Clinical trial NCT05585853: The Effect of Virtual Reality Glasses on Pain Level and Hemo-Dynamic Variables After Open Heart Surgery
Official title: The Effect of Virtual Reality Glasses Applied on Chest Tube Removal After Open Heart Surgery on Pain Level and Hemodynamic Variables
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Hemodynamic Instability
Keywords: pain
Virtual reality glasses
open heart surgery
hemodynamic
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain evaluated using the Visual Analogue Scale
timeFrame: Change from before implementation up to 30 minutes
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from before implementation up to 30 minutes
measure: Diastolic blood pressure
timeFrame: Change from before implementation up to 30 minutes
measure: Heart rate
timeFrame: Change from before implementation up to 30 minutes
measure: Respiratory rate
timeFrame: Change from before implementation up to 30 minutes
measure: Peripheral oxygen saturation
timeFrame: Change from before implementation up to 30 minutes
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University,
Study officials:
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Çukurova University
name: Sevban ARSLAN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Çukurova University
name: Muaz GÜLŞEN, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Firdevs Ebru ÖZDEMİR, master
role: PRINCIPAL_INVESTIGATOR
References: