Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839054
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2023-04-07
Brief Title:
Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 For uncomfortable procedures distracting the childs 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
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 10112022 and 01042023 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 375C 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 12 22 in children using VR glasses and 41 35 in children without VR control group and the standard effect size was determined as 099 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 randomizerorg 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 25 mg25 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 childrens 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 anxietypain 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 childrens discomfortrestlessness were determined from the familys 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
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 375C 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 12 22 in children using VR glasses and 41 35 in children without VR control group and the standard effect size was determined as 099 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 randomizerorg 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 25 mg25 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 childrens 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 anxietypain 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 childrens discomfortrestlessness were determined from the familys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None