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Effect of Positive Therapeutic Communication on PainPOPAINNCT05434169

Effect of Positive Therapeutic Communication on Pain

A study testing Arterial Blood Gas in people with Effect of Positive Therapeutic Communication on Pain, run by Hôpital Fribourgeois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain, defined as a disagreeable sensory or emotional experience, is the most frequent symptom among patients admitted to the emergency department (ED). It is estimated that this symptom can be observed in almost 80% of patients upon their arrival to the ED. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Arterial Blood Gas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
1 siteSwitzerland
Study dates
1 Mar 2023to 28 Aug 2024
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

  • Patients over 18 years of age.
  • Patients scheduled to undergo radial ABG collection during their visit to the ED to allow to pursue routine care.
  • Free and informed consent of the patient received orally from one of the study investigators at study entry.

Who cannot join

  • Vital emergency requiring immediate resuscitation
  • Patients incapable of judgement.
  • Patients with conditions that render them unable to participate in the intervention of the present study, e.g., cognitive impairment, major hearing loss without the use of hearing aids, acute psychiatric disorders, under intravenous or oral sedation.
  • Patients with an insufficient understanding of the French language as defined by self-evaluation.
  • Local anesthesia (subcutaneous, transdermal patch) at the point of ABG puncture.
  • Patients already treated with anxiolytics or sedatives during care at the ED.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Firbourg Hospital

    Fribourg, 1700

Other trials in Switzerland

About this study

Official title: Effect of POsitive Therapeutic Communication on PAIN and Anxiety During Arterial Blood Gas Standardized Procedures in the Emergency Department Compared With Traditional Communication: a Monocentric Randomized Controlled Trial

Pain, defined as a disagreeable sensory or emotional experience, is the most frequent symptom among patients admitted to the emergency department (ED). It is estimated that this symptom can be observed in almost 80% of patients upon their arrival to the ED. Despite several international recommendations concerning pain management, pain in the context of an emergency situation often remains underestimated. Medical procedures, such as venous or arterial blood collection, which are essential for diagnostic management and patient care, can also generate pain and a high level of stress for patients who are already weakened by their underlying condition. This is known as "care-related pain".

Arterial blood gas (ABG) sampling is necessary to assess the gravity of the patient's condition and is a procedure conducted routinely in the ED. In a medium-size hospital (30,000 hospitalizations per year), approximately 1000 ABG tests are conducted annually. However, ABG collection is generally associated with pain and patient anxiety.

Read more

In order to decrease the perception of pain linked to the collection of arterial blood, several methods have been studied, such as applying a topical anesthetic cream (lidocaine, xylocaine) or a subcutaneous infection of lidocaine prior to the procedure. Given that ABG collection is often performed in emergency situations and that the anesthetic cream must be applied at least one hour before sampling, this method is not adapted to emergency practices. In a previous study, a subcutaneous injection of lidocaine did not allow to significantly reduce pain during radial artery puncture. Similarly, another study using ultrasound guidance for ABG sampling did not show any significant decrease in pain, the rate of immediate complications, or physician satisfaction.

Apart from the therapeutic tools commonly used, communication is a key element of care. In routine practice, caregivers inform patients that they are going to perform a potentially painful act. However, forewarning a patient that one will perform a painful act increases the perception of pain. It has also been shown that a communication strategy including the use of positive, kind or reassuring terms ("let me reassure you…", "are you comfortable?", "are you warm enough?") can contribute to decreasing the pain, while conversely, the choice of terms with a negative connotation ("okay, this might sting", "don't panic", "are you in pain?", "are you cold?") may increase the perception of pain and provoke a sense of discomfort. In the latter case, this is known as the "nocebo" effect. A communication strategy including reassuring terms, perceived by the brain as an agreeable information, allows to decrease the penibility dimension or connotes otherwise the pain in order to make it more bearable, thus modulating the painful perception. The objective of this strategy is that the painful message becomes less present as much as possible and that the patient benefits from a feeling of control. This procedure is widely used in hypnosis communication and is based on a neurobiological rationale, i.e., an increase in the secretion of endogenous opioids affecting the pain modulation networks decreases transmission in the pain pathways, thus leading to a release of dopamine in the striatum. This technique has already shown to be of benefit in patient management in various domains, such as anesthesia and pediatrics.

