Insomnia, Oncology, Symptoms and Signs
Conditions
Keywords
ear acupuncture, medical hypnosis
Brief summary
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
PROCEDUREHypno-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
PROCEDURESham 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
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Richards-Campbell Sleep Questionnaire (RCSQ) | Baseline and after seven days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edmonton symptom assessment scale (ESAS) | Baseline and after seven days | 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 |
| Patient health questionnaire 9 (PHQ-9) | Baseline and after seven days | 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 |
| Use of additional medication | From baseline to end of study (total seven days) | Use of sleep medication (benzodiazepines) and analgesics (opioids, non-opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) |
Countries
Austria
Outcome results
None listed