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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05839054
Study groupRoleWhat they receive
Roller Coasters, group 1ExperimentalVR audio-visual users with Roller Coasters
Receives: Device: Virtual Reality audio and visual glass (Roller Coasters, group 1)
Wild Dolphins, group 2ExperimentalVR audio-visual users with Wild Dolphins
Receives: Device: Virtual Reality audio and visual glass (Wild Dolphins, group 2)
group 3No interventiondid not use any additional equipment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted3 May 2023
  2. Study start10 Nov 2022
  3. Primary completion1 Mar 2023
  4. Study completion1 Apr 2023

Resources

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)
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 15745448
  • Mott 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 18325675
  • Ozalp 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 31889358
  • Gold 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 16640481
  • Althumairi 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

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.

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