BronchiolitisNCT05839054
Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children
A study testing Virtual Reality audio and visual glass (Roller Coasters, group 1) and Virtual Reality audio and visual glass (Wild Dolphins, group 2) in people with Bronchiolitis and Anxiety, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Virtual reality (VR) glasses are technological devices that are often used in medical fields recently and are seen as suitable for distracting children. In the last few years, many studies have been conducted to facilitate pediatric patients against painful or frightening medical procedures. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Bronchiolitis, Anxiety
- What is being tested?
- Virtual Reality audio and visual glass (Roller Coasters, group 1) and Virtual Reality audio and visual glass (Wild Dolphins, group 2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 1 Apr 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 2-5 years old
- Children who need inhaler treatment (salbutamol)
- Children whose families give consent to participants the study
Who cannot join
- Children with neuromotor retardation,
- Visual and auditory problems,
- Underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy),
- Obesity or malnutrition (to equalize the effectiveness of the drug dose),
- Adrenaline, budesonide or those who receive ipratropium bromide treatment,
- Those who will receive inhaler inhaler treatment for the first time,
Show all 15Show fewer
- Those who have received inhaler treatment in the last 72 hours,
- Those who have a previous operation or sedative history,
- Those who have a fever above 37.5°C,
- Those who have used VR before,
- Patients with a saturation value below 92% at the time of admission,
- Those presenting with severe asthma attack,
- Those with respiratory failure symptoms,
- Patients with a score of 5 and above according to the bronchiolitis severity score
- Those under 2 years of age to avoid screen exposure patients (infants) and patients over 5 years old (school period)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
UHS Haseki Training and Research Hospital
Istanbul, Sultangazi, 34304
About this study
Virtual reality (VR) glasses are technological devices that are often used in medical fields recently and are seen as suitable for distracting children. In the last few years, many studies have been conducted to facilitate pediatric patients against painful or frightening medical procedures. For uncomfortable procedures, distracting the child's attention is seen as the most important point. VR technology has been used for procedures such as burn cases, tooth extraction, intramuscular injection, intravenous cannula, lumbar puncture, and the results of the research have been found to be satisfactory. Using VR glasses alone or in combination with standard care is effective in reducing pain and anxiety. So far, there is no study in the literature on distraction with VR during inhaler treatment in pediatric patients. Children cannot receive inhaler treatment efficiently due to reasons such as restlessness, crying, and pulling the mask during inhaler treatment, and their hospital stay is prolonged. In this study, the investigators planned to compare the patients who received inhaler treatment with VR glasses with the patients who received treatment without the aid of any device in terms of treatment compliance.
Thus, the investigators aimed to make the inhaler treatment more comfortable with VR technology.
Read the detailed description
The study was designed by including children aged 2-5 years, who needed inhaler treatment (salbutamol) between 10.11.2022 and 01.04.2023, whose families gave consent for the study. This age group (preschool) was chosen because it is the age group that presents the most difficulties to families and physicians during inhaler treatment and screen exposure does not cause problems up to a certain point. The study was conducted as a prospective, single-blind, randomized, controlled study in the Pediatric Emergency Department of the Health Sciences University Haseki Training and Research Hospital.
Children with neuromotor retardation, visual and auditory problems, underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy), obesity or malnutrition (to equalize the effectiveness of the drug dose), adrenaline, budesonide or Those who receive ipratropium bromide treatment, those who will receive inhaler nebula treatment for the first time, those who have received inhaler treatment in the last 72 hours, those who have a previous operation or sedative history, those who have a fever above 37.5°C, those who have used VR before, those under 2 years of age to avoid screen exposure children (infants) and children over 5 years old (school period) were excluded from the study. In addition, children with a saturation value below 92% at the time of admission, those presenting with severe asthma attacks and those with respiratory failure symptoms were not included in the study. Children with a score of 5 and above according to the bronchiolitis severity score were excluded from the study.
The children included in the study were divided into 3 groups by randomization method: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2) and those who did not use any additional equipment. (group 3). These children were observed during their 15-minute inhaler treatment and the groups were compared in terms of crying times, changes in RR, SpO2, HR values with pre- and post-treatment physician questionnaires and family questionnaires.
In the comparison study of Gerceker et al., with VR glasses in children from whom blood was drawn, the pain score was found to be 1.2 ± 2.2 in children using VR glasses, and 4.1 ± 3.5 in children without VR (control group), and the standard effect size was determined as 0.99 in the power analysis based on these data. When the number of 45 cases in each group is taken, the power of the study was calculated to be with a 1% margin of error and 98% power.
