- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03787147
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI) (VR adult)
12 januari 2021 uppdaterad av: Sayed Wahezi, Albert Einstein College of Medicine
A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Adult requiring Spinal Injections
- Adult > 18years
- Adults with intact vision who can attend VR intervention
Exclusion Criteria:
- Anyone < 18 years
- Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- Adults who request moderate IV sedation
- Adults with photic-induced seizures
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
|
Aktiv komparator: Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
Aktiv komparator: Oculus
Adults receiving SI while using VR with Oculus Rift.
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain intensity as measured by the Visual Analog Scale
Tidsram: Immediately after receiving spinal injection
|
Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS).
The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).
|
Immediately after receiving spinal injection
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Anxiety Level as measured by the Visual Facial Anxiety Scale
Tidsram: Immediately after receiving spinal injection
|
Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS).
The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).
|
Immediately after receiving spinal injection
|
Heart rate as measured by the Empatica E4 wristband
Tidsram: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Systolic Blood Pressure as measured by the Empatica E4 wristband
Tidsram: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Diastolic Blood Pressure as measured by the Empatica E4 wristband
Tidsram: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Sympathetic skin response as measured by the Empatica E4 wristband
Tidsram: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Sympathetic skin response before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Temperature as measured by the Empatica E4 wristband
Tidsram: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Temperature before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Sayed Wahezi, MD, Albert Einstein College Of Medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
30 november 2020
Primärt slutförande (Förväntat)
1 december 2020
Avslutad studie (Förväntat)
1 december 2020
Studieregistreringsdatum
Först inskickad
5 december 2018
Först inskickad som uppfyllde QC-kriterierna
21 december 2018
Första postat (Faktisk)
26 december 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Medel mot arytmi
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Sensoriska systemagenter
- Bedövningsmedel
- Membrantransportmodulatorer
- Anestesimedel, lokal
- Spänningsstyrda natriumkanalblockerare
- Natriumkanalblockerare
- Lidokain
- Bupivakain
Andra studie-ID-nummer
- 2018-9613
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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