Trial document




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  DRKS00009036

Trial Description

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Title

Music intervention and its consequences during Port Placement and Extraction on anxiety

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Trial Acronym

POLKA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The trial examines the impact of music during port (device for venouse admission of drugs e.g. chemotherapy) placement and extraction on the anxiety of patients. Patients are being randomized to either music or not. Before, during and after surgery stress and anxiety is assesed by questionnaires, salivary cortisol, skin resistence and mini-EEG.

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Brief Summary in Scientific Language

A prospective, controlled, blinded, randomized trial on the impact of music on anxiety during port placement and extraction. All patients with an indication for this surgery are screened. After obtaining informed consent patients are randomized to either music therapy or standard care without music. Before, during and after surgery anxiety and stress are monitored by salivary cortisol concentrations, EEG as BIS index, skin resistence by 2Ch measurement and standardized psychological tests (STAI).

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Organizational Data

  •   DRKS00009036
  •   2015/09/28
  •   [---]*
  •   yes
  •   Approved
  •   5209, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   U1111-1173-3156 
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Health Condition or Problem studied

  •   Z95.81 -  [generalization Z95.8: Presence of other cardiac and vascular implants and grafts]
  •   Placement and extraction of port catheter
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Interventions/Observational Groups

  •   Music by headphones from entrance of operating room , during procedure (port placement or extraction) until exit of operating room music. Patients can choose out of for genres (classic, jazz, meditation, lounge)
  •   Only headphones without music
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Impact of music on anxiety measured by salivary cortisol, STAI questionnaire, skin resistance by finger electrodes at the time of skin closure.

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Secondary Outcome

Impact of music on:
• Duration of surgery
• Complications assesed by clinical documentation
• Evaluation of stress by biophysical measures as continouse variable and at skin closure (vitalparameters)
• analgetics use assesed by chart review at patients dismissal
• patients contentment assesed at dismissal by questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/05
  •   65
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patients with planned placement or extraction of port catheter
• Sufficent command of German language to answer survey
• Written informed consent to study participation

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Exclusion Criteria

• Hearing impairment that has significant impact on music perception
• severe illnesses that prohibit study participation (inestigators discretion) or patients that have a significantly increased risk for complications
• patients in need of full anaesthesia
• patients with anxiety disorders or other severe psychiatric illnesses
• patients missing mental or physical capacity to complete surveys

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik
    • Mr.  Dr. med.  Philip  Hepp 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  Dr. med.  Philip  Hepp 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  Dr. med.  Philip  Hepp 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting ongoing
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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.