Evaluering av Paro, en terapeutisk assistanserobot i analgesisk behandling under plassering av perifer intravenøs linje hos spedbarn og barn. (PARO)
Evaluering av Paro, en terapeutisk assistanserobot i analgesisk behandling under plassering av perifer intravenøs linje hos spedbarn og barn, en multikenter randomisert prospektiv studie.
Perifer intravenøs kateterisering er en av de hyppigst utførte prosedyrene hos barn på akutten og i pediatriske avdelinger. Den forårsaker ofte angst både for barnet og foreldrene, noe som øker smerten forbundet med selve prosedyren, siden frykt og smerte er nært knyttet sammen. Å håndtere barnets smerte og angst er avgjørende for å optimalisere barnets velvære på kort, mellomlang og lang sikt.
Kvaliteten på pediatrisk analgesi avhenger i stor grad av den multimodale tilnærmingen til intervensjoner som tilbys barn i smerte. Nylig har flere ikke-farmakologiske terapier for smertelindring og angstreduksjon blitt utviklet. Blant disse teknikkene har nye teknologier dukket opp, som terapeutiske assistenteroboter utstyrt med kunstig intelligens, men deres terapeutiske fordeler må fortsatt vurderes.
Forskerne har derfor som mål å gjennomføre en studie på PARO, en terapeutisk assistenterobot formet som en selunge, for å evaluere dens rolle i smertelindring under perifer venøs kateterisering hos barn. Forskerne har til hensikt å sammenligne de terapeutiske effektene av PARO kombinert med standardteknikker versus standardteknikker alene under smertefulle prosedyrer. Målet er å fastslå om bruken av denne terapeutiske assistenteroboten kan forbedre og optimalisere den overordnede behandlingen av barn som gjennomgår nåleindusert hudpunktering. Dermed planlegger forskerne en multisentrisk, randomisert, åpen, overlegenhetsstudie utført i fem pediatriske sentre. Forskerne har som mål å rekruttere 120 spedbarn og barn i alderen 12 måneder til 7 år som skal gjennomgå perifer venøs kateterisering. Smerte vil bli vurdert ved hjelp av FLACC (Face-Legs-Activity-Cry-Consolability) heterovurderingsskala i denne aldersgruppen.
Sekundære mål inkluderer å vurdere og sammenligne ubehag i de to gruppene ved hjelp av PRIC (Procedural Restraint Intensity for Children) verktøyet, som måler tvangsintensiteten, samt overvåking av hjertefrekvensvariabilitet, antall forsøk som kreves for å fullføre prosedyren, foreldreangst via STAI (State-Trait Anxiety Inventory) spørreskjemaet, og til slutt, tilfredsheten til både foreldre og paramedisinsk personell.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: ALINE JOULIE, PHD
- Telefonnummer: +33492030520
- E-post: joulie.a@chu-nice.fr
Studer Kontakt Backup
- Navn: Jennifer BATTISTA, MD
- Telefonnummer: + 33 6 36 80 27 42
- E-post: battista.j@chu-nice.fr
Studiesteder
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Brest, Frankrike
- Har ikke rekruttert ennå
- CHU Morvan
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Ta kontakt med:
- Elise SACAZE, MD
- Telefonnummer: +33 04.92.22.36.57
- E-post: elise.sacaze@chu-brest.fr
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Grasse, Frankrike
- Har ikke rekruttert ennå
- Centre hospitaliers de Grasse
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Ta kontakt med:
- Blandine DESSE, MD
- Telefonnummer: 04.92.09.75.41
- E-post: b.desse@chu-grasse.fr
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Nice, Frankrike
- Rekruttering
- Chu De Nice
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Ta kontakt med:
- Jennifer Battista, MD
- Telefonnummer: +33492030039
- E-post: battista.j@chu-nice.fr
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Nice, Frankrike, 06000
- Rekruttering
- Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
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Ta kontakt med:
- Aline JOULIE
- Telefonnummer: +33492030520
- E-post: joulie.a@chu-nice.fr
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Hovedetterforsker:
- Barabra LE GALLO, MD
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Toulouse, Frankrike, 31059
- Har ikke rekruttert ennå
- Centre Hospitalier Universitaire Toulouse
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Ta kontakt med:
- Camille Brehin, Pr
- Telefonnummer: +33 0534558420
- E-post: brehin.c@chu-toulouse.fr
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Hovedetterforsker:
- Camille Brehin, Pr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- er mellom 12 måneder og 7 år gamle
- trenger perifer intravenøs kateterisering (PIC)
- snakker og forstår fransk.
