Clinical trial NCT07010003: Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
Official title: Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elective Heart Surgery
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch-Krankenhaus Stuttgart
First posted: 2025-06-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acupuncture and acupressure, rooted in Traditional Chinese Medicine, are used to treat a variety of symptoms. One specific and easy-to-apply method is ear acupuncture/acupressure following the NADA protocol (developed by the National Acupuncture Detoxification Association in 1985 in New York). This technique has been used successfully in Germany since 1995. It is known for its balancing and stabilizing effects on both body and mind, helping to reduce symptoms such as anxiety and stress, and promoting relaxation and inner calm.

Open-heart surgery can be emotionally overwhelming for patients, often triggering intense existential fears. Preoperative anxiety may worsen physical and psychological symptoms and negatively affect surgery outcomes. Therefore, non-pharmacological interventions like acupuncture are gaining importance alongside medication.

Several studies have demonstrated the effectiveness of preoperative acupuncture in reducing pain, anxiety, and nausea across various surgeries. Randomized trials show significant anxiety reduction through both body and ear acupuncture. One study found that ear acupuncture can rapidly improve psychological well-being, with effects noticeable within five minutes. This suggests its potential use not only the day before surgery but also immediately beforehand.

In contrast, research on ear acupressure before heart surgery is limited. However, one study reported improvements in sleep quality and reduced anxiety. A recent review highlighted the positive effects of ear stimulation on stress, blood pressure, and heart rate, and even suggested that acupressure may be more effective than acupuncture.


Eligibility criteria: Inclusion Criteria:

* All adult patients who are capable of giving consent or willing to do so and who are undergoing elective heart surgery at the Robert Bosch Krankenhaus study center are included.

Exclusion Criteria:

* Under 18 years old
* Emergency or urgent surgery
* Patients who are incapable of giving consent or unwilling to do so
* Patients who have received acupuncture treatment (including NADA ear acupuncture or acupressure) in the last three months

Primary outcomes:
measure: Anxiety
timeFrame: Preoperative (Day 1)
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital, on average 10 days)
measure: Specific preoperative anxiety
timeFrame: Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1)
measure: Quality of life
timeFrame: Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average)
measure: Pain intensity
timeFrame: Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital
measure: Depression
timeFrame: baseline (Day 0, preoperative)
measure: Postoperative Nausea and Vomiting
timeFrame: Postoperative (Day 2)
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: Discharge from hospital (Day 10 on average)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
Study officials:
affiliation: Robert Bosch Medical Center
name: Nora Göbel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: