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

NCT ID: NCT06765967

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2024-12-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Anaesthesia Anxiety State Surgery Ajitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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virtual reality glasses

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

Group Type EXPERIMENTAL

displaying virtual reality images

Intervention Type OTHER

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

music

Music was played to the patients with headphones.

Group Type EXPERIMENTAL

music playback

Intervention Type OTHER

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

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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displaying virtual reality images

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

Intervention Type OTHER

music playback

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

Intervention Type OTHER

Other Intervention Names

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VR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafkas University

OTHER

Sponsor Role lead

Responsible Party

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Semra ERDAĞI ORAL

associate professor doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kars Harakani State Hospital Operating Theatre Unit

Kars, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAFKASSERDAGIORAL-001

Identifier Type: -

Identifier Source: org_study_id

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