immediately after the application, at the 15th and 30th minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Agreeing to participate in the research (signing the Informed Consent Form),
• Conscious and cooperative,
• Stable hemodynamic status,
• Speaks and understands Turkish,
• Over 18 years old,
• On the 2nd and 3rd day after open heart surgery,
• Having chest tube,
• No sensitivity or trauma in the area (for the study group) where the virtual reality glasses will be applied,
• No active COVID-19 infection,
• Patients without any psychiatric diagnosis

Exclusion Criteria

• Agreeing to participate in the research (signing the Informed Consent Form),
• Not conscious,
• Not cooperative
• Unstable hemodynamic status,
• Speaks and understands Turkish,
• who are under the age of 18,
• On the 0th or 1st day after surgery,
• No chest tube,
• Has sensitivity or trauma in the area (for the study group) where the virtual reality
• Active COVID-19 infection,
• Patients with a psychiatric diagnosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Tugba CAM YANIK

Principal Investigator in the study/ Research Assistant at Surgical Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay ALTUN UĞRAŞ, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Sevban ARSLAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Muaz GÜLŞEN, master

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Firdevs Ebru ÖZDEMİR, master

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

Turkey, Mersin University,

Mersin, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MersinUnii

Identifier Type: -

Identifier Source: org_study_id