Discomfort During Intravenous Cannulation in an Emergency Department: Impact of Communication (DOUCIP)
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| ClinicalTrials.gov Identifier: NCT03502655 |
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Recruitment Status :
Completed
First Posted : April 19, 2018
Last Update Posted : July 7, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Acute Catheterization, Peripheral | Other: Experimental: Intervention message (first phase) Other: Placebo Comparator: Control message (first phase) Other: Experimental: Intervention message (second phase) Other: Placebo Comparator: Control message (second phase) | Not Applicable |
A medical or surgical emergency is a stressful life event. An emergency department is also a noisy and sometimes chaotic environment, contributing in itself to increase the anxiety related to the primary cause of the emergency consultation. Some common medical procedures, such as placing an intravenous catheter, may not only induce pain, but may exacerbate patients' anxiety or pre-existing pain. The well-being of patients, especially during invasive medical procedures, can however be improved by various communication techniques. However, the medical literature and clinical observation have shown that negative words are traditionally used to warn patients of an impending painful stimulus. However, contrary to common beliefs and practices, this type of warning can increase pain and anxiety. Using words with negative emotional content has an even greater impact than the positive impact of using words with positive emotional content. However, studies that have explored the impact of such messages suffer from two limitations: first, they were not conducted in the context of emergency department, and second, the effect attributable to healthcare providers themselves was not studied. However, healthcare providers who deliver a message with a positive or negative content in the context of a study are not blinded to message, therefore are aware of the arm of the intervention. This lack of double-blinding may introduces a bias, namely that the benefit of a positive message can be linked to healthcare providers and their global interaction with patients, and not just to verbal content. of the message. It is indeed possible that the caregivers, in a more or less conscious way, add in their communication elements congruent with the message studied, whether in the field of verbal or nonverbal communication (tone of voice, warmth, empathy , etc.).
The purpose of this study is therefore to investigate whether the modulation of information relating to the setting up of a CIP in emergencies has an impact on patients' pain and their level of anxiety. It also seeks to determine if this effect is comparable, whether the message is delivered by a standardized audio recording or by caregivers. Finally, it aims to explore whether there are differences in the assessment of pain and anxiety made by patients and that made by caregivers.
Statistical analysis will be realized using the Stata software, version 14 (StataCorp, Tx, USA). Descriptive data will be presented by mean and standard deviation, median and interquartile space or proportions regarding continuous gaussian, non-gaussian and categorical variables. Comparison between randomized groups will be done by using non paired Student t-test or Wilcoxon rank sum test regarding continuous variables, and by Chi2 test or Fisher exact regarding categorical variables, according to what is appropriate.
This study aims to demonstrate the superiority of an informative message with positive content over pain perception during intravenous cannulation. Statistical power is set at 80% to prove a difference, with alpha threshold at 0.05. Mean pain intensity is estimated at 34 mm on a Visual Analog Scale (possible intensity from 0 to 100 mm), with an estimated standard deviation at 24 mm. To detect the smallest clinically significative decrease in pain intensity (13 mm) caused by the intervention, a sample of 110 patients, that is 55 patients per group, is needed. Taking missing data or post-randomization patient withdrawal (estimated at 10%) into account, 60 patients will be randomized per group. A minimum of 240 patients in total for the two phases (that is the four arms of the study) will be needed to be enrolled.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 251 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Other |
| Official Title: | Impact of Communication on Pain During Intravenous Cannulation in an Emergency Department: a Randomized Controlled Trial |
| Actual Study Start Date : | December 13, 2017 |
| Actual Primary Completion Date : | December 15, 2018 |
| Actual Study Completion Date : | December 15, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Intervention message (first phase)
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
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Other: Experimental: Intervention message (first phase)
Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a recorded message |
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Active Comparator: Control message (first phase)
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.
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Other: Placebo Comparator: Control message (first phase)
Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a recorded message |
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Intervention message (second phase)
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.
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Other: Experimental: Intervention message (second phase)
Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a care provider |
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Active Comparator: Control message (second phase)
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.
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Other: Placebo Comparator: Control message (second phase)
Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a care provider |
- Patients' self-evaluation of pain intensity and pain unpleasantness before the peripheral venous catheter's insertion (basal rates). [ Time Frame: Pain intensity and unpleasantness will be assessed immediately at the end of the procedure. ]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.
- Patients' self-evaluation of pain intensity and pain unpleasantness due to the insertion of a peripheral venous catheter. [ Time Frame: Pain intensity and unpleasantness due to the catheter's insertion will be assessed about two minutes after the peripheral venous catheter's insertion. ]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.
- Patients' self-evaluation of anxiety before the peripheral venous catheter's insertion (basal rate). [ Time Frame: Anxiety will be assessed about ten minutes before the peripheral venous catheter's insertion. ]Anxiety 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 anxiety at all / extremely anxious) 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.
- Patients' self-evaluation of anxiety after the peripheral venous catheter's insertion. [ Time Frame: Anxiety will be assessed about two minutes after the peripheral venous catheter's insertion. ]Anxiety 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 anxiety at all / extremely anxious) 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.
- Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety. [ Time Frame: Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety will be assessed about ten minutes after the insertion of the peripheral venous catheter. ]Patients' pain intensity, pain unpleasantness and anxiety, as evaluated by the caregivers, will be assessed using specifically created Visual Analogue Scales, similar to the patients' scales only in paper form. The caregivers will indicate their evaluation by tracing a line on the scale going from one extreme to the other (no pain / worst pain imaginable). The co-investigators will then measure the distance between no pain (i.e. 0) and the line traced by the caregiver in millimeters and report this numerical value in the CRF.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient aged 18 or more;
- Patient whose medical care requires a peripheral venous catheter;
- Insertion of the peripheral venous catheter on the upper limb.
Exclusion Criteria:
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502655
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois (CHUV) | |
| Lausanne, Vaud, Switzerland, 1011 | |
| Principal Investigator: | Olivier Hugli, PD-MER, MPH | Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland |
Documents provided by Olivier Hugli, University of Lausanne Hospitals:
Other Publications:
| Responsible Party: | Olivier Hugli, Head of the inpatient service, Emergency Department, University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT03502655 |
| Other Study ID Numbers: |
VVP01112017 |
| First Posted: | April 19, 2018 Key Record Dates |
| Last Update Posted: | July 7, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pain Peripheral intravenous catheter Peripheral catheterization Communication Emergency Department |
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Emergencies Acute Pain Disease Attributes |
Pathologic Processes Pain Neurologic Manifestations |