Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children
NCT ID: NCT02246062
Last Updated: 2016-01-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
84 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-06-30
Study Completion Date
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial.
Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety.
Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.
Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety.
Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children
NCT04229199
Anxiety
COMPLETED
NA
Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
NCT02350504
Proportion of Anesthesia
Anxiety Level
COMPLETED
NA
Effect of Virtual Tour of the Operating Theater on Fear and Anxiety of Preoperative Children
NCT05401539
Preoperative Anxiety
UNKNOWN
NA
REducing Anxiety in CHildren Undergoing Procedures
NCT03054077
Ambulatory Surgery
COMPLETED
NA
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children
NCT02950415
Anxiety
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Introduction
Intense preoperative anxiety in children has been associated with difficulty in anesthetic induction. In addition, anxiety of relatives is a factor of great importance and influence on the preoperative anxiety levels of children and effectively contributes to the development of behavioral changes in postoperative period.
Distress before surgery has been associated with short- and long-term consequences, including risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease children's anxiety can provide suitable induction and minimizes these risks.
It is estimated that 40% to 75% of children undergoing surgery experience significant fear and anxiety during the preoperative period3-5 Several authors suggest that children under 4 years of age are at greater risk for developing anxiety preoperatively.
Among the strategies for reducing the pediatric population anxiety, the non-pharmacological approaches through alternative therapies that act on the psychological aspects are as important as the pharmacological ones 9.
Currently, there is great motivation towards non-pharmacological interventions aimed at anxiety relief for children and their families, such as parental presence during induction of anesthesia (PPIA), educational programs to prepare the family, and written information on anesthetic procedure provided to relatives and/or children. This is due in part to the large growth in outpatient practice and increased participation and presence of parents during children's hospitalization, but also to the new institutional strategies that motivate a more humane medical practice. Furthermore, there have emerged efficient behavioral intervention programs that use toys, cartoons, video games and smartphones.
It has been suggested the intuitive and easeness of use, and popularity, of smartphones as a way to make children become absorbed by scrolling through its menus, playing and investigating its other functions, hence making the anesthesiologists' approach trouble-free.
Some authors showed that using smartphone application and other electronic devices as part of a behavioral intervention program for children, while taking into account individual characteristics, may be a simple and effective way to reduce preoperative anxiety.
Objectives The aim of this study is to determine whether the quality of information provided to relatives at the ward and playing with age appropriate smartphone application may have an impact on prevalence and level of child's anxiety in the operating room (OR) at the induction of anesthesia.
Method
After approval by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo, an open randomized clinical trial should be conducted to compare the level of anxiety of children and their relatives, according to the quality of information and use or not of smartphone application received in the preanesthetic period.
Eighty-four children undergoing elective surgical procedures and their relatives will be randomly selected through the List Randomizer program (www.random.org) and allocated into four groups: control group (CG), in which the relative receive only conventional verbal information one day before the procedure at ward; informative group (IG), in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward; smartphone group (SG), in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room; smartphone and informative group (SIG) in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
Developed by the author, the leaflet consists of 17 brief items, such as questions and answers, and provides information regarding the most frequently asked questions by the relatives, as observed in our clinical practice. The contents of this informative leaflet cover aspects of the specialty and practice of anesthesiology, such as suspension and use of medications, fasting, full stomach and refeeding after anesthesia, laboratory tests, anesthesia in children, types of anesthesia, risks, induction and recovery room, presence of parents, and how to contribute to a peaceful anesthesia in children.
Inclusion criteria are ASA physical status I, II and III, according to the classification of the American Society of Anesthesiologists (ASA), age between 4 and 8 years, undergoing minor-medium elective surgical procedures with an indication of general anesthesia, who shall not receive premedication and whose parents are not illiterate.
The exclusion criteria for children are psychomotor deficits, use of psychoactive drugs, hearing and visual impairment, previous surgery; and for relatives, the exclusion criteria are illness or mental disorder clinically recognized and decline to participate.
The study begins always in the ward (W), one day before the procedure, during preanesthesia evaluation and on the conventional provision of information about anesthesia. One of the researchers applies the observational m-YPAS scale for child and then the relatives are fully informed about the characteristic of the study and will be asked to sign the consent form. At the end of the preanesthetic evaluation (APA) the relatives of the IG and SIG groups receive an information leaflet.
