Elective Heart SurgeryNCT07010003
Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
A study testing Acupressure in people with Elective Heart Surgery, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Heart Surgery
- What is being tested?
- Acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Robert Bosch Krankenhaus
Stuttgart, 70376
Nora Göbel, Priv.-Doz. Dr. med., +49 711 8101 3650, nora.goebel@rbk.de
About this study
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.
Read more
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
- Being tested
- Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative (Day 1)
Secondary outcomes (7)
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.
Measured: 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
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
Measured: Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1)
Quality of life
EQ5D
Measured: Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average)
Pain intensity
Numerical Rating Scale Scores range between 0 and 10, higher scores indicate higher pain intensity
Measured: Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital
Depression
Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.
Measured: baseline (Day 0, preoperative)
Postoperative Nausea and Vomiting
PONV
Measured: Postoperative (Day 2)
Major Adverse Cardiac and Cerebrovascular Events
MACCE
Measured: Discharge from hospital (Day 10 on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start13 May 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Heart SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch-Krankenhaus Stuttgart
- Responsible party
- Sponsor
- Investigators
- Nora Göbel, Dr. med., Principal investigator, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010003
- Sponsor's protocol ID
- 643/2024BO1
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
- ClinicalTrials.gov ID
- NCT07010003
- Acronym / sponsor ID
- 643/2024BO1
- Conditions
- Elective Heart Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Robert Bosch-Krankenhaus Stuttgart
- Study start
- 13 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Standard preoperative care |
| NADA-Acupressure | Experimental | Procedure: AcupressureParticipants in the intervention arm of the study receive standardized ear acupressure treatment according to the NADA protocol before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureEar 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. | Procedure or surgery | NADA-Acupressure |
Primary outcome
Anxiety
Time frame: 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.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora Göbel, Dr. med. principal investigator
Robert Bosch Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Elective Heart Surgery, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Göbel, Priv.-Doz. Dr. med. (+49 711 8101 3650, nora.goebel@rbk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Preoperative (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.