Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
- Conditions
- Symptoms and SignsInsomniaOncology
- Interventions
- Procedure: Hypno-ear-acupunctureProcedure: Sham Hypno-ear-acupuncture
- Registration Number
- NCT06532188
- Lead Sponsor
- Medical University of Graz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- histologically confirmed cancer
- RCSQ total score <25mm
- ability to read and understand the questionnaires
- ability to give informed consent
- pregnancy
- language barrier (non German)
- inability to give informed consent
- hypacusis
- radiographical verified brain metastases
- diagnosed psychosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum Hypno-ear-acupuncture 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 Hypno-ear-acupuncture 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Styria, Austria