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

NCT03881982 | Completed

• 2 other identifiers: 0588IRAS 210798
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Pain reported by the patient:11 point numerical pain scale

  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

Secondary Outcomes (8)

• Proportion of possible scores recorded by patients

  Up to 6 hours

• Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours

  Up to 6 hours

• Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay

  Up to 6 hours

• Recording time to second dose of analgesia and whether there is a pattern to this

  Up to 6 hours

• Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)

  Up to 6 hours

Study Arms (2)

PIMPERNEL Novel Electronic Log - intervention

EXPERIMENTAL

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).

Other: PIMPERNEL Novel Electronic Log: Pain display can be seen

PIMPERNEL Novel Electronic Log - control

OTHER

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).

Other: PIMPERNEL Novel Electronic Log: Pain display is hidden

Interventions

PIMPERNEL Novel Electronic Log: Pain display can be seen OTHER

Pain scores are displayed on the screen when the participant presses the corresponding button

PIMPERNEL Novel Electronic Log - intervention

PIMPERNEL Novel Electronic Log: Pain display is hidden OTHER

Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).

PIMPERNEL Novel Electronic Log - control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Publications (14)

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  PMID: 7594383 BACKGROUND

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  PMID: 17306626 BACKGROUND

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  PMID: 21197290 BACKGROUND

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  PMID: 15039693 BACKGROUND

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  PMID: 19321506 BACKGROUND

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  BACKGROUND

• Menendez ME, Bot AG, Hageman MG, Neuhaus V, Mudgal CS, Ring D. Computerized adaptive testing of psychological factors: relation to upper-extremity disability. J Bone Joint Surg Am. 2013 Oct 16;95(20):e149. doi: 10.2106/JBJS.L.01614.

  PMID: 24132364 BACKGROUND

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  PMID: 23418302 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy J Coats, Prof

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: March 20, 2019
• Study Start: August 3, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 30, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)