Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery

NCT ID: NCT07010003

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2026-05-31

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.

Conditions

Elective Heart Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment as usual

Standard preoperative care

Group Type: NO_INTERVENTION

No interventions assigned to this group

NADA-Acupressure

Participants in the intervention arm of the study receive standardized ear acupressure treatment according to the NADA protocol before surgery.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Bosch-Krankenhaus Stuttgart

UNKNOWN

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora Göbel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Robert Bosch Medical Center

Locations

Robert Bosch Krankenhaus

Stuttgart, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nora Göbel, Priv.-Doz. Dr. med.

Role: CONTACT

nora.goebel@rbk.de

+49 711 8101 3650

Facility Contacts

Nora Göbel, Priv.-Doz. Dr. med.

Role: primary

nora.goebel@rbk.de

+49 711 8101 3650

Other Identifiers

643/2024BO1

Identifier Type: -

Identifier Source: org_study_id