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A Novel Electronic Method of Collecting Pain Scores in the Emergency Department (PIMPERNEL)

29. Januar 2020 aktualisiert von: University of Leicester

Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log (PIMPERNEL). A Randomised Controlled Trial of an Electronic Pain Score Display in Adults in the Emergency Department

Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.

The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.

The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

105

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
    • Leicestershire
      • Leicester, Leicestershire, Vereinigtes Königreich, LE1 5WW
        • Leicester Royal Infirmary

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • adult (18 years and over)
  • underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
  • likely to be staying in the hospital for at least 2 hours
  • willing and able to give informed consent
  • able to understand and speak a good level of English

Exclusion Criteria:

  • children (under 18 years)
  • patients not willing to undergo routine care (analgesic treatment)
  • patients who do not have capacity to consent
  • patients who are unwilling or unable to give informed consent
  • prisoners
  • patients who cannot understand the study information in English
  • currently participating in another clinical trial as far as can be determined from information available at the time of assessment
  • patients who have a physical or visual disability which will prevent them from holding or using the pain display

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: PIMPERNEL Novel Electronic Log - intervention

The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level.

The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).
Sonstiges: PIMPERNEL Novel Electronic Log: Pain display can be seen
Pain scores are displayed on the screen when the participant presses the corresponding button
Sonstiges: PIMPERNEL Novel Electronic Log - control

The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level.

The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).
Sonstiges: PIMPERNEL Novel Electronic Log: Pain display is hidden
Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain reported by the patient:11 point numerical pain scale
Zeitfenster: Up to 6 hours
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Up to 6 hours

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of possible scores recorded by patients
Zeitfenster: Up to 6 hours
Up to 6 hours
Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
Zeitfenster: Up to 6 hours
The scores recorded by the participants at 2 and 4 hours into their hospital stay will be compared with the scores recorded by nursing staff in the electronic record. The 11 point numerical rating scale is used for both measurements. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Up to 6 hours
Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
Zeitfenster: Up to 6 hours
Up to 6 hours
Recording time to second dose of analgesia and whether there is a pattern to this
Zeitfenster: Up to 6 hours
Up to 6 hours
Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
Zeitfenster: Up to 6 hours
The dose, time prescribed, time administered and name of analgesia given pre-hospital and whilst in hospital will be recorded and a comparison made between the groups. This is a feasibility study only so exact outcome depends upon what data can be collected.
Up to 6 hours
Opinion of patients
Zeitfenster: Up to 6 hours

Uses a short (4 question) questionnaire designed for this study. Questions on ease of use, whether the monitor is a good idea, whether participants would use it again in the future and whether it improved their experience as a patient, plus a comments box.

Questions: 1) How easy was it to use the pain monitor? (very easy, easy, no opinion, difficult, very difficult) 2) I think that the pain monitor is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) I would use the monitor again in the future (strongly agree, agree, no opinion, disagree, strongly disagree) 4) The pain monitor improved my experience as a patient (strongly agree, agree, no opinion, disagree, strongly disagree)
Up to 6 hours
Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
Zeitfenster: Up to 6 hours

Short (4 question) questionnaire designed for the study. Questions on whether the display is practical to use in the Emergency Department, whether they think it is a good idea, whether it is likely to improve the patient experience and whether a patient used the display to get their attention for a reason other than pain. Also has a comments box.

Questions: 1) The pain display is practical to use in the Emergency Department (strongly agree, agree, no opinion, disagree, strongly disagree) 2) I think that the pain display is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) The pain display is likely to improve the patient experience (strongly agree, agree, no opinion, disagree, strongly disagree) 4) A patient used the pain display to get my attention for a reason other than pain (yes, not sure, no)
Up to 6 hours
Opinion of researchers regarding any likely stratification needs
Zeitfenster: Up to 6 hours
Subjective opinion of researchers having completed the study on whether stratification would be required in future studies. No specific measurement used.
Up to 6 hours

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Leicester

Ermittler

  • Hauptermittler: Timothy J Coats, Prof, University of Leicester

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. August 2017

Primärer Abschluss (Tatsächlich)

31. Juli 2019

Studienabschluss (Tatsächlich)

31. Juli 2019

Studienanmeldedaten

Zuerst eingereicht

28. Januar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. März 2019

Zuerst gepostet (Tatsächlich)

20. März 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Januar 2020

Zuletzt verifiziert

1. Januar 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0588
  • IRAS 210798 (Andere Kennung: IRAS)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Beschreibung des IPD-Plans

We are collecting feasibility data only in this trial.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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