At the day of the procedure, in the waiting room (WR) of surgical centers, before the child is taken to the operating room (OR), the child anxiety is assessed by m-YPAS scale. All groups will also answer a sociodemographic questionnaire and open statement for satisfaction about the information received. The children of the groups SG and SIG, before taken to the OR receive smartphones for playing, remaining always accompanied by the relatives until the end of induction. In the OR, all children undergo standard monitoring and, immediately before induction of anesthesia through conventional technique (either intravenous or inhalational), are re-evaluated using m-YPAS (OR time).
Level and prevalence of children's anxiety (m-YPAS), will be measured at three times: ward (W), waiting room (WR) and operating room (OR) immediately before induction. The observational m-YPAS was used as originally proposed by Kain et al. A partial score was given for each domain, based on the score observed by the researcher, divided by the number of categories in that domain. The score for each domain is added to the others and then multiplied by 20. Cut-off scores to classify patients are: without anxiety (23.4-30), with anxiety (\< 30).
For sample size calculation, it was considered that the prevalence of children's anxiety in the operating room is 75% 23 and that the proposed intervention is able to reduce it by 35% 15. Thus, the investigators propose to use α-error of 5%, β-error of 20%, and confidence interval of 95%, totaling 84 patients, 21 in each group.
Intense preoperative anxiety in children has been associated with difficulty in anesthetic induction. In addition, anxiety of relatives is a factor of great importance and influence on the preoperative anxiety levels of children and effectively contributes to the development of behavioral changes in postoperative period.
Distress before surgery has been associated with short- and long-term consequences, including risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease children's anxiety can provide suitable induction and minimizes these risks.
It is estimated that 40% to 75% of children undergoing surgery experience significant fear and anxiety during the preoperative period3-5 Several authors suggest that children under 4 years of age are at greater risk for developing anxiety preoperatively.
Among the strategies for reducing the pediatric population anxiety, the non-pharmacological approaches through alternative therapies that act on the psychological aspects are as important as the pharmacological ones 9.
Currently, there is great motivation towards non-pharmacological interventions aimed at anxiety relief for children and their families, such as parental presence during induction of anesthesia (PPIA), educational programs to prepare the family, and written information on anesthetic procedure provided to relatives and/or children. This is due in part to the large growth in outpatient practice and increased participation and presence of parents during children's hospitalization, but also to the new institutional strategies that motivate a more humane medical practice. Furthermore, there have emerged efficient behavioral intervention programs that use toys, cartoons, video games and smartphones.
It has been suggested the intuitive and easeness of use, and popularity, of smartphones as a way to make children become absorbed by scrolling through its menus, playing and investigating its other functions, hence making the anesthesiologists' approach trouble-free.
Some authors showed that using smartphone application and other electronic devices as part of a behavioral intervention program for children, while taking into account individual characteristics, may be a simple and effective way to reduce preoperative anxiety.
Objectives The aim of this study is to determine whether the quality of information provided to relatives at the ward and playing with age appropriate smartphone application may have an impact on prevalence and level of child's anxiety in the operating room (OR) at the induction of anesthesia.
Method
After approval by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo, an open randomized clinical trial should be conducted to compare the level of anxiety of children and their relatives, according to the quality of information and use or not of smartphone application received in the preanesthetic period.
Eighty-four children undergoing elective surgical procedures and their relatives will be randomly selected through the List Randomizer program (www.random.org) and allocated into four groups: control group (CG), in which the relative receive only conventional verbal information one day before the procedure at ward; informative group (IG), in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward; smartphone group (SG), in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room; smartphone and informative group (SIG) in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
Developed by the author, the leaflet consists of 17 brief items, such as questions and answers, and provides information regarding the most frequently asked questions by the relatives, as observed in our clinical practice. The contents of this informative leaflet cover aspects of the specialty and practice of anesthesiology, such as suspension and use of medications, fasting, full stomach and refeeding after anesthesia, laboratory tests, anesthesia in children, types of anesthesia, risks, induction and recovery room, presence of parents, and how to contribute to a peaceful anesthesia in children.
Inclusion criteria are ASA physical status I, II and III, according to the classification of the American Society of Anesthesiologists (ASA), age between 4 and 8 years, undergoing minor-medium elective surgical procedures with an indication of general anesthesia, who shall not receive premedication and whose parents are not illiterate.
The exclusion criteria for children are psychomotor deficits, use of psychoactive drugs, hearing and visual impairment, previous surgery; and for relatives, the exclusion criteria are illness or mental disorder clinically recognized and decline to participate.
The study begins always in the ward (W), one day before the procedure, during preanesthesia evaluation and on the conventional provision of information about anesthesia. One of the researchers applies the observational m-YPAS scale for child and then the relatives are fully informed about the characteristic of the study and will be asked to sign the consent form. At the end of the preanesthetic evaluation (APA) the relatives of the IG and SIG groups receive an information leaflet.
