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This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.
It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.
Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality program group | Experimental | Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery. |
|
| control group | Active Comparator | standard perioperative care without virtual reality program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality glasses | Device | Children are encouraged to watch the virtual reality program at least 24 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Anxiety level | In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30 | baseline to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol level | In children: Saliva sample collection using Salivette system before the patient is transferred to the operating room. Levels over 8nmol/l can be caused by high anxiety level | baseline to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety levels | In parents: State Anxiety Inventory Scale, self questionnaire made of 20 questions rated from 0 to 3 at the holding area. Range from 1 up to 10 | baseline to 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Franco, MD | Contact | +34934978904 | 8904 | tfranco.germanstrias@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Franco | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teresa Franco | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Prospective randomized controlled trial
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| standard perioperative care without virtual reality program | Procedure | standard perioperative care without virtual reality program |
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |