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

NCT06765967 | Completed

• 1 other identifier: KAFKASSERDAGIORAL-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anaesthesia; Anxiety State; Surgery; Ajitation

Keywords

spinal anaesthesia; anxiety; patient

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

virtual reality glasses

EXPERIMENTAL

Patients were shown walking in the forest, underwater life, nature landscapes and snow landscapes with virtual reality goggles.

Other: displaying virtual reality images

music

EXPERIMENTAL

Music was played to the patients with headphones.

Other: music playback

control

NO INTERVENTION

Patients in the normal operation process, no intervention was performed.

Interventions

displaying virtual reality images OTHER

Patients were shown content filmed in 4K resolution through the glasses.

Also known as: VR

virtual reality glasses

music playback OTHER

With the permission of the Turkish Music Research and Promotion Group (TÜMATA), 'Acemaşiran Makamı' was played.

music

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kars Harakani State Hospital Operating Theatre Unit

Kars, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor doctor

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: April 15, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)