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Recruiting NCT07010003

Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery

No phase Interventional Elective Heart Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupressure.
Who it may be relevant to
Registry conditions: Elective Heart Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure Acupressure
    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.

Primary outcome measures

  • Anxiety [Time frame: Preoperative (Day 1)]
Secondary outcome measures (7)
  • Anxiety [Time frame: 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)]
  • Specific preoperative anxiety [Time frame: Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1)]
  • Quality of life [Time frame: Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average)]
  • Pain intensity [Time frame: Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital]
  • Depression [Time frame: baseline (Day 0, preoperative)]
  • Postoperative Nausea and Vomiting [Time frame: Postoperative (Day 2)]
  • Major Adverse Cardiac and Cerebrovascular Events [Time frame: Discharge from hospital (Day 10 on average)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • Robert Bosch Krankenhaus — Stuttgart

Identifiers

NCT: NCT07010003 · 643/2024BO1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