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

NCT05585853 | Completed DMC

• 1 other identifier: MersinUnii
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Hemodynamic Instability

Keywords

pain; Virtual reality glasses; open heart surgery; hemodynamic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Systolic blood pressure

  Change from before implementation up to 30 minutes

• Diastolic blood pressure

  Change from before implementation up to 30 minutes

• Heart rate

  Change from before implementation up to 30 minutes

• Respiratory rate

  Change from before implementation up to 30 minutes

• Peripheral oxygen saturation

  Change from before implementation up to 30 minutes

Study Arms (2)

Virtual Reality application group

EXPERIMENTAL

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.

Other: virtual reality

Standard of care

NO INTERVENTION

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

Interventions

virtual reality 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.

Virtual Reality application group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülay ALTUN UĞRAŞ, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

• Sevban ARSLAN, PhD

  Cukurova University

  PRINCIPAL INVESTIGATOR

• Muaz GÜLŞEN, master

  Cukurova University

  PRINCIPAL INVESTIGATOR

• Firdevs Ebru ÖZDEMİR, master

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator in the study/ Research Assistant at Surgical Nursing

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: August 26, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)