Utvärdering av Paro, en terapeutisk assistentrobot i analgesisk hantering under placering av en perifer intravenös kateter hos spädbarn och barn. (PARO)
Utvärdering av Paro, en terapeutisk assistentrobot inom analgesibehandling vid placering av perifer intravenös linje hos spädbarn och barn, en multricenter randomiserad prospektiv studie.
Perifer intravenös kateterisering är en av de mest frekvent utförda procedurerna på barn på akutmottagningar och pediatriska enheter. Det orsakar ofta ångest för både barnet och dess föräldrar, vilket ökar smärtan i samband med själva ingreppet, eftersom rädsla och smärta är nära sammankopplade. Att hantera barnets smärta och ångest är avgörande för att optimera barnets välbefinnande på kort, medellång och lång sikt.
Kvaliteten på pediatrisk analgesi beror till stor del på det multimodala tillvägagångssättet för interventioner som erbjuds barn i smärta. Nyligen har flera icke-farmakologiska terapier för smärtlindring och ångestreducering utvecklats. Bland dessa tekniker har nya teknologier dykt upp, såsom terapeutiska assistansrobotar utrustade med artificiell intelligens, men deras terapeutiska fördelar måste fortfarande utvärderas.
Forskarna syftar därför till att genomföra en studie på PARO, en terapeutisk assistansrobot formad som en sälunge, för att utvärdera dess roll i smärtlindring under perifer venös kateterisering hos barn. Forskarna avser att jämföra de terapeutiska effekterna av PARO kombinerat med standardtekniker kontra enbart standardtekniker under smärtsamma procedurer. Målet är att avgöra om användningen av denna terapeutiska assistansrobot kan förbättra och optimera den övergripande hanteringen av barn som genomgår nålinducerade hudpunkteringar. Således planerar forskarna en multicenter, randomiserad, öppen, superioritetsstudie som genomförs på fem pediatriska centra. Forskarna syftar till att rekrytera 120 spädbarn och barn i åldern 12 månader till 7 år som kommer att genomgå perifer venös kateterisering. Smärta kommer att bedömas med FLACC-skalan (Face-Legs-Activity-Cry-Consolability) för heterobedömning i denna åldersgrupp.
Sekundära mål inkluderar att bedöma och jämföra stress i de två grupperna med hjälp av PRIC-verktyget (Procedural Restraint Intensity for Children), som mäter tvångsintensiteten, samt övervakning av hjärtfrekvensvariabilitet, antalet försök som krävs för att slutföra proceduren, föräldraångest via STAI-frågeformuläret (State-Trait Anxiety Inventory) och slutligen tillfredsställelsen hos både föräldrar och paramedicinsk personal.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: ALINE JOULIE, PHD
- Telefonnummer: +33492030520
- E-post: joulie.a@chu-nice.fr
Studera Kontakt Backup
- Namn: Jennifer BATTISTA, MD
- Telefonnummer: + 33 6 36 80 27 42
- E-post: battista.j@chu-nice.fr
Studieorter
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Brest, Frankrike
- Har inte rekryterat ännu
- CHU Morvan
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Kontakt:
- Elise SACAZE, MD
- Telefonnummer: +33 04.92.22.36.57
- E-post: elise.sacaze@chu-brest.fr
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Grasse, Frankrike
- Har inte rekryterat ännu
- Centre hospitaliers de Grasse
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Kontakt:
- Blandine DESSE, MD
- Telefonnummer: 04.92.09.75.41
- E-post: b.desse@chu-grasse.fr
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Nice, Frankrike
- Rekrytering
- Chu De Nice
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Kontakt:
- Jennifer Battista, MD
- Telefonnummer: +33492030039
- E-post: battista.j@chu-nice.fr
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Nice, Frankrike, 06000
- Rekrytering
- Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
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Kontakt:
- Aline JOULIE
- Telefonnummer: +33492030520
- E-post: joulie.a@chu-nice.fr
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Huvudutredare:
- Barabra LE GALLO, MD
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Toulouse, Frankrike, 31059
- Har inte rekryterat ännu
- Centre Hospitalier Universitaire Toulouse
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Kontakt:
- Camille Brehin, Pr
- Telefonnummer: +33 0534558420
- E-post: brehin.c@chu-toulouse.fr
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Huvudutredare:
- Camille Brehin, Pr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- är mellan 12 månader och 7 år gamla
- kräver perifer intravenös kateterisering (PIC)
- talar och förstår franska.
Exklusionskriterier:
- behov av kontaktisolering inklusive kolonisering eller infektion med multiresistenta bakterier (MRB),
- syn- eller hörselnedsättning;
- psykiatrisk patologi som kan försämra förståelsen;
- livshotande nödsituation;
- behovet av starkare smärtlindrande läkemedel (som Morfin, Ketamin och intranasala terapeutika).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Barbara LE GALLO, MD, Hôpitaux pédiatrique Nice CHU Lenval
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 24-HPNCL-05 PARO
- 2025-A00197-42 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
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