Pain, AcuteDOUCIPNCT03502655
Discomfort During Intravenous Cannulation in an Emergency Department: Impact of Communication
A study testing Experimental: Intervention message (first phase) and Experimental: Intervention message (second phase) in people with Pain, Acute and Catheterization, Peripheral, run by Olivier Hugli at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Catheterization, Peripheral
- What is being tested?
- Experimental: Intervention message (first phase) and Experimental: Intervention message (second phase)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Dec 2017to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 or more;
- Patient whose medical care requires a peripheral venous catheter;
- Insertion of the peripheral venous catheter on the upper limb.
Who cannot join
- 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;
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Impact of Communication on Pain During Intravenous Cannulation in an Emergency Department: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Pain, Acute, Catheterization, Peripheral
- Being tested
- Experimental: Intervention message (first phase), Placebo Comparator: Control message (first phase), Experimental: Intervention message (second phase), Placebo Comparator: Control message (second phase)
- Keywords
- Pain, Peripheral intravenous catheter, Peripheral catheterization, Communication, Emergency Department
- Medical subject headings
- Acute Pain, Pain, Communication, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention message (first phase)Other
Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a recorded message
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
Experimental: Intervention message (second phase)Other
Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a care provider
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo Comparator: Control message (second phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: Anxiety will be assessed about two minutes after the peripheral venous catheter's insertion.
Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety.
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.
Measured: Caregivers' evaluation of patients' pain intensity, pain unpleasantness and anxiety will be assessed about ten minutes after the insertion of the peripheral venous catheter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start13 Dec 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier Hugli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Olivier Hugli, University of Lausanne Hospitals
- Investigators
- Olivier Hugli, PD-MER, MPH, Principal investigator, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502655
- Sponsor's protocol ID
- VVP01112017
- Acronym
- DOUCIP
- Status last verified
- Jul 2020
- First submitted
- 27 Nov 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
PubMed 18390493Krauss BS. "This may hurt": predictions in procedural disclosure may do harm. BMJ. 2015 Feb 6;350:h649. doi: 10.1136/bmj.h649.
PubMed 25663166Lang EV, Tan G, Amihai I, Jensen MP. Analyzing acute procedural pain in clinical trials. Pain. 2014 Jul;155(7):1365-1373. doi: 10.1016/j.pain.2014.04.013. Epub 2014 Apr 13.
PubMed 24731852Li SF, Greenwald PW, Gennis P, Bijur PE, Gallagher EJ. Effect of age on acute pain perception of a standardized stimulus in the emergency department. Ann Emerg Med. 2001 Dec;38(6):644-7. doi: 10.1067/mem.2001.119849.
PubMed 11719743Nevin K. Influence of sex on pain assessment and management. Ann Emerg Med. 1996 Apr;27(4):424-6. doi: 10.1016/s0196-0644(96)70222-6. No abstract available.
PubMed 8604851Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15.
PubMed 22424915Rat P, Jouve E, Pickering G, Donnarel L, Nguyen L, Michel M, Capriz-Ribiere F, Lefebvre-Chapiro S, Gauquelin F, Bonin-Guillaume S. Validation of an acute pain-behavior scale for older persons with inability to communicate verbally: Algoplus. Eur J Pain. 2011 Feb;15(2):198.e1-198.e10. doi: 10.1016/j.ejpain.2010.06.012. Epub 2010 Jul 17.
PubMed 20638878Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
PubMed 10339680Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth. 2012;12(3):22-9. doi: 10.1080/15265161.2011.652798.
PubMed 22416745Dutt-Gupta J, Bown T, Cyna AM. Effect of communication on pain during intravenous cannulation: a randomized controlled trial. Br J Anaesth. 2007 Dec;99(6):871-5. doi: 10.1093/bja/aem308. Epub 2007 Oct 30.
PubMed 17977860Greville-Harris M, Dieppe P. Bad is more powerful than good: the nocebo response in medical consultations. Am J Med. 2015 Feb;128(2):126-9. doi: 10.1016/j.amjmed.2014.08.031. Epub 2014 Sep 16.
