Spinal AnaesthesiaNCT06765967
The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia
A study testing displaying virtual reality images and music playback in people with Spinal Anaesthesia and Anxiety State, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anaesthesia, Anxiety State, Surgery
- What is being tested?
- displaying virtual reality images and music playback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kars Harakani State Hospital Operating Theatre Unit
Kars, 36100
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Anaesthesia, Anxiety State, Surgery, Ajitation
- Being tested
- displaying virtual reality images, music playback
- Keywords
- spinal anaesthesia, anxiety, patient
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
displaying virtual reality imagesOther
Also called VR
Patients were shown content filmed in 4K resolution through the glasses.
music playbackOther
With the permission of the Turkish Music Research and Promotion Group (TÜMATA), 'Acemaşiran Makamı' was played.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality glasses | Experimental | Patients were shown walking in the forest, underwater life, nature landscapes and snow landscapes with virtual reality goggles. Receives: Other: displaying virtual reality images |
| music | Experimental | Music was played to the patients with headphones. Receives: Other: music playback |
| control | No intervention | Patients in the normal operation process, no intervention was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start15 Apr 2023
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra ERDAĞI ORAL, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765967
- Sponsor's protocol ID
- KAFKASSERDAGIORAL-001
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06765967
- Acronym / sponsor ID
- KAFKASSERDAGIORAL-001
- Conditions
- Spinal Anaesthesia, Anxiety State, Surgery, Ajitation
- Keywords
- spinal anaesthesia, anxiety, patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual reality glasses | Experimental | Other: displaying virtual reality imagesPatients were shown walking in the forest, underwater life, nature landscapes and snow landscapes with virtual reality goggles. |
| music | Experimental | Other: music playbackMusic was played to the patients with headphones. |
| control | No intervention | –Patients in the normal operation process, no intervention was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| displaying virtual reality imagesAlso: VRPatients were shown content filmed in 4K resolution through the glasses. | Other | virtual reality glasses |
| music playbackWith the permission of the Turkish Music Research and Promotion Group (TÜMATA), 'Acemaşiran Makamı' was played. | Other | music |
Primary outcome
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'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing displaying virtual reality images and music playback in people with Spinal Anaesthesia and Anxiety State, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Anaesthesia Anxiety and Agitation Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.