Reduction of Perioperative Anxiety Using a Hand-held Video Game Device

NCT04950088 | Completed

• 1 other identifier: Pro00057182
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Distraction techniques, such as use of a virtual reality device, have been used to augment or replace pharmacological practices for relief of anxiety in pediatric patients prior to surgical procedures. This relief can not only benefit medical staff, as procedures may be easier to perform and require less time, but also have a calming effect on the the parent during the procedure if they feel that their child is being better cared for. In addition, decreased anxiety prior to surgical procedures have been shown to reduce maladaptive behaviors post-operatively. This prospective study plans to evaluate the anxiety level of parents and pediatric patients in an outpatient surgery center pre-, during and post-operatively with and without the use of a virtual reality distraction device. The goal is to determine the existence of correlations between distraction techniques (in this case, the use of handheld video games) pediatric patient anxiety, parental anxiety, and parental satisfaction with the experience surrounding the procedure.

Conditions

Separation Anxiety; Anxiety; Anxiety, Separation; Anxiety Generalized

Keywords

anxiety; separation fear

Outcome Measures

Primary Outcomes (4)

• Change in pediatric anxiety score

  The modified Yale Preoperative Anxiety Scale16 (mYPAS): evaluated changes in pediatric anxiety with higher anxiety=higher score. mYPAS completed by nurses during initial preoperative evaluation, upon patient separation from parent and at mask induction. All three surveys were identical. A. Activity scored 1-4; B. Vocalizations scored 1-6; C. Emotional expressivity scored 1-4; D. State of apparent arousal scored 1-4

  at three timepoints in the peri-operative suite prior to induction for surgery

• Change in parent anxiety score

  The Strait-Trait Anxiety Inventory (STAI)17 assessed self-reported parental anxiety (below). The STAI was completed by the parent immediately after separation in the waiting room. STAI consists of two parts: A= perceived anxiety during the child's perioperative period; B= the parent's general state of anxiety. Differences between these two metrics were used to indicate parental satisfaction with their experience. The A questions were evaluated with the following scale (1-4) utilizing the descriptors 'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements. The B section regarding generalized anxiety was measured as follows (1-4) utilizing the descriptors 'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements different from the A section. The final question is as follows (Y/N): 8\. The experience of separation from my child for this procedure was better than expected. Y N

  Immediately following separation from the child; change in anxiety from baseline

• Overall Parental Satisfaction with the pre-operative process, particularly regarding parent/child separation

  To evaluate overall satisfaction of parents with the pre-operative process specifically, a final question was added to the STAI which inquired if the parent/guardian thought that the experience of separation was better or worse than was expected. This question was scored independently.

  Immediately following separation from the child

• Change in post-operative behavior as assessed by the parent

  The PHBQ queried change in perceived patient's behavior before and after the procedure with an inquiry regarding new-onset negative behaviors manifesting post-surgery. Three attempts were made to gather survey information for each time-point; if a parent could not be reached, data collection for that patient was truncated. Each of the three follow-up calls were completed utilizing the same protocol. The protocol consisted of 10 questions regarding the child's behavior with parent answers utilizing the following scale: much less less same more much more The final question was a rank from 1-10 with 10 being the worst (highest) score: 11\. On a scale from 1 to 10, 1 being no pain and 10 being more pain, how would you rate your child's current pain level? 1 2 3 4 5 6 7 8 9 10

  24-48 hours, 7 days and 14 days post procedure

Study Arms (2)

Game

ACTIVE COMPARATOR

Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.

Other: Hand-held video game device

no game

ACTIVE COMPARATOR

Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.

Other: Hand-held video game device

Interventions

Hand-held video game device OTHER

Game; no game

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• outpatient pediatric surgery patients between July 2016 and October 2016.
• Children, (ages 3-10 years) undergoing low-risk outpatient surgical procedures, including, but not limited to, tonsillectomies, adenoidectomies, etc., for which a masked induction was planned
• guardians of the children had to be present and consent.

You may not qualify if:

• patients undergoing ear tube placement/removal (due to the short duration of the procedure)
• patients requiring premedication
• patients with physical or mental disabilities rendering it difficult to use the distraction device
• non-English speaking caregivers (due to the language barriers during the post-operative phone calls).
• patients without guardians providing consent

Sponsors & Collaborators

• Prisma Health-Upstate: lead

MeSH Terms

Conditions

Anxiety, Separation; Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participants didn't know if it was 'game day' or 'no game day' but were consented to fill out surveys regardless of the status of game day. Care providers provided games on game day or didn't provide games on 'no game day' but didn't have foreknowledge of which participants had consented to the study until they reached the peri-operative suite.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 6, 2021
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 6, 2021

Record last verified: 2021-06