Trial document




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  DRKS00017411

Trial Description

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Title

Evaluation of aromatherapy in palliative care

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Trial Acronym

EVA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients on palliative care units often suffer from agitation. The aim is to investigate whether aroma care with lavender, lemon balm or placebo in these troubled patients can relieve agitation. A pilot study will be carried out at the interdisciplinary pain and palliative ward of the University Hospital Schleswig-Holstein, Campus Kiel. Patients, who gave their consent, will be included and will receive one of the interventions in case of restlessness. The expected results will shed light on whether aromatherapy relieves people's agitation at the end of life and whether it can be safely implemented in the daily routine of a palliative care unit.

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Brief Summary in Scientific Language

Background
Patients on palliative care units often suffer from restlessness and agitation. In the non-pharmacological measures, it is still unclear whether an aroma care with lavender or melissa can relieve agitation.
Purpose
Review of the hypothesis: In palliative patients, who are restless, an aroma treatment with balm or lavender compared to a placebo (almond oil) will be a calming.
Design
Prospective, cluster-randomized 3-arm pilot study at the interdisciplinary pain and palliative ward of the University Hospital Schleswig-Holstein, Campus Kiel.
Method
Included are patients who a) give their consent, b) have a sense of smelling, c) are in a single room. Excluded are patients who have a) no consent, b) allergies to the fragrances or essential oils, c) no smelling ability (tracheal cannula, runny nose, etc.), d) no life-limiting illness, or e) other (foreign language, no caregiver etc.). Cluster randomization is done weekly by assigning patients to either the melissa, lavender or placebo intervention. The intervention is performed when patients are agitated, as measured by the Richmond Agitation Sedation Scale (RASS) 1 to 2. The intervention consists of a swab soaked with 3 drops of lemon balm, lavender oil or almond oil, which is <1 meter for 30 minutes placed next to the patient. The primary outcome measure is the change in RASS recorded 5 minutes before and 15, 30, and 60 minutes after the intervention. Secondary outcome measures are determined by the Minimum Documenting System (MIDOS2), a self-constructed "Confidence" scale (0-10, 10 = maximum confidence) and vital signs (heart and respiratory rate, blood pressure) and the feasibility of the intervention (degree of recruitment, ratio of performed vs. indicated interventions, number of security events).
Expected results
The expected results will shed light on whether the non-pharmacological intervention of aroma care relieves agitation in people at the end of life and whether the intervention in the everyday life of a palliative care unit can be safely implemented.

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Organizational Data

  •   DRKS00017411
  •   2019/05/28
  •   [---]*
  •   yes
  •   Approved
  •   D 465/19, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R45.1 -  Restlessness and agitation
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Interventions/Observational Groups

  •   Lavender oil, from which 3 drops are applied to a swab <1 meter distance to the patient for 30 minutes
  •   Melissa oil, from which 3 drops are applied to a swab <1 meter distance to the patient for 30 minutes
  •   Almond oil as placebo, from which 3 drops are applied to a swab <1 meter distance to the patient for 30 minutes
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Placebo
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Change in the Richmond Agitation Sedation Scale, assessed 5 minutes before and 15, 30, and 60 minutes after the intervention

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Secondary Outcome

Minimal documentation system (MIDOS2), a self-constructed scale "confidence" (0-10, 10 = maximum confidence) and vital signs (heart and respiratory rate, blood pressure), assessed 5 minutes before and 60 minutes after the intervention. Other parameters are the feasibility of the intervention (degree of recruitment, ratio of performed vs. indicated interventions, Number of safety events), assessed during the study period.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/09
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a) give their consent,
b) have a sense of smelling,
c) are in a single room.

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Exclusion Criteria

a) no consent,
b) allergies to the fragrances or essential oils,
c) no smelling ability (tracheal cannula, runny nose, etc.),
d) no life-limiting illness, or
e) other (foreign language, no caregiver etc.).

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Addresses

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    • Interdisziplinäre Schmerz- und Palliativstation Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Kai  Rossen 
    • Arnold-Heller-Str 3, Haus 12
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
    • Mr.  Peter  Nydahl 
    • Brunswiker Str. 10
    • 24105  Kiel
    • Germany
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    • Interdisziplinäre Schmerz- und Palliativstation Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Kai  Rossen 
    • Arnold-Heller-Str 3, Haus 12
    • 24105  Kiel
    • Germany
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    • Interdisziplinäre Schmerz- und Palliativstation Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Kai  Rossen 
    • Arnold-Heller-Str 3, Haus 12
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäre Schmerz- und Palliativstation Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Kai  Rossen 
    • Arnold-Heller-Str 3, Haus 12
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.