An interventional study of Pre-Operative Preparatory Virtual Reality Program in Surgery and Anxiety, sponsored by Thoralf Liebs. Terminated at 1 site in Switzerland. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by Thoralf Liebs · Not applicable, Interventional, and Other
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?
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Thoralf Liebs as lead sponsor.
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Exclusion Criteria:
In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.
Other: Pre-Operative Preparatory Virtual Reality Program
Gets written and oral preparation for surgery
In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.
Other: Pre-Operative Preparatory Virtual Reality Program
Gets written and oral preparation for surgery
In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.
Other: Pre-Operative Preparatory Virtual Reality Program
Gets written and oral preparation for surgery
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
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.
Time frame: 2 - 90 days after recruiting
Perioperative anxiety level of Children VAS-A
Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
Time frame: 2 - 90 days after recruiting
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")
Time frame: 2 - 90 days after recruiting
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
Time frame: 14 - 110 days after recruiting
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.
Time frame: 14 - 110 days after recruiting
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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