AllergyNCT06479967
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs
A study testing The VR glasses group and the music group in people with Allergy and Anxiety, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation. Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- What is being tested?
- The VR glasses group and the music group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2022to 15 Dec 2023
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-12 undergoing their initial skin test
- With no cognitive, visual, or auditory impairments
- No recent medical encounters involving pain or anxiety within the past 3 months
- Parents who volunteered for participation in this study.
Who cannot join
- Those who are not between the ages of 9 and 12 and have had a skin prick test before
- With cognitive, visual, or auditory impairments,
- Recent medical encounters involving pain or anxiety within the past 3 months,
- Parents who volunteered no for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial
Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
Read the detailed description
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
Key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.
- Conditions
- Allergy, Anxiety, Pain, Itching, Vital Signs
- Being tested
- The VR glasses group, the music group
- Keywords
- allergy, skin test, children, itching, musictherapy, Pain, Anxiety, Virtual Reality
- Medical subject headings
- Hypersensitivity, Anxiety Disorders, Pain, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VR glasses groupOther
The Virtual Reality glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon
the music groupOther
The music group listened to classical piano \"The Best of Chopin.\" After the music group took a 1-minute break from listening to music, and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The Virtual Reality glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon Receives: Other: The VR glasses group |
| Music | Experimental | The music group listened to classical piano "The Best of Chopin."
After the music group took a 1-minute break from listening to music, and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10. Receives: Other: the music group |
| Control | No intervention | Before, during, and after the skin prick test evaluation (15 minutes), no intervention was provided to the children assigned to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)
Measured: 12 week
Pain Levels
Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10")
Measured: 12 week
Itching level
Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10
Measured: 12 week
Heart Rate
Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110.
Measured: 12 weeks
Oxygen Saturation
Oxygen Saturation. ( between % 95-100)
Measured: 12 week
Respiratory Rate
Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start12 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA UNAL, Uludag University
- Investigators
- Eda UNAL, PhD, Principal investigator, Uludag universtyAysel OZDEMIR, PhD, Study director, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479967
- Sponsor's protocol ID
- EU13021985
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Publications
Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.
PubMed 34036696da Silva Santa IN, Schveitzer MC, Dos Santos MLBM, Ghelman R, Filho VO. MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102725. doi: 10.1016/j.ctim.2021.102725. Epub 2021 May 5.
PubMed 33964406Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.
PubMed 31838780Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.
PubMed 24943088
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06479967
- Acronym / sponsor ID
- EU13021985
- Conditions
- Allergy, Anxiety, Pain, Itching, Vital Signs
- Keywords
- allergy, skin test, children, itching, musictherapy, Pain, Anxiety, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 28 Jun 2024 (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.
Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
Detailed description
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
Key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: The VR glasses groupThe Virtual Reality glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon |
| Music | Experimental | Other: the music groupThe music group listened to classical piano "The Best of Chopin." After the music group took a 1-minute break from listening to music, and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10. |
| Control | No intervention | –Before, during, and after the skin prick test evaluation (15 minutes), no intervention was provided to the children assigned to the control group. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 9-12 undergoing their initial skin test
- With no cognitive, visual, or auditory impairments
- No recent medical encounters involving pain or anxiety within the past 3 months
- Parents who volunteered for participation in this study.
Key exclusion criteria (4 listed)
- Those who are not between the ages of 9 and 12 and have had a skin prick test before
- With cognitive, visual, or auditory impairments,
- Recent medical encounters involving pain or anxiety within the past 3 months,
- Parents who volunteered no for participation in this 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 |
|---|---|---|
| The VR glasses groupThe Virtual Reality glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon | Other | Virtual Reality |
| the music groupThe music group listened to classical piano \"The Best of Chopin.\" After the music group took a 1-minute break from listening to music, and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10. | Other | Music |
Primary outcome
Anxiety level
Time frame: 12 week
State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)
Pain Levels
Time frame: 12 week
Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10")
Itching level
Time frame: 12 week
Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10
Heart Rate
Time frame: 12 weeks
Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110.
Oxygen Saturation
Time frame: 12 week
Oxygen Saturation. ( between % 95-100)
Respiratory Rate
Time frame: 12 weeks
Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute
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 1 Jul 2024.
- Background: PubMed 34036696Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.
- Background: PubMed 33964406da Silva Santa IN, Schveitzer MC, Dos Santos MLBM, Ghelman R, Filho VO. MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102725. doi: 10.1016/j.ctim.2021.102725. Epub 2021 May 5.
- Background: PubMed 31838780Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.
- Background: PubMed 24943088Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.
- Individual participant dataSharing planned: No. No.
Related trials for Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Eda UNAL, PhD principal investigator
Uludag universty
Aysel OZDEMIR, PhD study director
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The VR glasses group and the music group in people with Allergy and Anxiety, run by Uludag 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 4 inclusion and 4 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 1 Jul 2024. 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?
Anxiety level (time frame: 12 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479967, which also lists 4 linked publications.
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 1 Jul 2024.