Discomfort During Intravenous Cannulation in an Emergency Department: Impact of Communication

NCT03502655 | Completed

• 1 other identifier: VVP01112017
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to investigate whether the communication between patients and healthcare providers has an impact on pain and anxiety induced by the insertion of a peripheral venous catheter in an emergency department. Another goal is to determine if the effect is mediated by the content of the message in itself or if it is mediated by non-verbal cues . Therefore, the message will be delivered by either an audio recording in the first phase of the study, and by the healthcare providers themselves in the second phase of the study. A secondary goal is to assess whether there are discrepancies between the patients' pain and anxiety reports and the healthcare providers' evaluation of the patient's pain and anxiety.

Conditions

Pain, Acute; Catheterization, Peripheral

Keywords

Pain; Peripheral intravenous catheter; Peripheral catheterization; Communication; Emergency Department

Outcome Measures

Primary Outcomes (2)

• Patients' self-evaluation of pain intensity and pain unpleasantness before the peripheral venous catheter's insertion (basal rates).

  Pain intensity and unpleasantness will be assessed via specifically created Visual Analog Scales on a small ruler. This ruler will be presented to the patients who will place the slider on a line going from one extreme to the other (no pain / worst pain imaginable) and corresponding, on their other side, to a value between 0 and 100 mm on a 100 mm long line. This numerical value measured in millimeters will be reported in the CRF by the co-investigators.

  Pain intensity and unpleasantness will be assessed immediately at the end of the procedure.

• Patients' self-evaluation of pain intensity and pain unpleasantness due to the insertion of a peripheral venous catheter.

  Pain intensity and unpleasantness will be assessed via specifically created Visual Analog Scales on a small ruler. This ruler will be presented to the patients who will place the slider on a line going from one extreme to the other (no pain / worst pain imaginable) and corresponding, on their other side, to a value between 0 and 100 mm on a 100 mm long line. This numerical value measured in millimeters will be reported in the CRF by the co-investigators.

  Pain intensity and unpleasantness due to the catheter's insertion will be assessed about two minutes after the peripheral venous catheter's insertion.

Secondary Outcomes (3)

• Patients' self-evaluation of anxiety before the peripheral venous catheter's insertion (basal rate).

  Anxiety will be assessed about ten minutes before the peripheral venous catheter's insertion.

• Patients' self-evaluation of anxiety after the peripheral venous catheter's insertion.

  Anxiety will be assessed about two minutes after the peripheral venous catheter's insertion.

• Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety.

  Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety will be assessed about ten minutes after the insertion of the peripheral venous catheter.

Study Arms (4)

Intervention message (first phase)

OTHER

Standardized message The intervention will consist in the delivery of a message with a positive content regarding the insertion of the peripheral venous catheter. The message will be delivered through an audio record

Other: Experimental: Intervention message (first phase)

Control message (first phase)

ACTIVE COMPARATOR

Standardized message The intervention will consist in the delivery of a control message, whose content is based upon the usual caregiver-patient communication prior to the insertion of a peripheral venous catheter. The message will be delivered through an audio record.

Other: Placebo Comparator: Control message (first phase)

Intervention message (second phase)

OTHER

Standardized message The intervention will consist in the delivery of message with a positive content regarding the insertion of the peripheral venous catheter. The message will be delivered by the health providers themselves before inserting the catheter.

Other: Experimental: Intervention message (second phase)

Control message (second phase)

ACTIVE COMPARATOR

Standardized message In this arm, the patient will be delivered a control message, which content is based upon the usual caregiver-patient communication prior to the insertion of a peripheral venous catheter. The message will be delivered by the caregivers themselves before inserting the catheter.

Other: Placebo Comparator: Control message (second phase)

Interventions

Experimental: Intervention message (first phase) OTHER

Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a recorded message

Intervention message (first phase)

Placebo Comparator: Control message (first phase) OTHER

Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a recorded message

Control message (first phase)

Experimental: Intervention message (second phase) OTHER

Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a care provider

Intervention message (second phase)

Placebo Comparator: Control message (second phase) OTHER

Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a care provider

Control message (second phase)

Eligibility Criteria

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

You may qualify if:

• Patient aged 18 or more;
• Patient whose medical care requires a peripheral venous catheter;
• Insertion of the peripheral venous catheter on the upper limb.

You may not qualify if:

• Patient clinically unstable;
• Patient incapable of discernment or with whom it is difficult to communicate (altered mental status, intoxication, alcoholized patient, insufficient French notions to give an informed consent and answer questions about pain and anxiety, hearing-impaired patient);
• Patient unable to correctly use the rulers (e.g. visually impaired patient);
• Impaired upper limb (e.g. lymphedema);
• Patient incarcerated;
• Patient transferred from another hospital;
• Patient who has already taken part in the study;
• Patient who knows beforehand that communication will be evaluated;
• Patient, caregiver or investigator who knows beforehand which message will be delivered (first phase of the study).

Sponsors & Collaborators

• Olivier Hugli: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (17)

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• Berna C, Favre-Bulle A, Bonzon A, Gross N, Gonthier A, Gerhard-Donnet H, Taffe P, Hugli O. Is Positive Communication Sufficient to Modulate Procedural Pain and Anxiety in the Emergency Department? A Randomized Controlled Trial. Psychosom Med. 2023 Nov-Dec 01;85(9):772-777. doi: 10.1097/PSY.0000000000001246. Epub 2023 Aug 24.

  PMID: 37678374 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain; Communication; Emergencies

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivier Hugli, PD-MER, MPH

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient allocation to each arm will be based on the sequential opening of an opaque envelope containing an non-consecutive number indicating a track number of the recorded message (control or intervention). Randomization will be based on randomly mixed block of size 2 to 6 patients.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the inpatient service, Emergency Department

Model Details: Each eligible patient will be randomized in a 1: 1 ratio between the two arms of the study, double-blind (patient, caregiver, investigator) in the first study and single-blind (patient) in the second study.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: April 19, 2018
• Study Start: December 13, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)