At the day of the procedure, in the waiting room (WR) of surgical centers, before the child is taken to the operating room (OR), the child anxiety is assessed by m-YPAS scale. All groups will also answer a sociodemographic questionnaire and open statement for satisfaction about the information received. The children of the groups SG and SIG, before taken to the OR receive smartphones for playing, remaining always accompanied by the relatives until the end of induction. In the OR, all children undergo standard monitoring and, immediately before induction of anesthesia through conventional technique (either intravenous or inhalational), are re-evaluated using m-YPAS (OR time).
Level and prevalence of children's anxiety (m-YPAS), will be measured at three times: ward (W), waiting room (WR) and operating room (OR) immediately before induction. The observational m-YPAS was used as originally proposed by Kain et al. A partial score was given for each domain, based on the score observed by the researcher, divided by the number of categories in that domain. The score for each domain is added to the others and then multiplied by 20. Cut-off scores to classify patients are: without anxiety (23.4-30), with anxiety (\< 30).
For sample size calculation, it was considered that the prevalence of children's anxiety in the operating room is 75% 23 and that the proposed intervention is able to reduce it by 35% 15. Thus, the investigators propose to use α-error of 5%, β-error of 20%, and confidence interval of 95%, totaling 84 patients, 21 in each group.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Anxiety State
Parent-Child Relations
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
in which the relative receive only conventional verbal information one day before the procedure at ward.
Group Type
NO_INTERVENTION
No interventions assigned to this group
info group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
Group Type
ACTIVE_COMPARATOR
info
Intervention Type
BEHAVIORAL
the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone group
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
Group Type
ACTIVE_COMPARATOR
smartphone
Intervention Type
BEHAVIORAL
the child received smartphone application immediately before entering the operating room
smartphone and info group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
Group Type
ACTIVE_COMPARATOR
info
Intervention Type
BEHAVIORAL
the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone
Intervention Type
BEHAVIORAL
the child received smartphone application immediately before entering the operating room
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
info
the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
Intervention Type
BEHAVIORAL
smartphone
the child received smartphone application immediately before entering the operating room
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ASA physical status I, II and III a
* age between 4 and 8 years
* undergoing minor-medium elective surgical procedures
* indication of general anesthesia
* not receive premedication
* parents are not illiterate.
* age between 4 and 8 years
* undergoing minor-medium elective surgical procedures
* indication of general anesthesia
* not receive premedication
* parents are not illiterate.
Exclusion Criteria
* psychomotor deficits
* use of psychoactive drugs
* hearing and visual impairment
* previous surgery
* for relatives, illness or mental disorder clinically recognized and decline to participate.
* use of psychoactive drugs
* hearing and visual impairment
* previous surgery
* for relatives, illness or mental disorder clinically recognized and decline to participate.
Minimum Eligible Age
4 Years
Maximum Eligible Age
8 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Faculdade de Ciências Médicas da Santa Casa de São Paulo
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Débora de Oliveira Cumino
MSC
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ligia AS Mathias, PhD
Role: STUDY_DIRECTOR
Irmandade Santa Casa de Misericórdia de São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Brazil
References
Explore related publications, articles, or registry entries linked to this study.
Melamed BG, Siegel LJ. Reduction of anxiety in children facing hospitalization and surgery by use of filmed modeling. J Consult Clin Psychol. 1975 Aug;43(4):511-21. doi: 10.1037/h0076896. No abstract available.
Reference Type
BACKGROUND
Lumley MA, Melamed BG, Abeles LA. Predicting children's presurgical anxiety and subsequent behavior changes. J Pediatr Psychol. 1993 Aug;18(4):481-97. doi: 10.1093/jpepsy/18.4.481.
Reference Type
BACKGROUND
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
Reference Type
BACKGROUND
ECKENHOFF JE. Relationship of anesthesia to postoperative personality changes in children. AMA Am J Dis Child. 1953 Nov;86(5):587-91. doi: 10.1001/archpedi.1953.02050080600004. No abstract available.
Reference Type
BACKGROUND
Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.
Reference Type
BACKGROUND
Bevan JC, Johnston C, Haig MJ, Tousignant G, Lucy S, Kirnon V, Assimes IK, Carranza R. Preoperative parental anxiety predicts behavioural and emotional responses to induction of anaesthesia in children. Can J Anaesth. 1990 Mar;37(2):177-82. doi: 10.1007/BF03005466.
