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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | 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 |
|
| Sham | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypno-ear-acupuncture | Procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Richards-Campbell Sleep Questionnaire (RCSQ) | Change in Patient-reported outcome measure assessing the sleep quality on five sleep related items using a visual analoge scale Range: 0-100mm (Visual Analog Scale) Domains/items: 5 (Sleep depth, Sleep latency, Awakenings from sleep, Ability to return to sleep, Sleep quality) Total score: mean score of all 5 domains (0-100) Interpretation: higher scores reflect better sleep quality | Baseline and after seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Edmonton symptom assessment scale (ESAS) | Change in Patient-reported outcome measures assessing nine different symptoms on a numerical rating scale Range: 0-10 (Numerical Rating Scale) Domains/items: 9 (pain, fatigue, drowsiness, nausea, annorexia, breathlesness, depression, anxiety, well-being) Total score: mean score of all 9 domains (range: 0-10) Interpretation: higher scores reflect higher symptom burden |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27451854 | Background | 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. | |
| 30477846 | Background | 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. |
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IPD may be made available on reasonable request
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Sham Hypno-ear-acupuncture | Procedure | 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 |
|
| Baseline and after seven days |
| Patient health questionnaire 9 (PHQ-9) | Change in Patient-reported outcome measure assessing depressive symptoms using 9 items describing the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria of depression. Range: 0-3 (categorial rating: 0 = "not at all", 3 = "nearly every day" Domains/items: 9 (interest/pleasure in doing things, feeling down or depressed, sleep-related problems, low energy or fatigue, eating problems, self-worth, ability to concentrate, psychomotor problems, thoughts of suicide) Total score: sum of all items (range: 0-27) Interpretation: higher scores reflect higher depressive symptoms | Baseline and after seven days |
| Use of additional medication | Use of sleep medication (benzodiazepines) and analgesics (opioids, non-opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) | From baseline to end of study (total seven days) |
| D001523 |
| Mental Disorders |
| D013568 | Pathological Conditions, Signs and Symptoms |