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Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care (ADA-Pallia)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pain Anxiety Palliative Care | Other: Visual Analogic Scale |
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 Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes |
| Actual Study Start Date : | November 2, 2018 |
| Estimated Primary Completion Date : | November 4, 2020 |
| Estimated Study Completion Date : | November 4, 2020 |
- 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.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 6, 2019 | ||||||||
| First Posted Date | June 12, 2019 | ||||||||
| Last Update Posted Date | December 2, 2019 | ||||||||
| Actual Study Start Date | November 2, 2018 | ||||||||
| Estimated Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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 :
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care | ||||||||
| Official Title | Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients who have just been admitted in palliative care unit and who have communication abilities enough for pain and anxiety self-assessment. | ||||||||
| Condition |
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| Intervention | Other: Visual Analogic Scale
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.
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | November 4, 2020 | ||||||||
| Estimated Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Non-inclusion criteria :
Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03983590 | ||||||||
| Other Study ID Numbers | 35RC18_3054_ADA-PALLIA | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Rennes University Hospital | ||||||||
| Study Sponsor | Rennes University Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Rennes University Hospital | ||||||||
| Verification Date | November 2019 | ||||||||
