Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypno-ear-acupuncture, Sham Hypno-ear-acupuncture.
- Who it may be relevant to
- Registry conditions: Oncology, Insomnia, Symptoms and Signs. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients: a Randomized Clinical Trial
Overview
This randomized controlled trial aims to test if a combination of medical hypnosis and ear acupuncture improves sleep quality in patients with advanced cancer during a hospital stay in a palliative care unit. 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.
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- Richards-Campbell Sleep Questionnaire (RCSQ) [Time frame: Baseline and after seven days]
Secondary outcome measures (3)
- Edmonton symptom assessment scale (ESAS) [Time frame: Baseline and after seven days]
- Patient health questionnaire 9 (PHQ-9) [Time frame: Baseline and after seven days]
- Use of additional medication [Time frame: From baseline to end of study (total seven days)]
Eligibility criteria
Inclusion criteria
- histologically confirmed cancer
- RCSQ total score <25mm
- ability to read and understand the questionnaires
- ability to give informed consent
Exclusion criteria
- pregnancy
- language barrier (non German)
- inability to give informed consent
- hypacusis
- radiographical verified brain metastases
- diagnosed psychosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Graz — Graz
Publications
- 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. PMID 27451854
- 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. PMID 30477846
Identifiers
NCT: NCT06532188 · 24-001