Trial document




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  DRKS00015641

Trial Description

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Title

Individualized music for people with dementia – A Study of possible stress markers

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Since people with dementia, especially in an advanced stage of the disease, cannot adequately express themselves, evaluation of interventions is often performed by using observer ratings. These ratings may differ from the actual experience of the people with dementia. Therefore, additionally objective data should be used to measure the effectiveness of intervention programs for people with less capability to introspection. Specific to musical therapy the analyses of saliva with regard to possible stress markers as cortisol or alpha-amylase can be meaningful. Results obtained via this non-invasive and objective method can give insight into stress reduction achieved through listening to individualized music. Therefore, this method is going to implemented in already registered study (see DRKS-ID: DRKS00013793). The aim of the study is to investigate the effect of individualized music on people with dementia in regard of their overall stress levels as well as their stress response while listening to their music.
The participants will be randomly assigned to an intervention or a control group. Over a period of 6 weeks, participants of the intervention group will listen to their individualized music playlist every other day for 20 minutes. The control group participants will receive standard care. During this period, saliva collection will be conducted for both groups at the beginning and at the end of the intervention.

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Brief Summary in Scientific Language

First promising evidence has been provided for the effects of individualized music therapy for people with dementia (see DRKS00013793). However, specifically for stress reduction achieved by individualized music programs for people with dementia no studies have been found. Nevertheless, there is evidence for effects on cortisol and alpha-amylase for the general population. Thus, research aimed at effects of individualized music on people with dementia is needed.
The aim of the study is to investigate the effect of individualized music on people with dementia in regard of their overall stress levels as well as their stress response while listening to their music. The study uses a randomized controlled 3x2x2 design.
During the six weeks of intervention (see also DRKS00013793: the tests of this study are integrated in the study design of the projects with the above noted ID-number. Below, only relevant details for the present study will be presented), the intervention group participants listen to their individualized playlist through headphones every other day for 20 minutes. In this period of time, observation of behavior will be conducted for both groups every other week for 60 minutes. During the first and the last observation of behavior saliva samples will be collected using SalivaBio Children's Swabs (SCS, Salimetrics). To measure biological stress markers, we will collect three times saliva during each observation of behavior. First, directly before listening to the music (t1), then directly afterwards (t2) and finally at the end of the observation period (t3).

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Organizational Data

  •   DRKS00015641
  •   2018/09/21
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  •   yes
  •   Approved
  •   FSV18/39, Friedrich-Schiller-Universität Jena - Ethikkommission der Fakultät für Sozial- und Verhaltenswissenschaften - 07743 Jena
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Secondary IDs

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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week before, during and after the music intervention. During the first and the last observation of behavior saliva samples will be collected three times. First, directly before listening to the music, then directly afterwards and finally at the end of each observation period.

  •   The control group receives standard care. The saliva collection will be conducted with the same frequency and duration as in the intervention group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Stress (saliva analyses):
a) cortisol as a marker of the hypothalamus-pituitary-adrenal axis
b) alpha-amylase as a marker of the vegetative nervous system

saliva will be collected two times during the intervention period (6 weeks, Method: SalivaBio Children's Swab (SCS, Salimetrics)). At each timepoint before, after and 20min after listening to the music saliva will be collected. The same frequency will be uphold for the controll group.

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Secondary Outcome

Subjective stress ratings (smiley assessment scale) at each saliva collection timpe point to assess discrepancies between subjective and objective measures of stress.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2018/09/24
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

care-dependent people with dementia living in a nursing home

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Exclusion Criteria

oral administration of drugs containing cortisol, radiotherapy/chemotherapy in the past

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Addresses

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    • Friedrich-Schiller-Universität Jena
    • Humboldtstr. 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtstr. 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität
    • Ms.  M.Sc.  Mareike  Sittler 
    • Humboldtstr. 11
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • GKV Spitzenverband der Pflege- und Krankenkassen
    • 10117  Berlin
    • Germany
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    • Friedrich-Schiller-Universität Jena
    • Humboldtstr. 11
    • 07743  Jena
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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