Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

• ClinicalTrials.gov Identifier: NCT02027844
• Recruitment Status: Completed
• First Posted: January 6, 2014
• Results First Posted: November 1, 2015
• Last Update Posted: November 1, 2015
• Sponsor: Yeungnam University College of Medicine
• Information provided by (Responsible Party): Sung Mee Jung, Yeungnam University College of Medicine

Study Description

Brief Summary:

Nearly 50% of young children undergoing surgery exhibit high level of anxiety during induction of anesthesia because of exposure to unfamiliar environment and people and separation from parents. Increased preoperative anxiety may impact postoperative behavior changes such as emergence agitation, separation anxiety and sleep disturbance. Although some pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during induction of anesthesia, previous studies have reported conflicting results. Recently the distraction using video game or animated cartoon has been reported to reduce anxiety of young children during induction of anesthesia. However, it was still undetermined whether distraction has its own ability to reduce children's anxiety separated from parental presence because they evaluated the effect of video method in the parental presence. The investigators design to investigated the efficacy of distraction with watching cartoon, parental presence and combined with watching cartoon and parental presence on reduction of anxiety during inhalational induction of anesthesia using sevoflurane. In addition this study includes long-term effect of each intervention such as postoperative emergence agitation and postoperative behavior change in children.

Condition or disease	Intervention/treatment	Phase
Anxiety, Separation; Psychomotor Agitation	Behavioral: Cartoon; Behavioral: parental presence	Not Applicable

Detailed Description:

This study is different from previous reports as follow. First, investigators separate the effect of cartoon distraction and parental presence on minimizing preoperative anxiety and determine whether an interaction between two different interventions is existent. Second, investigators evaluate the effect of preoperative anxiety on the long-term behavioral change of children. It was not clarified yet in clinical practice. Third, investigators evaluate the effect of each intervention on parental anxiety before and after induction of anesthesia.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia
• Study Start Date: December 2013
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cartoon; cartoon watching by children during inhalational induction of anesthesia in the operating room	Behavioral: Cartoon; Cartoon watching by children during inhalational induction of sevoflurane; Other Name: Cartoon watching by children
Active Comparator: Paretnal presence; parental presence with their children during inhalational induction of anesthesia in the operating room	Behavioral: parental presence; parental presence during inhalational induction of sevoflurane
Experimental: Combined; parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room	Behavioral: Cartoon; Cartoon watching by children during inhalational induction of sevoflurane; Other Name: Cartoon watching by children; Behavioral: parental presence; parental presence during inhalational induction of sevoflurane

Outcome Measures

Primary Outcome Measures :

1. Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction [ Time Frame: 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane ]

   The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.

   Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others

   Total scores ranged from 23.4 to 100 The scores considered "cut points" to determine whether a patient had/had not anxiety were 23

   • Without anxiety: 23.4 e 30
   • With anxiety: greater than 30.

Secondary Outcome Measures :

1. Change From Baseline Parental Anxiety at Postinduction of Anesthesia [ Time Frame: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia ]

   The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)

   The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.

   The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.

   Higher scores are positively correlated with higher levels of anxiety.

   Each type of anxiety has its own scale of 20 different questions that are scored.

   Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Other Outcome Measures:

1. Postoperative Emergence Delirium [ Time Frame: at 20 minute in postanesthetic care unit ]

   The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit

   The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.

   CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs

   Interpretation:

   • minimum score: 4 = no pain
   • maximum score: 13 = the worst pain

   When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.

2. Postoperative Behavioral Changes [ Time Frame: 1. postoperative 2 days, 2 postoperative 14 days ]

   The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.

   The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.

   The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.

   Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 7 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 and 2
2. 1-7 years old.
3. elective, single minor surgery under general anesthesia

Exclusion Criteria:

1.Chronic illness, psychological or emotional disorder, abnormal cognitive development 2.Previous anesthetic experience 3.Closure both eyes after surgery 4.Sedative medication or psychoactive drugs medication, 5.History of allergy to the drugs used in our study 6.Expected difficult intubation or respiration such as abnormal airway, reactive airway disease, upper respiratory infection in recent 3 weeks

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Contacts and Locations

Locations

Korea, Republic of

Yeungnam University Hospital

Daegu, Korea, Republic of, 705-717

Sponsors and Collaborators

Yeungnam University College of Medicine

Investigators

• Principal Investigator: Sung Mee Jung, MD; Yeungnam University College of Medicine

More Information

Additional Information:

Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia 

Cartoon distraction alleviates anxiety in children during induction of anesthesia 

• Responsible Party: Sung Mee Jung, Associate professor, Yeungnam University College of Medicine
• ClinicalTrials.gov Identifier: NCT02027844
• Other Study ID Numbers: JUNG999ANXIETY
• First Posted: January 6, 2014
• Results First Posted: November 1, 2015
• Last Update Posted: November 1, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Psychomotor Agitation; Anxiety Disorders; Anxiety, Separation; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders