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

Pain Clinical Trial

— Virtual  

Official title:

The Effect of Virtual Reality Glasses Applied on Chest Tube Removal After Open Heart Surgery on Pain Level and Hemodynamic Variables

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05585853
• Other study ID #: MersinUnii
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2023
• Source: Mersin University
• Contact: Tugba CAM YANIK, PhD
• Phone: +90 324 361 00 01
• Email: tugbacam[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, between 15 November 2022 - 15 November 2023, 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Turkey, Mersin University,	Mersin	Turkey/Mersin,Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluated using the Visual Analogue Scale	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.)	Change from before implementation up to 30 minutes
Secondary	Systolic blood pressure	Systolic blood pressure (SBP), mmHg	Change from before implementation up to 30 minutes
Secondary	Diastolic blood pressure	Diastolic blood pressure (DBP), mmHg	Change from before implementation up to 30 minutes
Secondary	Heart rate	Beats per minute	Change from before implementation up to 30 minutes
Secondary	Respiratory rate	Lung breathing	Change from before implementation up to 30 minutes
Secondary	Peripheral oxygen saturation	%, percentage of oxygenated hemoglobin in peripheral arterial blood	Change from before implementation up to 30 minutes