Reference Type
BACKGROUND
Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
Reference Type
BACKGROUND
Kain ZN, Mayes LC, Weisman SJ, Hofstadter MB. Social adaptability, cognitive abilities, and other predictors for children's reactions to surgery. J Clin Anesth. 2000 Nov;12(7):549-54. doi: 10.1016/s0952-8180(00)00214-2.
Reference Type
BACKGROUND
Kain ZN, Mayes LC, Caldwell-Andrews AA, Saadat H, McClain B, Wang SM. Predicting which children benefit most from parental presence during induction of anesthesia. Paediatr Anaesth. 2006 Jun;16(6):627-34. doi: 10.1111/j.1460-9592.2006.01843.x.
Reference Type
BACKGROUND
Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
Reference Type
BACKGROUND
Astuto M, Rosano G, Rizzo G, Disma N, Raciti L, Sciuto O. Preoperative parental information and parents' presence at induction of anaesthesia. Minerva Anestesiol. 2006 Jun;72(6):461-5.
Reference Type
BACKGROUND
Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.
Reference Type
BACKGROUND
Chundamala J, Wright JG, Kemp SM. An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. Can J Anaesth. 2009 Jan;56(1):57-70. doi: 10.1007/s12630-008-9008-3. Epub 2008 Dec 20.
Reference Type
BACKGROUND
Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.
Reference Type
BACKGROUND
Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
Reference Type
BACKGROUND
Lee JH, Jung HK, Lee GG, Kim HY, Park SG, Woo SC. Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients. Korean J Anesthesiol. 2013 Dec;65(6):508-18. doi: 10.4097/kjae.2013.65.6.508. Epub 2013 Dec 26.
Reference Type
BACKGROUND
Low DK, Pittaway AP. The 'iPhone' induction - a novel use for the Apple iPhone. Paediatr Anaesth. 2008 Jun;18(6):573-4. doi: 10.1111/j.1460-9592.2008.02498.x. Epub 2008 Feb 28. No abstract available.
Reference Type
BACKGROUND
Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
Reference Type
BACKGROUND
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Reference Type
BACKGROUND
Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. doi: 10.1590/s0034-70942007000100006. English, Portuguese.
Reference Type
BACKGROUND
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Reference Type
BACKGROUND
Cumino Dde O, Cagno G, Goncalves VF, Wajman DS, Mathias LA. Impact of preanesthetic information on anxiety of parents and children. Braz J Anesthesiol. 2013 Nov-Dec;63(6):473-82. doi: 10.1016/j.bjane.2013.04.003. Epub 2013 Dec 5.
Reference Type
BACKGROUND
Cumino DO, Vieira JE, Lima LC, Stievano LP, Silva RA, Mathias LA. Smartphone-based behavioural intervention alleviates children's anxiety during anaesthesia induction: A randomised controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):169-175. doi: 10.1097/EJA.0000000000000589.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
288.712
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
StoryTelling Medicine Application Using a Virtual Reality Intervention
NCT02687243
RECRUITING
NA
Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety
NCT06826352
COMPLETED
NA
Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children
NCT06237894
NOT_YET_RECRUITING
NA
The Effects of Familiar Toy and Parental Presence Combination on Perioperative Pediatric Anxiety
NCT06459089
COMPLETED
Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial
NCT03531359
UNKNOWN
NA
Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children
NCT03902158
UNKNOWN
NA
The Effects of Vibration and Pressure Interventions
NCT05656066
COMPLETED
NA
The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre
NCT06303843
COMPLETED
NA
Interactive Robot on Pre-operative Anxiety and Fear of Children
NCT06148844
COMPLETED
NA
Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
NCT01688115
COMPLETED
NA
Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety?
NCT06292663
COMPLETED
NA
Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety
NCT04348903
UNKNOWN
NA
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
NCT07270029
NOT_YET_RECRUITING
NA
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children
NCT05828264
COMPLETED
NA
Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety
NCT05434832
UNKNOWN
NA
VR for Preoperative Anxiety in Children
NCT03201640
COMPLETED
NA
Effectiveness of Mobile Application Intervention in Day Surgery
NCT03774303
COMPLETED
NA
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
NCT06604364
RECRUITING
NA
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
NCT00569647
COMPLETED
NA
The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia
NCT03922009
COMPLETED
NA
Comparison of Virtual Reality to Tablet-based Distraction in Children
NCT04414501
COMPLETED
NA
Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
NCT03220828
COMPLETED
NA
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure
NCT06071390
COMPLETED
NA
Effects of Virtual Reality on Perioperative Pediatric Anxiety
NCT04043663
UNKNOWN
NA
Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children
NCT07128056
NOT_YET_RECRUITING
NA