Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery

NCT07010003 | Recruiting

• 1 other identifier: 643/2024BO1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Anxiety

  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.

  Preoperative (Day 1)

Secondary Outcomes (7)

• 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)

• Specific preoperative anxiety

  Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1)

• Quality of life

  Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average)

• Pain intensity

  Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital

• Depression

  baseline (Day 0, preoperative)

Study Arms (2)

Treatment as usual

NO INTERVENTION

Standard preoperative care

NADA-Acupressure

EXPERIMENTAL

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

Procedure: Acupressure

Interventions

Acupressure 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.

NADA-Acupressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Robert Bosch-Krankenhaus Stuttgart: collaborator

Study Sites (1)

Robert Bosch Krankenhaus

Stuttgart, 70376, Germany

RECRUITING

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nora Göbel, Dr. med.

  Robert Bosch Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Göbel, Priv.-Doz. Dr. med.

CONTACT

+49 711 8101 3650; nora.goebel@rbk.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 8, 2025
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)