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Trial Title:
Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
NCT ID:
NCT06532188
Condition:
Oncology
Insomnia
Symptoms and Signs
Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Conditions: Keywords:
ear acupuncture
medical hypnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Hypno-ear-acupuncture
Description:
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
Arm group label:
Verum
Intervention type:
Procedure
Intervention name:
Sham Hypno-ear-acupuncture
Description:
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
Arm group label:
Sham
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University of Graz
Address:
City:
Graz
Zip:
8036
Country:
Austria
Start date:
October 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Medical University of Graz
Agency class:
Other
Source:
Medical University of Graz
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532188
