Elective Heart Surgery
Conditions
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.
Interventions
PROCEDUREAcupressure
Ear acupressure following the NADA Protocol is carried out using special acupuncture patches that press a small bead onto defined points on the ear: Shen Men, kidney, lung, liver, and vegetative. NADA ear acupressure is a non-invasive and low-risk intervention. In addition, the protocol is carried out exclusively by NADA-certified doctors, medical assistants, or nursing staff.
Sponsors
Robert Bosch-Krankenhaus Stuttgart
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Preoperative (Day 1) | State-Trait Anxiety Inventory - state (STAI-s) The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific preoperative anxiety | Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1) | Amsterdam Preoperative Anxiety and Information Scale (APAIS) For the anxiety subscale, scores range between 4 and 20, higher scores reflect higher anxiety. For the need for information subscale, scores range between 2 and 10, higher scores reflect higher need for information |
| Quality of life | Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average) | EQ5D |
| Pain intensity | Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital | Numerical Rating Scale Scores range between 0 and 10, higher scores indicate higher pain intensity |
| Anxiety | 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) | State-Trait Anxiety Inventory - state (STAI-s) The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety. |
| Postoperative Nausea and Vomiting | Postoperative (Day 2) | PONV |
| Major Adverse Cardiac and Cerebrovascular Events | Discharge from hospital (Day 10 on average) | MACCE |
| Depression | baseline (Day 0, preoperative) | Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms. |
Countries
Germany
Contacts
Primary ContactNora Göbel, Priv.-Doz. Dr. med.
Outcome results
None listed