The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia

The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia: A Randomised Controlled Study

This study will be carried out in patients undergoing spinal anaesthesia. The effects of virtual reality and music playback on anxiety and agitation in patients will be evaluated.

Study Overview

• Status: Completed
• Conditions: Surgery; Anxiety State; Spinal Anaesthesia; Ajitation
• Intervention / Treatment: Other: displaying virtual reality images; Other: music playback

Detailed Description

Virtual reality is a computer technology in which a virtual environment is simulated in three dimensions. This technology isolates the individual from real life by zooming the lenses to the patient's eyes through a headset known as virtual reality glasses. Recently, with technological developments, virtual reality applications have started to take place among nursing practices as non-pharmacological approaches that support pharmacological methods in clinical settings. Various studies have revealed that virtual reality as a distraction method plays an important role in alleviating anxiety and agitation experienced by patients.

Music application is an easy-to-apply and non-invasive non-pharmacological method. Music recitals give a feeling of relaxation by increasing the release of endorphin hormone in individuals and play an important role as a psychosocial intervention. Such activities reduce symptoms of anxiety and depression, improve quality of life and have positive effects on physical symptoms and general well-being. In addition, the effects of music on respiratory rate, blood pressure and heart rate are also observed.

This study aims to evaluate the effects of virtual reality technology and music playback on anxiety, agitation and physiological parameters in patients undergoing spinal anaesthesia and to make important contributions to the literature in this context.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kars, Turkey, 36100
    • Kars Harakani State Hospital Operating Theatre Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older,
• Clear consciousness, able to communicate,
• No hearing-speech problems,
• Who volunteered to participate in the study,
• Patients who would undergo Urology, General Surgery, Orthopedics, Cardiovascular Surgery, Neurosurgery by spinal anaesthesia were included in the study.

Exclusion Criteria:

• Patients without spinal anaesthesia,
• Patients who participated in the study but voluntarily withdrew at any stage of the study or patients who had to withdraw involuntarily during the operation were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality glasses; Patients were shown walking in the forest, underwater life, nature landscapes and snow landscapes with virtual reality goggles.	Other: displaying virtual reality images; Patients were shown content filmed in 4K resolution through the glasses.; Other Names: VR
Experimental: music; Music was played to the patients with headphones.	Other: music playback; With the permission of the Turkish Music Research and Promotion Group (TÜMATA), 'Acemaşiran Makamı' was played.
No Intervention: control; Patients in the normal operation process, no intervention was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Anaesthesia Anxiety and Agitation Scale	to evaluate anxiety and agitation in individuals under spinal anaesthesia. Spinal Anaesthesia Anxiety Scale consists of two sub-dimensions called 'Intellectual Experience' and 'Sensory Experience' and 14 questions. The Sensory Experience sub-dimension includes eight questions and the Intellectual Experience sub-dimension includes six questions. The Spinal Anaesthesia Anxiety Scale is a 5-point Likert-type scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree). Spinal Anaesthesia Agitation Scale consisted of 9 questions and three sub-dimensions as 'Verbal Non-Aggressive Behaviours', 'Aggressive Behaviours towards Personnel' and 'Aggressive Behaviours towards Self'.	1 year

Collaborators and Investigators

• Sponsor: Kafkas University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; spinal anaesthesia; patient
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KAFKASSERDAGIORAL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No