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The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.
Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.
The satisfaction of parents and nursing will also be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | In this arm, the analysis will be done in the usual way (for example, distracting with questions). | |
| Virtual reality | Active Comparator | In this arm, the analysis will be done while the children use virtual reality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Behavioral | In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain associated with venipuncture | Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain. | 1 day: The day of the venipuncture |
| Anxiety | Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient. | 1 day: The day of the venipuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts for analytics | 1, 2, 3, 4, or 5 | 1 day: The day of the venipuncture |
| Time required for analysis | Minutes | 1 day: The day of the venipuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Pacient age at the moment of venipuncture | In years | Before venipuncture |
| Pacient sex | Male or female | Before venipuncture |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquel Gil Piquer | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Salut de Castelló | Castellon | Valencia | 46270 | Spain | ||
| Centre de Salut de Carcer |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2021 |
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Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
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| Difficulty level of the technique | Easy, normal or difficult | 1 day: The day of the venipuncture |
| Parents satisfaction | 1 = unsatisfied 10 = very satisfied | 1 day: The day of the venipuncture |
| Nurse anxiety | 1 = totally calm 10 = very anxious | 1 day: The day of the venipuncture |
| Venipuncture in the last 6 months | Venipuncture in the last 6 months | Before venipuncture |
| Parental presence at the moment of venipuncture | Yes or not | 1 day: The day of the venipuncture |
| Càrcer |
| Valencia |
| 46294 |
| Spain |
| Centre de Salut de Pobla Llarga | La Pobla Llarga | Valencia | 46670 | Spain |
| Hospital General de Onteniente | Ontinyent | Valencia | 46870 | Spain |
| Centre de Salut de Xàtiva | Xàtiva | Valencia | 46800 | Spain |
| Hospital Lluís Alcanyís | Xàtiva | Valencia | 46800 | Spain |
| Jun 9, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2021 | Jun 9, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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