During the study period (November 2022 - April 2023), 913 children received inhaler treatment in our hospital. Children who met the selection criteria and whose families agreed to participate in the study were included in the study, and the study was terminated when the target number of 135 children was reached. 689 children who did not meet the inclusion criteria (such as chronic disease or severe bronchiolitis) and were not suitable for their age (such as under 2 years old, over 5 years old) were excluded from the study. Of the 224 children who met the inclusion criteria, 89 were excluded because they refused to participate in the study.
The children to be included in the study were determined by randomization method. For randomization, the site named randomizer.org was used to randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.
The children included in the study were divided into 3 groups: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2), and those who did not use any additional equipment (group 3). 3D Roller Coasters and 3D Wild Dolphins videos were used as VR images via Youtube application (Google LLC. California, USA; Youtube®). VR glasses were integrated into the tablet and given to the accompanying parent, so that the parent could see what their child was watching at that moment.
Children in all groups were given 'salbutamol' inhaler treatment for 15 minutes, and equality was achieved between the groups in terms of treatment active substance and duration. Salbutamol was given to each child as 2.5 mg/2.5 ml. The children were observed during their 15-minute inhaler treatment, and the crying times were compared with the anxiety scoring made by the same doctor before and after the treatment, and the minute respiratory rate (RR), oxygen saturation (SpO2), heart rate change (HR) and the duration of inhaler treatment were compared. In addition, families filled out questionnaires about their children's mental state before and after the treatment. The FLACC (Face, Legs, Activity, Cry, consolability) Pain Assessment Scale was used for the anxiety scoring made by the physician, and the Yale Modified Anxiety Scale (MYPAS), which was thought to be appropriate for our study, although it was designed to measure pre-operative anxiety. For families, a form consisting of eight 'yes-no' questions called the Parents' Pain Measure (MPPM), modified by us and normally used for post-operative anxiety/pain measurement, was used. In addition, Wong Baker Faces Pain Rating Scale (WBS) was also used to evaluate the anxiety of the children for convenience to the family.
The children to be included in the study were determined by a single researcher. The first investigator identified the children who met the inclusion criteria, noted the FLACC and MYPAS score, as well as the RR, SpO2, and HR values, and referred the child to the other investigator. The second investigator divided the child into his group using the randomization method, and determined the duration of crying and effective treatment, along with the duration of treatment, with a double chronometer during treatment. At the end of the treatment, the family and the child were re-directed to the first researcher on the condition that they did not tell the first researcher which group they were in. Thus, it was ensured that the first investigator did not know which group the child belonged to while filling in the FLACC and MYPAS score before and after the treatment and determining SpO2, RR and HR. In addition, with the MPPM and WBS performed by the families, the changes in the children's discomfort/restlessness were determined from the family's point of view before and after the treatment.
Newly opened sterile masks were used for inhalation therapy in each child. In order to standardize the treatment, the 'Omron® CompAIR Pro NE-C900 Compressor Nebulizer' was used as a nebulizer. After each child, the infected materials of the VR glasses were removed with a surface disinfectant containing didecyldimethylammonium chloride and left in a disinfectant containing non-abrasive quarter ammonium carbonate, non-ionic surface active material and enzymatic complex, then rinsed with distilled water and waited until dry.
- Conditions
- Bronchiolitis, Anxiety
- Being tested
- Virtual Reality audio and visual glass (Roller Coasters, group 1), Virtual Reality audio and visual glass (Wild Dolphins, group 2)
- Keywords
- Inhaler treatment, Children, Virtual reality glasses
- Medical subject headings
- Bronchiolitis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality audio and visual glass (Roller Coasters, group 1)Device
During the inhaler treatment, the child was shown Roller Coasters with VR glasses.
Virtual Reality audio and visual glass (Wild Dolphins, group 2)Device
During the inhaler treatment, the child was shown Wild Dolphins with VR glasses.
| Study group | Role | What they receive |
|---|---|---|
| Roller Coasters, group 1 | Experimental | VR audio-visual users with Roller Coasters Receives: Device: Virtual Reality audio and visual glass (Roller Coasters, group 1) |
| Wild Dolphins, group 2 | Experimental | VR audio-visual users with Wild Dolphins Receives: Device: Virtual Reality audio and visual glass (Wild Dolphins, group 2) |
| group 3 | No intervention | did not use any additional equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system
Changing pain scores by helping with uncomfortable procedures for children. The researchers used the FLACC (Face, Legs, Activity, Cry and Consolability ) scoring and scored between 0 and 10. A higher score indicated more pain and restlessness.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start10 Nov 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The children randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berker Okay, Haseki Training and Research Hospital
- Investigators
- Berker Okay, M.D., Principal investigator, Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839054
- Sponsor's protocol ID
- 22/197
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD are available from the principal investigator upon reasonable request
Publications
Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
PubMed 15745448Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
PubMed 18325675Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
PubMed 31889358Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
PubMed 16640481Althumairi A, Sahwan M, Alsaleh S, Alabduljobar Z, Aljabri D. Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination? J Multidiscip Healthc. 2021 Sep 21;14:2625-2632. doi: 10.2147/JMDH.S327349. eCollection 2021.
