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NCT Number: NCT06532188

Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients

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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Key information

Conditions

Oncology Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Induction of a trance
  • suggestions for calm and good sleep

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

Primary outcomes

  1. Richards-Campbell Sleep Questionnaire (RCSQ)

    Time frame: 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 outcomes

  1. Edmonton symptom assessment scale (ESAS)

    Time frame: 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

  2. Patient health questionnaire 9 (PHQ-9)

    Time frame: 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

  3. Use of additional medication

    Time frame: From baseline to end of study (total seven days)

    Use of sleep medication (benzodiazepines) and analgesics (opioids, non-opioids, nonsteroidal anti-inflammatory drugs (NSAIDs)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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