PainADA-PalliaNCT03983590
Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care
An observational study of Pain and Anxiety, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care. The chosen event with a risk of pain and/or anxiety is the first bed bath after admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anxiety, Palliative Care
- What is being tested?
- Visual Analogic Scale
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2018to 27 Nov 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients who have just been admitted in palliative care unit and who have communication abilities enough for pain and anxiety self-assessment.
Who may be able to join
- admitted in palliative care
- -≥18 years old
- enough communication abilities to use VAS
- non opposition of the patient
- Non-inclusion criteria :
- previous bed bath already provided to the patient in the palliative unit (anxiolytic and analgesic strategies already adapted limiting the risk of pain or anxiety and the power of the study )
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- adult under legal protection (guardianship, trusteeship …)
- contraindication of ANI : respiratory rate < 10/min, non sinusal cardiac rythm, cardiotropic treatments
- behavioural disorders : agitation, confusion (Richmond scale score > ou = 1)
- alertness disorders : somnolence (Richmond scale score < ou = -1)
- no French speaking
Who cannot join
- providing the bad bath is impossible
- secondary opposition of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes
The main objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care.
The chosen event with a risk of pain and/or anxiety is the first bed bath after admission. The secondary objectives aim to identify ANI score thresholds which would be predictive of pain and/or anxiety and to figure out some individual factors influencing ANI scores.
Read the detailed description
Pain and anxiety assessments are still challenges for palliative care teams. Anxiolytics and painkillers are the usual tools but sometimes the symptoms and so the drugs to deliver are difficult to distinguish. For patients with maintained communication abilities, pain self-assessment using Visual Analogic Scores are the gold standard. Could pain assessment be optimised thanks to ANI? ANI is used in anaesthesiology and intensive care. The ANI system is based on the analysis of intra-cardiac variability. Based as an electrocardiograph with two electrodes on the patient's chest, it measures the balance between sympathetic/parasympathetic tones leading to a pain score. This score is predictive of pain occurrence, leading to an early analgesic treatment and a better control of pain with less quantity of drugs. However, some studies reported that anxiety and emotions could influence ANI pain score.
To test this hypothesis in palliative care field, this study compares pain and anxiety VAS to ANI scores before, during and after the bed bath.
- Conditions
- Pain, Anxiety, Palliative Care
- Being tested
- Visual Analogic Scale
- Keywords
- pain, anxiety, communicative, palliative care
- Medical subject headings
- Pain, Anxiety Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analogic ScaleOther
VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores at each measurement time.
ANI scores, pain VAS and anxiety VAS scores are the basic measures which will allow the needed calculations.
Significant results will be :
- the correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores
- the correlation rate of ANI scores and anxiety scores After a descriptive study of collected variables, the correlation rates between ANI scores and VAS scores will be calculated. Linear regression or mixt gamma will be used to assess the intra-individual variability (random effect). The effect of individual variables on the ANI scores will be tested (age, sex, diseases, medications) Considering 3 as the significant VAS threshold, ROC curves and Younden indice will be used to identify ANI scores leading to prediction of pain and/or anxiety.
Measured: VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start2 Nov 2018
- Primary completion25 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume ROBERT, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983590
- Sponsor's protocol ID
- 35RC18_3054_ADA-PALLIA
- Acronym
- ADA-Pallia
- Status last verified
- Apr 2022
- First submitted
- 6 Jun 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes
- ClinicalTrials.gov ID
- NCT03983590
- Acronym / sponsor ID
- ADA-Pallia / 35RC18_3054_ADA-PALLIA
- Conditions
- Pain, Anxiety, Palliative Care
- Keywords
- pain, anxiety, communicative, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 12 Jun 2019 (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 objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care.
The chosen event with a risk of pain and/or anxiety is the first bed bath after admission. The secondary objectives aim to identify ANI score thresholds which would be predictive of pain and/or anxiety and to figure out some individual factors influencing ANI scores.
Detailed description
Pain and anxiety assessments are still challenges for palliative care teams. Anxiolytics and painkillers are the usual tools but sometimes the symptoms and so the drugs to deliver are difficult to distinguish. For patients with maintained communication abilities, pain self-assessment using Visual Analogic Scores are the gold standard. Could pain assessment be optimised thanks to ANI? ANI is used in anaesthesiology and intensive care. The ANI system is based on the analysis of intra-cardiac variability. Based as an electrocardiograph with two electrodes on the patient's chest, it measures the balance between sympathetic/parasympathetic tones leading to a pain score. This score is predictive of pain occurrence, leading to an early analgesic treatment and a better control of pain with less quantity of drugs. However, some studies reported that anxiety and emotions could influence ANI pain score.
To test this hypothesis in palliative care field, this study compares pain and anxiety VAS to ANI scores before, during and after the bed bath.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have just been admitted in palliative care unit and who have communication abilities enough for pain and anxiety self-assessment.
Key inclusion criteria (11 listed)
- admitted in palliative care
- -≥18 years old
- enough communication abilities to use VAS
- non opposition of the patient
- previous bed bath already provided to the patient in the palliative unit (anxiolytic and analgesic strategies already adapted limiting the risk of pain or anxiety and the power of the study )
Key exclusion criteria (2 listed)
- providing the bad bath is impossible
- secondary opposition of the patient
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 |
|---|---|---|
| Visual Analogic ScaleVAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted. | Other | – |
Primary outcome
correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores at each measurement time.
Time frame: VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.
ANI scores, pain VAS and anxiety VAS scores are the basic measures which will allow the needed calculations. Significant results will be : * the correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores * the correlation rate of ANI scores and anxiety scores After a descriptive study of collected variables, the correlation rates between ANI scores and VAS scores will be calculated. Linear regression or mixt gamma will be used to assess the intra-individual variability (random effect). The effect of individual variables on the ANI scores will be tested (age, sex, diseases, medications) Considering 3 as the significant VAS threshold, ROC curves and Younden indice will be used to identify ANI scores leading to prediction of pain and/or anxiety.
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 5 Apr 2022.
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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.
Guillaume ROBERT, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Rennes University Hospital at 1 site in France.
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 11 inclusion and 2 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 5 Apr 2022. 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 France. 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?
correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores at each measurement time. (time frame: VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.