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

Not Applicable

Recruiting

• Conditions: Hemodynamic Instability; Pain
• Interventions: Other: virtual reality

• Registration Number: NCT05585853
• Lead Sponsor: Mersin University

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.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2025-01-01
• Primary Completion: 2025-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality application group	virtual reality	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.

Primary Outcome Measures

Name	Time	Method
Pain evaluated using the Visual Analogue Scale	Change from before implementation up to 30 minutes	Visual Analogue Scala has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a safe and easily applicable scale tool generally accepted in the world literature, consists of a 10 cm long line and there are subjective descriptive expressions at both ends of the scale (0 cm = none at all and 10 cm = highest degree.)

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	Change from before implementation up to 30 minutes	Diastolic blood pressure (DBP), mmHg
Heart rate	Change from before implementation up to 30 minutes	Beats per minute
Systolic blood pressure	Change from before implementation up to 30 minutes	Systolic blood pressure (SBP), mmHg
Respiratory rate	Change from before implementation up to 30 minutes	Lung breathing
Peripheral oxygen saturation	Change from before implementation up to 30 minutes	%, percentage of oxygenated hemoglobin in peripheral arterial blood

Trial Locations

Locations (1)

Turkey, Mersin University,; 🇹🇷 Mersin, Turkey