Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT05902585

Collaborator

(none)

Enrollment

Locations

Arms

8.2

Actual Duration (Months)

13.8

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality Pediatric ALL Pain, Procedural	Behavioral: Virtual reality	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial

Actual Study Start Date :

Feb 26, 2022

Actual Primary Completion Date :

Nov 2, 2022

Actual Study Completion Date :

Nov 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care In this arm, the analysis will be done in the usual way (for example, distracting with questions).
Active Comparator: Virtual reality In this arm, the analysis will be done while the children use virtual reality.	Behavioral: Virtual reality In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.

Arm

Intervention/Treatment

No Intervention: Usual care

In this arm, the analysis will be done in the usual way (for example, distracting with questions).

Active Comparator: Virtual reality

In this arm, the analysis will be done while the children use virtual reality.

Behavioral: Virtual reality

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

Outcome Measures

Primary Outcome Measures

Pain associated with venipuncture [1 day: The day of the venipuncture]
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
Anxiety [1 day: The day of the venipuncture]
Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.

Secondary Outcome Measures

Number of attempts for analytics [1 day: The day of the venipuncture]
1, 2, 3, 4, or 5
Time required for analysis [1 day: The day of the venipuncture]
Minutes
Difficulty level of the technique [1 day: The day of the venipuncture]
Easy, normal or difficult
Parents satisfaction [1 day: The day of the venipuncture]
1 = unsatisfied 10 = very satisfied
Nurse anxiety [1 day: The day of the venipuncture]
1 = totally calm 10 = very anxious

Other Outcome Measures

Pacient age at the moment of venipuncture [Before venipuncture]
In years
Pacient sex [Before venipuncture]
Male or female
Venipuncture in the last 6 months [Before venipuncture]
Venipuncture in the last 6 months
Parental presence at the moment of venipuncture [1 day: The day of the venipuncture]
Yes or not

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Salut de Castelló	Castelló	Valencia	Spain	46270
2	Centre de Salut de Carcer	Càrcer	Valencia	Spain	46294
3	Hospital General de Onteniente	Ontinyent	Valencia	Spain	46870
4	Centre de Salut de Pobla Llarga	Puebla Larga	Valencia	Spain	46670
5	Centre de Salut de Xàtiva	Xàtiva	Valencia	Spain	46800
6	Hospital Lluís Alcanyís	Xàtiva	Valencia	Spain	46800

Sponsors and Collaborators

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

Investigators

Principal Investigator: Raquel Gil Piquer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Raquel Gil Piquer, Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

ClinicalTrials.gov Identifier:

NCT05902585

Other Study ID Numbers:

37/2021

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Procedural

Study Results

No Results Posted as of Jun 15, 2023