Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?

NCT00932685 | Completed

• 1 other identifier: 0120030315A
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.

Conditions

Pediatric Emergence Agitation and Pain

Keywords

pediatric emergence agitation and pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

Secondary Outcomes (1)

• emergence agitation

  on arrival, at 5 minutes and every 10 min for one hour in PACU

Study Arms (2)

2. Video Game

ACTIVE COMPARATOR

Device: Game Boy

1. Midazolam 0.5mg/kg

ACTIVE COMPARATOR

Drug: Midazolam

Interventions

Midazolam DRUG

Midazolam 0.5mg/kg

1. Midazolam 0.5mg/kg

Game Boy DEVICE

Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction

Also known as: Nintendo-DS Game Boy

2. Video Game

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA rating of I-II Mask induction of General Anesthesia

You may not qualify if:

• Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Nintendo of North America: collaborator

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anuradha Patel, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Study Start: December 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 3, 2009

Record last verified: 2009-07

Locations

US (1)