Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
NCT ID: NCT06532188
Last Updated: 2024-08-21
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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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-10-01
2024-12-31
Brief Summary
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Patients submitted to our palliative care unit will receive a medical hypnosis and ear acupuncture on the second day of their stay. Sleep quality will be measured using validated patient-reported outcome measures at baseline and after 7 days. Additionally, the use of sleep medication will be documented as a secondary outcome.
The intervention will be compared to a sham medical hypnosis and ear acupuncture to see if the effect of the true intervention has a unique effect.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verum
Ear acupuncture using permanent needles on predefined acupuncture points followed by a standardized medical hypnosis, needles remain in place for a total of 7 days
Hypno-ear-acupuncture
5 acupuncture permanent needles on ear acupuncture points according to the National Acupuncture Detoxification Association (NADA) protocol, needle retention after 7 days standardized medical hypnosis:
* Induction of a trance
* suggestions for calm and good sleep
Sham
Ear acupuncture using permanent needles on predefined acupuncture sham points followed by a standardized story without induction of a hypnotic trance, needles remain in place for a total of 7 days
Sham Hypno-ear-acupuncture
5 acupuncture permanent needles on ear acupuncture points inserted at non-specific points on the backside of the outer ear, needle retention after 7 days standardized sham hypnosis
\- story without trance induction and suggestions
Interventions
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Hypno-ear-acupuncture
5 acupuncture permanent needles on ear acupuncture points according to the National Acupuncture Detoxification Association (NADA) protocol, needle retention after 7 days standardized medical hypnosis:
* Induction of a trance
* suggestions for calm and good sleep
Sham Hypno-ear-acupuncture
5 acupuncture permanent needles on ear acupuncture points inserted at non-specific points on the backside of the outer ear, needle retention after 7 days standardized sham hypnosis
\- story without trance induction and suggestions
Eligibility Criteria
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Inclusion Criteria
* RCSQ total score \<25mm
* ability to read and understand the questionnaires
* ability to give informed consent
Exclusion Criteria
* language barrier (non German)
* inability to give informed consent
* hypacusis
* radiographical verified brain metastases
* diagnosed psychosis
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of Graz
Graz, Styria, Austria
Countries
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References
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Ahlberg R, Skarberg K, Brus O, Kjellin L. Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Subst Abuse Treat Prev Policy. 2016 Jul 25;11(1):24. doi: 10.1186/s13011-016-0068-z.
Lam TH, Chung KF, Lee CT, Yeung WF, Yu BY. Hypnotherapy for insomnia: A randomized controlled trial comparing generic and disease-specific suggestions. Complement Ther Med. 2018 Dec;41:231-239. doi: 10.1016/j.ctim.2018.10.008. Epub 2018 Oct 9.
Other Identifiers
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24-001
Identifier Type: -
Identifier Source: org_study_id
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