Eksklusjonskriterier:
- behov for kontaktsisolering inkludert kolonisering eller infeksjon med multiresistente bakterier (MRB),
- syns- eller hørselshemming;
- psykiatrisk patologi som kan hemme forståelsen;
- livstruende nødsituasjon;
- behov for sterkere smertestillende medisiner (som Morfin, Ketamin og intranasale terapeutika).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Control group : standard multimodal stratgey
The child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin prior to the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, the child will inhale the gas via a mask during the procedure. Non-pharmacological interventions, such as music therapy and/or watching cartoons, may also be used as part of standard care. The procedure will begin with skin disinfection and identification of a suitable vein. For the purposes of the study, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure is considered complete once the needle is withdrawn and a dressing is applied. |
Pharmacological interventions: EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) EMLA cream (Eutectic Mixture of Local Anesthetics) Non-pharmacological interventions: Music therapy Audiovisual distraction (e.g., watching cartoons) |
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Eksperimentell: Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti
The child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used to reduce pain, it will be applied to the skin 30 to 60 minutes prior to the procedure. To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child. The procedure will begin with skin disinfection and identification of a suitable vein. For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure will be considered complete once the needle is withdrawn and a dressing is applied. |
The child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin 30 to 60 minutes prior to the procedure. To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child during the procedure. The procedure will begin with skin disinfection and identification of a suitable vein. For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure will be considered complete once the needle is withdrawn and a dressing is applied.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization
Tidsramme: periprocedural
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The effectiveness of PARO in reducing procedural pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale. The FLACC is a validated hetero-assessment tool for evaluating pain in children aged 12 months to 7 years, particularly in the context of acute postoperative pain and brief painful medical procedures. This scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates a relaxed and comfortable child, while scores of 7 to 10 indicate severe pain or significant distress. A score of ≥3 is commonly considered indicative of clinically relevant pain requiring analgesic intervention. |
periprocedural
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization
Tidsramme: skin disinfection AND Skin penetration
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Children's distress will be evaluated using the PRIC scale (Procedural Restraint Intensity in Children), which measures the intensity of restraint required during pediatric procedures as an indirect indicator of procedural distress.
The scale is stratified into five levels, assessing both the degree of physical restraint applied and the child's behavioral response.
A score ≥3 is considered clinically significant and should prompt reassessment of pain and/or anxiolytic management.
The PRIC scale has been preliminarily validated in a cohort of 20 children aged 2 months to 13 years, showing acceptable metrological properties; however, further studies are ongoing to confirm its validity in real-life clinical settings, as no gold standard currently exists.
Procedural distress will be assessed at two time points: during skin disinfection with identification of the puncture site, and at skin penetration.
Results will be compared between groups
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skin disinfection AND Skin penetration
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Number of attempts required for successful peripheral venous access
Tidsramme: During the procedure (up to 3 attempts)
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The effectiveness of the procedure will also be assessed by the number of attempts required to establish peripheral venous access.
An attempt is defined as each skin puncture attempt.
For ethical reasons, a maximum of three attempts will be permitted; beyond this threshold, the procedure will be considered a failure and alternative management in the operating room will be proposed.
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During the procedure (up to 3 attempts)
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Assessment of parental satisfaction
Tidsramme: 15 minutes after the end of the procedure
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Parental satisfaction will be evaluated using a structured questionnaire administered to parents following the procedure.
The instrument includes four items rated on a Likert-type response scale.
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15 minutes after the end of the procedure
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Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI)
Tidsramme: at the end of the procedure
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Parental anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI is a self-administered questionnaire consisting of 40 items divided into two subscales: the State Anxiety subscale (STAI Form Y-1), which assesses current anxiety levels, and the Trait Anxiety subscale (STAI Form Y-2), which assesses general predisposition to anxiety. Each item is rated on a 4-point Likert scale, with scores ranging from 1 (low anxiety) to 4 (high anxiety). |
at the end of the procedure
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Failure of peripheral venous access after three attempts
Tidsramme: periprocedural
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Failure of peripheral intravenous catheterization is defined as the inability to establish venous access after a maximum of three attempts, as previously defined, necessitating management by the anesthesia team.
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periprocedural
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Assessment of paramedical staff satisfaction
Tidsramme: 15 minutes after the end of the procedure.
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Satisfaction of the paramedical team will be assessed using a dedicated questionnaire administered to all nursing staff involved in the study at the end of the trial. The questionnaire will be completed once by each participant and consists of four items rated on a Likert-type scale. In addition, one or more debriefing meetings will be organized with the care team at study completion to gather qualitative feedback regarding their experience and perceptions of the intervention |
15 minutes after the end of the procedure.
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Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization
Tidsramme: periprocedural
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Heart rate variability may serve as an indirect indicator of pain intensity, reflecting autonomic (sympathetic and parasympathetic) responses to nociceptive stimulation. Heart rate is a recognized physiological marker of pain in infants and children and may increase by approximately 10 to 25 beats per minute during painful procedures. In this study, heart rate will be used to assess the effect of PARO on procedural pain. It will be continuously monitored using standard clinical monitoring equipment. Measurements will be recorded at two time points: 15 minutes before the procedure during PARO introduction (if applicable), and at the time of venipuncture. The primary analysis will focus on the change (delta) in heart rate between baseline (15 minutes before the procedure) and venipuncture. Comparisons will be made between study groups. |
periprocedural
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Barbara LE GALLO, MD, Hôpitaux pédiatrique Nice CHU Lenval
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-HPNCL-05 PARO
- 2025-A00197-42 (Annen identifikator: ANSM)
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