Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.

NCT05042479 | Completed

• 1 other identifier: RC21_0008
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences. During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc…) Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment. In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia. Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures. Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures. The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures. Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures. The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.

Conditions

Hematologic Malignancy; Hematologic Non Malignancy; Solid Tumor, Childhood; Child, Only

Keywords

Pediatric; Pediatric oncology; Pain; Virtual reality; Nurse

Outcome Measures

Primary Outcomes (3)

• Pain level measured by VAS (self-evaluation) during the first care using standard treatment.

  Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.

  Immediately after the first care.

• Pain level measured by VAS (self-evaluation) during the second care using virtual reality

  Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.

  Immediately after the second care .

• Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment

  Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.

  Immediately after the third care .

Secondary Outcomes (6)

• Percentage of children who choose VR in the 3rd care

  Immediately after the 3rd intervention.

• Patient questionnaire

  Immediately after the 3rd intervention.

• Side effects to the use of VR

  During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.

• Ethnographic approach to caregivers' experiences after using the VR headset.

  Through study completion - up to 20 months.

• parent questionnaire.

  Immediately after the 3rd intervention.

Study Arms (1)

Standard treatment then virtual reality then choice between the two

EXPERIMENTAL

Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement. For the 3rd treatment, the child will choose his/her favorite technique.

Other: Usual distraction and pain prevention techniques.; Other: Virtual reality; Other: Choice between usual distraction or virtual reality

Interventions

Usual distraction and pain prevention techniques. OTHER

For the first painful procedure, the child will benefit usual distraction and pain prevention techniques.Pain prevention and management techniques commonly used in the conduct of care: * Application of a patch or anaesthetic cream 1 hour before the treatment * Vigilant sedation using a premedication for lumbar punctures: Midazolam /Nalbuphine/Hydroxyzine/Morphine. * Apart from care using VR, MEOPA can be given to the child for all assessed care on prescription. * Apart from care using VR, the usual distraction techniques are left to the patient's choice (electronic tablet, smartphone, games, songs...) * The presence of the parents

Standard treatment then virtual reality then choice between the two

Virtual reality OTHER

For the 2nd painful procedure, the child will use a VR (virtual reality) headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.

Standard treatment then virtual reality then choice between the two

Choice between usual distraction or virtual reality OTHER

For the 3rd painful procedure, the child will choose his/her favorite technique between : Usual distraction and pain prevention techniques or virtual reality

Standard treatment then virtual reality then choice between the two

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Quantitative component:
• Child aged 7 to 18 years
• Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management.
• Child who has already experienced a potentially painful care procedure before entry the study
• Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care.
• Child with consent.
• Child whose parental authority holders have given their consent to participate to the study.
• Qualitative component:
• Professional who used both care-induced pain prevention techniques and agreed to be interviewed.
• A parent or guardian.

You may not qualify if:

• Child who refuse to use this distraction technique (VR).
• Child who refuse to not use MEOPA during VR.
• Child who does not speak French and whose parents do not speak French

Sponsors & Collaborators

• Nantes University Hospital: lead
• For Ever Fabien: collaborator

Study Sites (1)

Nantes CHU

Nantes, 44000, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 13, 2021
• Study Start: June 30, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 24, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

FR (1)