Anxiety, Separation Clinical Trial
Official title:
A Comparison of Virtual Reality Headset and Touch Screen Tablet for Minimizing Anxiety During Separation From Caregiver and Induction of Anesthesia in Children
NCT number | NCT04414501 |
Other study ID # | 5180036 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 30, 2018 |
Est. completion date | April 2, 2020 |
Verified date | March 2021 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.
Status | Completed |
Enrollment | 94 |
Est. completion date | April 2, 2020 |
Est. primary completion date | April 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | Inclusion Criteria: - Children 4-10 years of age - Undergoing procedure that requires general anesthesia Exclusion Criteria: - Emergent procedure - ASA III-IV - Patients with facial skin lesions - Patients with significant history of motion sickness - Visually impaired patients - Patients unable to wear a virtual reality headset - Patients receiving pharmacological intervention to decrease preoperative anxiety |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Cox RG, Nemish U, Ewen A, Crowe MJ. Evidence-based clinical update: does premedication with oral midazolam lead to improved behavioural outcomes in children? Can J Anaesth. 2006 Dec;53(12):1213-9. Review. — View Citation
Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100. — View Citation
Esteve R, Marquina-Aponte V, Ramírez-Maestre C. Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers' responses to children's pain. J Pain. 2014 Feb;15(2):157-68.e1. doi: 10.1016/j.jpain.2013.10.007. Epub 2013 Oct 27. — View Citation
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. — View Citation
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. — View Citation
Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586. — View Citation
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. — View Citation
Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4. — View Citation
Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17. — View Citation
Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15. — View Citation
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation
Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. — View Citation
Weiss KE, Dahlquist LM, Wohlheiter K. The effects of interactive and passive distraction on cold pressor pain in preschool-aged children. J Pediatr Psychol. 2011 Aug;36(7):816-26. doi: 10.1093/jpepsy/jsq125. Epub 2011 Jan 29. — View Citation
Wohlheiter KA, Dahlquist LM. Interactive versus passive distraction for acute pain management in young children: the role of selective attention and development. J Pediatr Psychol. 2013 Mar;38(2):202-12. doi: 10.1093/jpepsy/jss108. Epub 2012 Oct 23. — View Citation
Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7). pii: E52. doi: 10.3390/children4070052. Review. — View Citation
Yang KS, Habib AS, Lu M, Branch MS, Muir H, Manberg P, Sigl JC, Gan TJ. A prospective evaluation of the incidence of adverse events in nurse-administered moderate sedation guided by sedation scores or Bispectral Index. Anesth Analg. 2014 Jul;119(1):43-8. doi: 10.1213/ANE.0b013e3182a125c3. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient anxiety at the time of separation in children before surgical procedures | We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety). | Preoperative Period | |
Secondary | additional anxiety scoring techniques | Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much). | Preoperative period | |
Secondary | Mask acceptance by the patient | Mask Acceptance Scores | Intraoperative period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02310152 -
Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
|
N/A | |
Completed |
NCT00012584 -
Treatment of Youth With ADHD and Anxiety
|
N/A | |
Recruiting |
NCT02459509 -
A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children
|
Phase 4 | |
Completed |
NCT04950088 -
Reduction of Perioperative Anxiety Using a Hand-held Video Game Device
|
N/A | |
Completed |
NCT01470469 -
SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
|
Phase 2 | |
Recruiting |
NCT04598230 -
Partners in Caring for Anxious Youth
|
Phase 3 | |
Completed |
NCT02027844 -
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
|
N/A |