AllergyNCT06401408
Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test
An observational study of Allergy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is determine the effect of virtual reality headsets on pain, anxiety, fear and physiological parameters in children aged 4-7 years who undergoing skin prick test. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 1 Apr 2025
- Phase
- Observational
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population of the study will consist of children aged 4-7 years who underwent skin prick test between September 01, 2023 and March 01, 2024 in the Pediatric Allergy Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. In the power analysis (effect size= 1.32 α= 0.05, β= 0.95) performed in GPower 3.1 with the findings of the study by Stassart and Giebels (2022), the sample size was determined as experimental (SGG) group=16 and control group=16. At the end of the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not.
Who may be able to join
- Between the ages of 4-7,
- Does not have a chronic or genetic disease,
- No mental, visual or hearing impairment,
- No analgesics or sedatives were administered at least one hour before the test procedure,
- Both he and his parents are open to communication and cooperation,
- Children who both themselves and their parents volunteer to participate in the research and give verbal and written consent will be included.
Who cannot join
- Those who are outside the 4-7 age range,
- Having a chronic or genetic disease,
- Mentally, visually or hearing impaired,
- Applying analgesics and sedatives at least one hour before the test procedure,
- The child who cannot adapt to virtual reality glasses,
- Both he and his parents do not cooperate,
- Children who neither they nor their parents volunteer to participate in the research and who do not give verbal or written consent will not be included in the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital
Kayseri, Melikgazi, 38050
Kazım Bağcı, +905336573633
About this study
Official title: Effect of Virtual Reality Headsets on Pain, Anxiety, Fear and Physiological Parameters in Children Who Had Skin Prick Test Applied
The goal of this clinical trial is determine the effect of virtual reality headsets on pain, anxiety, fear and physiological parameters in children aged 4-7 years who undergoing skin prick test. The main questions it amis to answer are:
Virtual reality headsets effect on the pain that during the procedure
Virtual reality headsets effect on the anxiety that occurs during the procedure
Virtual reality headsets effect on the fear that occurs during the procedure
Virtual reality headsets effect on physiological parameters (heart rate, blood pressure, respiratory rate) during the procedure
Read the detailed description
Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test (5 minutes before), the Introductory Characteristics Form for Children and Their Families and scales (so that the pain, fear and anxiety scores predicted by the children before the procedure will be measured) will be applied to the children and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be taken. Then, the children will be fitted with an VRH and watched an animated film (approximately 15 minutes long) determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed (5 minutes later), physiological parameters will be taken again and scales (thus measuring the pain, fear and anxiety scores felt by the children during the procedure) will be applied.
Control group application phase:
No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group.
- Conditions
- Allergy
- Keywords
- allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test, the Introductory Characteristics Form for Children and Their Families and scales will be applied to the children and the child's physiological parameters will be taken. Then, the children will be fitted with an VRH and watched an animated film determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed, physiological parameters will be taken again and scales will be applied. | |
| control group | No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale (CFS)
To conduct an initial investigation of the psychometric properties of the Children's Fear Scale (CFS; based on the adult Faces Anxiety Scale) with young school-age children.The Child Fear Scale (CFS) developed by McMurtry et al. is used to assess the fear levels of children aged 4-10 years. In the scale, 5 cartoon face pictures are used. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety". The validity and reliability of the scale was conducted by Ozalp-Gerceker et al. in 2018. The content validity index is 0.89.Support was found for interrater reliability and test retest reliability of the CFS for measuring children's fear during venipuncture.
Measured: 4 weeks
Secondary outcomes (1)
Children's Anxiety Meter-State (CAM-S)
The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit.Put a line on the thermometer showing how much worry or nervousness you feel."When children did not understand this analogy, we used an alternate script that did not explicitly describe a thermometer. Children were asked to "Pretend that all of your worried or nervous feelings are in the very bottom down here. If you are a little bit worried or nervous, the feelings might come up just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line showing how much worry or nervousness you feel."
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start20 Jun 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazım Bagci, TC Erciyes University
- Investigators
- Fulya Tahan, Prof. Dr., Study chair, responsible for medical procedures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401408
- Sponsor's protocol ID
- ERU-NF-KB-01
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
PubMed 24094126Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
PubMed 35068011Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.
PubMed 19769849Barni S, Liccioli G, Sarti L, Giovannini M, Novembre E, Mori F. Immunoglobulin E (IgE)-Mediated Food Allergy in Children: Epidemiology, Pathogenesis, Diagnosis, Prevention, and Management. Medicina (Kaunas). 2020 Mar 4;56(3):111. doi: 10.3390/medicina56030111.
PubMed 32143431Backer V, Nolte H, Pedersen L, Dam N, Harving H. Unawareness and undertreatment of asthma: follow-up in a different geographic area in Denmark. Allergy. 2009 Aug;64(8):1179-84. doi: 10.1111/j.1398-9995.2009.01994.x. Epub 2009 Feb 20.
PubMed 19243364Bodtger U, Jacobsen CR, Poulsen LK, Malling HJ. Long-term repeatability of the skin prick test is high when supported by history or allergen-sensitivity tests: a prospective clinical study. Allergy. 2003 Nov;58(11):1180-6. doi: 10.1046/j.1398-9995.2003.00323.x.