PubMed 34584419
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children
- ClinicalTrials.gov ID
- NCT05839054
- Acronym / sponsor ID
- 22/197
- Conditions
- Bronchiolitis, Anxiety
- Keywords
- Inhaler treatment, Children, Virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 3 May 2023 (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.
Virtual reality (VR) glasses are technological devices that are often used in medical fields recently and are seen as suitable for distracting children. In the last few years, many studies have been conducted to facilitate pediatric patients against painful or frightening medical procedures. For uncomfortable procedures, distracting the child's attention is seen as the most important point. VR technology has been used for procedures such as burn cases, tooth extraction, intramuscular injection, intravenous cannula, lumbar puncture, and the results of the research have been found to be satisfactory. Using VR glasses alone or in combination with standard care is effective in reducing pain and anxiety. So far, there is no study in the literature on distraction with VR during inhaler treatment in pediatric patients. Children cannot receive inhaler treatment efficiently due to reasons such as restlessness, crying, and pulling the mask during inhaler treatment, and their hospital stay is prolonged. In this study, the investigators planned to compare the patients who received inhaler treatment with VR glasses with the patients who received treatment without the aid of any device in terms of treatment compliance.
Thus, the investigators aimed to make the inhaler treatment more comfortable with VR technology.
Detailed description
The study was designed by including children aged 2-5 years, who needed inhaler treatment (salbutamol) between 10.11.2022 and 01.04.2023, whose families gave consent for the study. This age group (preschool) was chosen because it is the age group that presents the most difficulties to families and physicians during inhaler treatment and screen exposure does not cause problems up to a certain point. The study was conducted as a prospective, single-blind, randomized, controlled study in the Pediatric Emergency Department of the Health Sciences University Haseki Training and Research Hospital.
Children with neuromotor retardation, visual and auditory problems, underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy), obesity or malnutrition (to equalize the effectiveness of the drug dose), adrenaline, budesonide or Those who receive ipratropium bromide treatment, those who will receive inhaler nebula treatment for the first time, those who have received inhaler treatment in the last 72 hours, those who have a previous operation or sedative history, those who have a fever above 37.5°C, those who have used VR before, those under 2 years of age to avoid screen exposure children (infants) and children over 5 years old (school period) were excluded from the study. In addition, children with a saturation value below 92% at the time of admission, those presenting with severe asthma attacks and those with respiratory failure symptoms were not included in the study. Children with a score of 5 and above according to the bronchiolitis severity score were excluded from the study.
The children included in the study were divided into 3 groups by randomization method: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2) and those who did not use any additional equipment. (group 3). These children were observed during their 15-minute inhaler treatment and the groups were compared in terms of crying times, changes in RR, SpO2, HR values with pre- and post-treatment physician questionnaires and family questionnaires.
In the comparison study of Gerceker et al., with VR glasses in children from whom blood was drawn, the pain score was found to be 1.2 ± 2.2 in children using VR glasses, and 4.1 ± 3.5 in children without VR (control group), and the standard effect size was determined as 0.99 in the power analysis based on these data. When the number of 45 cases in each group is taken, the power of the study was calculated to be with a 1% margin of error and 98% power.
During the study period (November 2022 - April 2023), 913 children received inhaler treatment in our hospital. Children who met the selection criteria and whose families agreed to participate in the study were included in the study, and the study was terminated when the target number of 135 children was reached. 689 children who did not meet the inclusion criteria (such as chronic disease or severe bronchiolitis) and were not suitable for their age (such as under 2 years old, over 5 years old) were excluded from the study. Of the 224 children who met the inclusion criteria, 89 were excluded because they refused to participate in the study.
The children to be included in the study were determined by randomization method. For randomization, the site named randomizer.org was used to randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.
The children included in the study were divided into 3 groups: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2), and those who did not use any additional equipment (group 3). 3D Roller Coasters and 3D Wild Dolphins videos were used as VR images via Youtube application (Google LLC. California, USA; Youtube®). VR glasses were integrated into the tablet and given to the accompanying parent, so that the parent could see what their child was watching at that moment.
