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.
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
- Conditions the study is for
- Effect of Positive Therapeutic Communication on Pain
- 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.
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 group | Role | What they receive |
|---|---|---|
| Positive Therapeutic communication | Experimental | Not described Receives: Biological: Arterial Blood Gas |
| Nocebo communication | Active comparator | Not described Receives: Biological: Arterial Blood Gas |
| Neutral communication | Active comparator | Not described Receives: Biological: Arterial Blood Gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted27 Jun 2022
- Study start1 Mar 2023
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Positive Therapeutic Communication on PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Le Terrier, Hôpital Fribourgeois
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05434169
- Acronym / sponsor ID
- POPAIN / 2022-00685
- Keywords
- Pain, Therapeutic communication, Hypnosis, Emergency department, Arterial blood gas, Blood sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 27 Jun 2022 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Therapeutic communication | Experimental | Biological: Arterial Blood Gas |
| Nocebo communication | Active comparator | Biological: Arterial Blood Gas |
| Neutral communication | Active comparator | Biological: Arterial Blood Gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Arterial Blood GasThe 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 | Biological | Neutral communication, Nocebo communication, Positive Therapeutic communication |
Primary outcome
Change of Pain
Time frame: Change of Pain at 3 minutes after the procedure from baseline
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)
4 secondary outcomes
Change of Comfort
Time frame: Change of Comfort at 3 minutes after the procedure from baseline
Change of Anxiety
Time frame: Change of Anxiety at 3 minutes after the procedure from baseline
Puncture failure
Time frame: at 3 minutes after the procedure
Global satisfaction with the communication strategy used
Time frame: at 3 minutes after the procedure
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 30 Aug 2024.
- Derived from this study: PubMed 37310776Schmutz 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.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.