PubMed 14616131Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.
PubMed 30052655Cheng Z, Yu S, Zhang W, Liu X, Shen Y, Weng H. Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2022 Sep 28;9(12):100152. doi: 10.1016/j.apjon.2022.100152. eCollection 2022 Dec.
PubMed 36389624
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Headsets on Pain, Anxiety, Fear and Physiological Parameters in Children Who Had Skin Prick Test Applied
- ClinicalTrials.gov ID
- NCT06401408
- Acronym / sponsor ID
- ERU-NF-KB-01
- Conditions
- Allergy
- Keywords
- allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 6 May 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.
The goal of this clinical trial is determine the effect of virtual reality headsets on pain, anxiety, fear and physiological parameters in children aged 4-7 years who undergoing skin prick test. The main questions it amis to answer are:
Virtual reality headsets effect on the pain that during the procedure
Virtual reality headsets effect on the anxiety that occurs during the procedure
Virtual reality headsets effect on the fear that occurs during the procedure
Virtual reality headsets effect on physiological parameters (heart rate, blood pressure, respiratory rate) during the procedure
Detailed description
Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test (5 minutes before), the Introductory Characteristics Form for Children and Their Families and scales (so that the pain, fear and anxiety scores predicted by the children before the procedure will be measured) will be applied to the children and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be taken. Then, the children will be fitted with an VRH and watched an animated film (approximately 15 minutes long) determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed (5 minutes later), physiological parameters will be taken again and scales (thus measuring the pain, fear and anxiety scores felt by the children during the procedure) will be applied.
Control group application phase:
No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test, the Introductory Characteristics Form for Children and Their Families and scales will be applied to the children and the child's physiological parameters will be taken. Then, the children will be fitted with an VRH and watched an animated film determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed, physiological parameters will be taken again and scales will be applied. |
| control group | – | –No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population of the study will consist of children aged 4-7 years who underwent skin prick test between September 01, 2023 and March 01, 2024 in the Pediatric Allergy Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. In the power analysis (effect size= 1.32 α= 0.05, β= 0.95) performed in GPower 3.1 with the findings of the study by Stassart and Giebels (2022), the sample size was determined as experimental (SGG) group=16 and control group=16. At the end of the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not.
Key inclusion criteria (6 listed)
- Between the ages of 4-7,
- Does not have a chronic or genetic disease,
- No mental, visual or hearing impairment,
- No analgesics or sedatives were administered at least one hour before the test procedure,
- Both he and his parents are open to communication and cooperation,
Key exclusion criteria (7 listed)
- Those who are outside the 4-7 age range,
- Having a chronic or genetic disease,
- Mentally, visually or hearing impaired,
- Applying analgesics and sedatives at least one hour before the test procedure,
- The child who cannot adapt to virtual reality glasses,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Children's Fear Scale (CFS)
Time frame: 4 weeks
To conduct an initial investigation of the psychometric properties of the Children's Fear Scale (CFS; based on the adult Faces Anxiety Scale) with young school-age children.The Child Fear Scale (CFS) developed by McMurtry et al. is used to assess the fear levels of children aged 4-10 years. In the scale, 5 cartoon face pictures are used. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety". The validity and reliability of the scale was conducted by Ozalp-Gerceker et al. in 2018. The content validity index is 0.89.Support was found for interrater reliability and test retest reliability of the CFS for measuring children's fear during venipuncture.
1 secondary outcome
Children's Anxiety Meter-State (CAM-S)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Results publication: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Results publication: PubMed 24094126Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
- Results publication: PubMed 35068011Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
- Results publication: PubMed 19769849Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.
- Results publication: PubMed 32143431Barni S, Liccioli G, Sarti L, Giovannini M, Novembre E, Mori F. Immunoglobulin E (IgE)-Mediated Food Allergy in Children: Epidemiology, Pathogenesis, Diagnosis, Prevention, and Management. Medicina (Kaunas). 2020 Mar 4;56(3):111. doi: 10.3390/medicina56030111.
- Results publication: PubMed 19243364Backer V, Nolte H, Pedersen L, Dam N, Harving H. Unawareness and undertreatment of asthma: follow-up in a different geographic area in Denmark. Allergy. 2009 Aug;64(8):1179-84. doi: 10.1111/j.1398-9995.2009.01994.x. Epub 2009 Feb 20.
- Results publication: PubMed 14616131Bodtger U, Jacobsen CR, Poulsen LK, Malling HJ. Long-term repeatability of the skin prick test is high when supported by history or allergen-sensitivity tests: a prospective clinical study. Allergy. 2003 Nov;58(11):1180-6. doi: 10.1046/j.1398-9995.2003.00323.x.
- Results publication: PubMed 30052655Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.
- Results publication: PubMed 36389624Cheng Z, Yu S, Zhang W, Liu X, Shen Y, Weng H. Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2022 Sep 28;9(12):100152. doi: 10.1016/j.apjon.2022.100152. eCollection 2022 Dec.
- Individual participant dataSharing planned: 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.
Fulya Tahan, Prof. Dr. study chair
responsible for medical procedures
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by TC Erciyes 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kazim Bagci (+905336573633, kazimbagci@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Fear Scale (CFS) (time frame: 4 weeks). 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 NCT06401408, which also lists 9 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 6 May 2024.