PubMed 25232716Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
PubMed 10801169Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
PubMed 15733657Mistiaen P, van Osch M, van Vliet L, Howick J, Bishop FL, Di Blasi Z, Bensing J, van Dulmen S. The effect of patient-practitioner communication on pain: a systematic review. Eur J Pain. 2016 May;20(5):675-88. doi: 10.1002/ejp.797. Epub 2015 Oct 22.
PubMed 26492629Varelmann D, Pancaro C, Cappiello EC, Camann WR. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010 Mar 1;110(3):868-70. doi: 10.1213/ANE.0b013e3181cc5727. Epub 2009 Dec 30.
PubMed 20042440
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Communication on Pain During Intravenous Cannulation in an Emergency Department: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03502655
- Acronym / sponsor ID
- DOUCIP / VVP01112017
- Conditions
- Pain, Acute, Catheterization, Peripheral
- Keywords
- Pain, Peripheral intravenous catheter, Peripheral catheterization, Communication, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Olivier HugliUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention message (first phase) | Other | Other: Experimental: 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 |
| Control message (first phase) | Active comparator | Other: Placebo 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. |
| Intervention message (second phase) | Other | Other: Experimental: 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. |
| Control message (second phase) | Active comparator | Other: Placebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 or more;
- Patient whose medical care requires a peripheral venous catheter;
- Insertion of the peripheral venous catheter on the upper limb.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention message (first phase)Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a recorded message | Other | Intervention message (first phase) |
| Placebo Comparator: Control message (first phase)Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a recorded message | Other | Control message (first phase) |
| Experimental: Intervention message (second phase)Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a care provider | Other | Intervention message (second phase) |
| Placebo Comparator: Control message (second phase)Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a care provider | Other | Control message (second phase) |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 18390493Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
- Background: PubMed 25663166Krauss BS. "This may hurt": predictions in procedural disclosure may do harm. BMJ. 2015 Feb 6;350:h649. doi: 10.1136/bmj.h649.
- Background: PubMed 24731852Lang EV, Tan G, Amihai I, Jensen MP. Analyzing acute procedural pain in clinical trials. Pain. 2014 Jul;155(7):1365-1373. doi: 10.1016/j.pain.2014.04.013. Epub 2014 Apr 13.
- Background: PubMed 11719743Li SF, Greenwald PW, Gennis P, Bijur PE, Gallagher EJ. Effect of age on acute pain perception of a standardized stimulus in the emergency department. Ann Emerg Med. 2001 Dec;38(6):644-7. doi: 10.1067/mem.2001.119849.
- Background: PubMed 8604851Nevin K. Influence of sex on pain assessment and management. Ann Emerg Med. 1996 Apr;27(4):424-6. doi: 10.1016/s0196-0644(96)70222-6. No abstract available.
- Background: PubMed 22424915Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15.
- Background: PubMed 20638878Rat P, Jouve E, Pickering G, Donnarel L, Nguyen L, Michel M, Capriz-Ribiere F, Lefebvre-Chapiro S, Gauquelin F, Bonin-Guillaume S. Validation of an acute pain-behavior scale for older persons with inability to communicate verbally: Algoplus. Eur J Pain. 2011 Feb;15(2):198.e1-198.e10. doi: 10.1016/j.ejpain.2010.06.012. Epub 2010 Jul 17.
- Background: PubMed 10339680Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
- Background: PubMed 22416745Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth. 2012;12(3):22-9. doi: 10.1080/15265161.2011.652798.
- Results publication: PubMed 17977860Dutt-Gupta J, Bown T, Cyna AM. Effect of communication on pain during intravenous cannulation: a randomized controlled trial. Br J Anaesth. 2007 Dec;99(6):871-5. doi: 10.1093/bja/aem308. Epub 2007 Oct 30.
- Results publication: PubMed 25232716Greville-Harris M, Dieppe P. Bad is more powerful than good: the nocebo response in medical consultations. Am J Med. 2015 Feb;128(2):126-9. doi: 10.1016/j.amjmed.2014.08.031. Epub 2014 Sep 16.
- Results publication: PubMed 10801169Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Hugli, PD-MER, MPH principal investigator
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention message (first phase) and Experimental: Intervention message (second phase) in people with Pain, Acute and Catheterization, Peripheral, run by Olivier Hugli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502655, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.