Not provided
Not provided
Not provided
Not provided
Recruiting process could not be completed; lack of participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthopaedic Intervention group | Experimental | 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. |
|
| Orthopaedic Control group | No Intervention | Gets written and oral preparation for surgery | |
| Urologic Intervention group | Experimental | 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. |
|
| Urologic Control group | No Intervention | Gets written and oral preparation for surgery | |
| General Paediatric Surgery Intervention group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-Operative Preparatory Virtual Reality Program | Other | The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perioperative anxiety level of Children VFAS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thoralf Randolf Liebs, PD Dr. med | Department of Pediatric Surgery, Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern, Clinic for Pediatric Surgery | Bern | 3010 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Prospective randomized, controlled trial
Not provided
Not provided
Not provided
| General Paediatric Surgery Control group | No Intervention | Gets written and oral preparation for surgery |
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 |
| 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 |
| 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 |