Children in all groups were given 'salbutamol' inhaler treatment for 15 minutes, and equality was achieved between the groups in terms of treatment active substance and duration. Salbutamol was given to each child as 2.5 mg/2.5 ml. The children were observed during their 15-minute inhaler treatment, and the crying times were compared with the anxiety scoring made by the same doctor before and after the treatment, and the minute respiratory rate (RR), oxygen saturation (SpO2), heart rate change (HR) and the duration of inhaler treatment were compared. In addition, families filled out questionnaires about their children's mental state before and after the treatment. The FLACC (Face, Legs, Activity, Cry, consolability) Pain Assessment Scale was used for the anxiety scoring made by the physician, and the Yale Modified Anxiety Scale (MYPAS), which was thought to be appropriate for our study, although it was designed to measure pre-operative anxiety. For families, a form consisting of eight 'yes-no' questions called the Parents' Pain Measure (MPPM), modified by us and normally used for post-operative anxiety/pain measurement, was used. In addition, Wong Baker Faces Pain Rating Scale (WBS) was also used to evaluate the anxiety of the children for convenience to the family.
The children to be included in the study were determined by a single researcher. The first investigator identified the children who met the inclusion criteria, noted the FLACC and MYPAS score, as well as the RR, SpO2, and HR values, and referred the child to the other investigator. The second investigator divided the child into his group using the randomization method, and determined the duration of crying and effective treatment, along with the duration of treatment, with a double chronometer during treatment. At the end of the treatment, the family and the child were re-directed to the first researcher on the condition that they did not tell the first researcher which group they were in. Thus, it was ensured that the first investigator did not know which group the child belonged to while filling in the FLACC and MYPAS score before and after the treatment and determining SpO2, RR and HR. In addition, with the MPPM and WBS performed by the families, the changes in the children's discomfort/restlessness were determined from the family's point of view before and after the treatment.
Newly opened sterile masks were used for inhalation therapy in each child. In order to standardize the treatment, the 'Omron® CompAIR Pro NE-C900 Compressor Nebulizer' was used as a nebulizer. After each child, the infected materials of the VR glasses were removed with a surface disinfectant containing didecyldimethylammonium chloride and left in a disinfectant containing non-abrasive quarter ammonium carbonate, non-ionic surface active material and enzymatic complex, then rinsed with distilled water and waited until dry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The children randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.
| Arm | Type | Receives |
|---|---|---|
| Roller Coasters, group 1 | Experimental | Device: Virtual Reality audio and visual glass (Roller Coasters, group 1)VR audio-visual users with Roller Coasters |
| Wild Dolphins, group 2 | Experimental | Device: Virtual Reality audio and visual glass (Wild Dolphins, group 2)VR audio-visual users with Wild Dolphins |
| group 3 | No intervention | –did not use any additional equipment |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 2-5 years old
- Children who need inhaler treatment (salbutamol)
- Children whose families give consent to participants the study
Key exclusion criteria (15 listed)
- Children with neuromotor retardation,
- Visual and auditory problems,
- Underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy),
- Obesity or malnutrition (to equalize the effectiveness of the drug dose),
- Adrenaline, budesonide or those who receive ipratropium bromide treatment,
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 |
|---|---|---|
| Virtual Reality audio and visual glass (Roller Coasters, group 1)During the inhaler treatment, the child was shown Roller Coasters with VR glasses. | Device | Roller Coasters, group 1 |
| Virtual Reality audio and visual glass (Wild Dolphins, group 2)During the inhaler treatment, the child was shown Wild Dolphins with VR glasses. | Device | Wild Dolphins, group 2 |
Primary outcome
Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system
Time frame: Baseline
Changing pain scores by helping with uncomfortable procedures for children. The researchers used the FLACC (Face, Legs, Activity, Cry and Consolability ) scoring and scored between 0 and 10. A higher score indicated more pain and restlessness.
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 Mar 2024.
- Results publication: PubMed 15745448Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
- Results publication: PubMed 18325675Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
- Results publication: PubMed 31889358Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
- Results publication: PubMed 16640481Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
- Results publication: PubMed 34584419Althumairi A, Sahwan M, Alsaleh S, Alabduljobar Z, Aljabri D. Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination? J Multidiscip Healthc. 2021 Sep 21;14:2625-2632. doi: 10.2147/JMDH.S327349. eCollection 2021.
- Individual participant dataSharing planned: No. The IPD are available from the principal investigator upon reasonable request
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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.
Berker Okay, M.D. principal investigator
Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality audio and visual glass (Roller Coasters, group 1) and Virtual Reality audio and visual glass (Wild Dolphins, group 2) in people with Bronchiolitis and Anxiety, run by Haseki Training and Research Hospital 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 3 inclusion and 15 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 Mar 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?
Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system (time frame: Baseline). 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 NCT05839054, which also lists 5 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 Mar 2024.