Arrival at the ED can induce a particular state of consciousness linked to anxiety and a heightened suggestibility of negative communication. Although several studies have compared the impact of verbal attitudes, notably in the domain of anesthesia and mainly with staff already trained in hypnosis, to our knowledge, none has studied the effect of positive communication by caregivers or physicians among a patient population in the ED setting. Given the limited therapeutic options to relieve the pain and discomfort of blood collection performed in the ED, we would like to evaluate in this study the potential benefit of positive therapeutic communication on pain and anxiety among patients who require ABG compared to nocebo or neutral communication.

Being tested
Arterial Blood Gas
Keywords
Pain, Therapeutic communication, Hypnosis, Emergency department, Arterial blood gas, Blood sampling
Medical subject headings
Pain, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterial Blood GasBiological

    The procedure of arterial blood collection will be conducted in a seated position for all three groups. The patient is in a supine position, with the forearm comfortably placed on a small table. The needle used for blood collection is a 25 gauge needle without local anesthetic. This method of sampling is identical to the one used in daily practice in the Emergency department of Fribourg

Study groups in NCT05434169
Study groupRoleWhat they receive
Positive Therapeutic communicationExperimentalNot described
Receives: Biological: Arterial Blood Gas
Nocebo communicationActive comparatorNot described
Receives: Biological: Arterial Blood Gas
Neutral communicationActive comparatorNot described
Receives: Biological: Arterial Blood Gas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Pain

    Self-evaluation of maximum pain felt by the patient during collection of an ABG sample on a Verbal Rating Scale (VRS) (0 = no pain - 10 = worst imaginable pain)

    Measured: Change of Pain at 3 minutes after the procedure from baseline

Secondary outcomes (4)
  1. Change of Comfort

    Self-evaluation of patient comfort using a simple comfort VRS (0 = no comfort - 10 = most comfortable imaginable)

    Measured: Change of Comfort at 3 minutes after the procedure from baseline

  2. Change of Anxiety

    Self-evaluation of patient anxiety using a simple anxiety VRS (0 = no anxiety - 10 = the worst anxiety imaginable)

    Measured: Change of Anxiety at 3 minutes after the procedure from baseline

  3. Puncture failure

    The success of the first arterial puncture will be assessed by the accredited evaluator at the end of the procedure by the number of puncture points visible on the patient's skin. Possible response: one puncture visible, yes/no.

    Measured: at 3 minutes after the procedure

  4. Global satisfaction with the communication strategy used

    Evaluation by the patient at the end of the procedure using a numeric scale of 0 to 10 (0 = extremely dissatisfied - 10 = extremely satisfied).

    Measured: at 3 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start1 Mar 2023
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434169
Sponsor's protocol ID
2022-00685
Acronym
POPAIN
Status last verified
Aug 2024
First submitted
13 Jun 2022
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Schmutz T, Le Terrier C, Ribordy V, Iglesias K, Guechi Y. The Effect of Positive Therapeutic Communication on Pain (POPAIN) and Anxiety During Arterial Blood Gas Standardized Procedures in the Emergency Department Compared to Traditional Communication: Protocol for a Monocentric Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 13;12:e42043. doi: 10.2196/42043.

    PubMed 37310776

Questions about this trial

What is this clinical trial studying?

A study testing Arterial Blood Gas in people with Effect of Positive Therapeutic Communication on Pain, run by Hôpital Fribourgeois 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 6 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 30 Aug 2024. 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?

Change of Pain (time frame: Change of Pain at 3 minutes after the procedure from baseline). 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 NCT05434169, which also lists 1 linked publication.

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 30 Aug 2024.

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