Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically confirmed cancer
RCSQ total score <25mm
ability to read and understand the questionnaires
ability to give informed consent
Disqualifiers
pregnancy
language barrier (non German)
inability to give informed consent
hypacusis
Trial design
Design model
Parallel
Treatments tested in this trial
Hypno-ear-acupuncture
Procedure/Surgery5 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
Procedure/Surgery5 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: VerumExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and after seven daysSecondary outcomes
1
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
Time frame
Baseline and after seven days2
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
Time frame
Baseline and after seven days3
Use of additional medication
Use of sleep medication (benzodiazepines) and analgesics (opioids, non-opioids, nonsteroidal anti-inflammatory drugs (NSAIDs)
Time frame
From baseline to end of study (total seven days)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: