Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy
NCT ID: NCT03740984
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
81 participants
INTERVENTIONAL
2018-02-01
2021-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Hypnosis / Hypnotherapy
Hypnosis intervention has been created by a certified hypnosis therapist (Prof. Reinhard) has been audio-recorded. The hypnosis intervention is based on the patient's happy place as well as many other interventions which all focus on support and wellbeing (total recording time ca. 4 ½ hours). All patients are advice to start with the beginning, however during the course of chemotherapy they are allowed to skip mp3 files, if they prefer to listen to a new intervention.
Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
Music therapy
For the music therapy the following music recordings have been used. All patients were allowed to skip tracks if they did not like to listen to that particular track.
Purple Waves - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Black Garden View - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Sunset Destination - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Crystal Tree - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Best nature sounds / Ocean Volume 2 - Best Relaxation Music - Deep Sleep Top 10 Serse: Aria "Ombra mai Fu" - Andreas Scholl, Akademie für Alte music Berlin - Händel Johann Sebastian Bach: Jesus Bleibet Meine Freude (Studio) - Eduard Stan - Piano Recital Mozart: Concerto pour violon no 4 en re majeur, KV (Köchel listing) 218 - Christian Ferras; Pietro Argento; Orchestra Scarlatti di Nap - La fete a Stradivarius
... etc.
Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
Standard therapy
In this standard therapy the patient listens to a short explanation that they were randomized into the control arm and that they are allowed to listen to silence (tracks with no music or intervention).
Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
Interventions
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Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
Eligibility Criteria
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Inclusion Criteria
* compliance of the patient to fill out questionnaires
* informed consent and signed forms
* histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm)
* One of following chemotherapy regime:
4x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -\> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21-\>12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-\> 12 carboplatin, paclitaxel
Exclusion Criteria
* psychosis
* not able to sign consent form
18 Years
ALL
No
Sponsors
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Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
UNKNOWN
Dr. Horst Schmidt Klinik GmbH
INDUSTRY
Responsible Party
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Prof. Dr. Joscha Reinhard
Principal investigator
Locations
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Klinik für Gynäkologie und gynäkologischen Onkologie
Wiesbaden, Hesse, Germany
Helios Berlin Buch
Berlin, , Germany
Helios Kliniken Schwerin GmbH
Schwerin, , Germany
Countries
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Other Identifiers
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Gyn F-Chem
Identifier Type: -
Identifier Source: org_study_id