NCT05902585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 15, 2023

Last Update Submit

June 9, 2023

Conditions

Virtual RealityPediatric ALLPain, Procedural

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Number of attempts for analytics

    1 day: The day of the venipuncture

  • Time required for analysis

    1 day: The day of the venipuncture

  • Difficulty level of the technique

    1 day: The day of the venipuncture

  • Parents satisfaction

    1 day: The day of the venipuncture

  • Nurse anxiety

    1 day: The day of the venipuncture

Other Outcomes (4)

  • Pacient age at the moment of venipuncture

    Before venipuncture

  • Pacient sex

    Before venipuncture

  • Venipuncture in the last 6 months

    Before venipuncture

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: Virtual reality

Interventions

Virtual realityBEHAVIORAL

In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.

Virtual reality

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
  • Consent to participate by signing the informed consent.

You may not qualify if:

  • Children younger than 7 years old.
  • Children older than 12 years old.
  • Children that don't sign the informed consent.
  • Children with psychomotor and neurocognitive delay.
  • Children with visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre de Salut de Castelló

Castellon, Valencia, 46270, Spain

Location

Centre de Salut de Carcer

Càrcer, Valencia, 46294, Spain

Location

Centre de Salut de Pobla Llarga

La Pobla Llarga, Valencia, 46670, Spain

Location

Hospital General de Onteniente

Ontinyent, Valencia, 46870, Spain

Location

Centre de Salut de Xàtiva

Xàtiva, Valencia, 46800, Spain

Location

Hospital Lluís Alcanyís

Xàtiva, Valencia, 46800, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPain, Procedural

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raquel Gil Piquer

    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 15, 2023

Study Start

February 26, 2022

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

ES(6)