Pediatric Preoperative Virtual Reality Program

Anxiety Clinical Trial

— PPVRP  

Official title:

The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03957525
• Other study ID #: 2019-00081
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does the introduction of a preparatory virtual reality (VR) program that is used in the home environment, have an effect on the anxiety level of children immediately before surgery, prior to administration of preoperative sedatives?

Description:

Up to 60% of children who require elective surgery report significant anxiety in the preoperative setting. Severe perioperative anxiety of a child poses a major challenge for the surgeon, since it is often accompanied by adverse behavioral and emotional reactions and associated with a complicated operative and postoperative course.

The investigators have made the personal experience that informing the children ahead of time about what to expect in the hospital, decreases child anxiety and increases parent satisfaction.

There is considerable debate on the best way how to inform children about what to expect during their hospital stay. The investigators had a virtual reality application developed that introduces the children to several aspects of the hospital environment. Therefore, these children now ahead of time what they will experience during their hospital stay.

The aim is to evaluate the effect of this preparatory virtual reality application on the anxiety level of children immediately before surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

Inclusion Criteria:

1. The child is between the age of 7 and 13 years

2. The child is undergoing an elective surgical procedure under general anesthesia

3. The child understands Swiss German

4. The parent(s) understand(s) German

5. The parent(s) possess a smart phone

6. Internet access is given

7. The patient information has been explained

8. Informed Consent is signed

Exclusion Criteria:

1. The child has a hearing impairment

2. The child has neurologic disorder

3. The child requires postoperative intensive care

4. The child has previous experience of anesthesia

5. American Society of Anesthesiologists (ASA) score of III or greater

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Surgery

Intervention

Other:
• Pre-Operative Preparatory Virtual Reality Program
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery

Locations

Country	Name	City	State
Switzerland	Inselspital Bern, Clinic for Pediatric Surgery	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Thoralf Liebs

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative anxiety level of children immediately before surgery (VAS-A)	Perioperative anxiety level of children as measured by the Visual Analog Scale for Anxiety (VAS-A), immediately before surgery, prior to administration of preoperative sedatives (T2).; The VAS-A scale consists of a 10 cm long, horizontal line, supplemented by two labels: "no anxiety or fear" at the left end, "worst possible anxiety or fear" at the right end of the scale.	2 - 90 days after recruiting
Secondary	Perioperative anxiety level of Children VAS-A	Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.	2 - 90 days after recruiting
Secondary	Perioperative anxiety level of Children VFAS	Perioperative anxiety level of children as measured by the Visual Faces Analog Scale (VFAS) scale at T0, T1, T2 and T3.; The VFAS scale consists of six different drawings of faces, supplemented by labels as follows: ("Anxiety Level:", "none", "mild", "mild-moderate", "moderate", "moderate-high", "highest")	2 - 90 days after recruiting
Secondary	Perioperative anxiety level of accompanying parent	Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale	14 - 110 days after recruiting
Secondary	Non-disease specific secondary Outcomes	The investigators want to evaluate to which extent the VR program is able to improve the patient and parent's level of preparedness for surgery. Unfortunately, there are currently no validated outcome measures available covering these issues. Therefore, we developed a questionnaire assessing the level of preparedness related to seven aspects of the hospital stay, which are particularly illustrated by the VR program.	14 - 110 days after recruiting