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

Medical University of Graz

Status: Not yet enrolling

Conditions: Oncology; Symptoms and Signs; Insomnia

Treatments: Procedure: Hypno-ear-acupuncture; Procedure: Sham Hypno-ear-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06532188

24-001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups

Verum

Experimental group

Description:

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

Treatment:

Procedure: Hypno-ear-acupuncture

Sham

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham Hypno-ear-acupuncture