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Completed

NCT Number: NCT06765967

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kars Harakani State Hospital Operating Theatre Unit

Kars, 36100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

displaying virtual reality images

Other

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

Other names: VR

music playback

Other

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

Primary outcomes

  1. Spinal Anaesthesia Anxiety and Agitation Scale

    Time frame: 1 year

    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'.

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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