Auricular AcupressureNCT06087380
Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery
A study testing auricular acupressure and standard ward care in people with Auricular Acupressure and Cervical Spine Surgery, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The primary objective of this study is to investigate the effectiveness of auricular acupressure in improving post-cervical spine surgery pain and heart rate variability in patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Auricular Acupressure, Cervical Spine Surgery
- What is being tested?
- auricular acupressure and standard ward care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are over 20 years old and have undergone cervical spine surgery.
- Those who have clear consciousness and can communicate in Mandarin or Taiwanese.
- Patients who have undergone cervical spine surgery and have no complications (such as wound infection or postoperative limb mobility impairment) disability).
- Those who are willing to cooperate with ear acupuncture and heart rate variability testing.
- Those who agree to participate in the research and sign the consent form.
- The skin of the auricle is intact and has no deformation, defects or allergies.-
Who cannot join
- Those who use self-controlled pain control (PCA) after surgery.
- Those diagnosed with mental illness or cognitive impairment.
- Those who are transferred to the intensive care unit after surgery.
- Those who use breathing aids.
- Those with major chronic diseases, such as cardiovascular disease or cancer.
- Those who develop delirium after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery
The primary objective of this study is to investigate the effectiveness of auricular acupressure in improving post-cervical spine surgery pain and heart rate variability in patients.
Read the detailed description
This study adopts a quasi-experimental research design, where a medical center in northern Taiwan served as the enrollment location. Both the experimental group and the control group received standard ward care. The experimental group commenced auricular acupressure intervention post-surgery. Questionnaire assessments and heart rate variability measurements were conducted in the experimental group on the first, second, third, and fourth days before discharge. The control group did not receive auricular acupressure and underwent only questionnaire assessments and heart rate variability testing. Measurement tools included the McGill Pain Questionnaire and the Heart Master wrist-worn physiological monitor.
- Conditions
- Auricular Acupressure, Cervical Spine Surgery
- Being tested
- auricular acupressure, standard ward care
- Keywords
- cervical spine surgery, post-operative pain, auricular acupressure, heart variability.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureProcedure or surgery
Auricular pressure The experimental group commenced auricular acupressure intervention post-surgery. Questionnaire assessments and heart rate variability measurements were conducted in the experimental group on the first, second, third, and fourth days before discharge.
standard ward careOther
standard ward care
| Study group | Role | What they receive |
|---|---|---|
| Arms and Interventions | Experimental | The experimental group A total of 32 patients to undergo auricular acupuncture interventional Receives: Procedure: auricular acupressure; Other: standard ward care |
| No Intervention: Control group: | Other | The control group total 30 patients No interventions implemented Receives: Other: standard ward care |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-form Questionnaire McGill Pain, SF-MPQ)
It mainly assesses the nature and intensity of pain. The scale is mainly divided into three parts. The first part is the pain level index, which includes 11 questions on the sensory level of pain experience and 4 questions on the emotional level of pain experience, a total of 15 questions. The higher the score, the greater the pain. The more serious it is; the second part is the current pain intensity, the higher the score, the more severe the pain; the third part is the visual analog scale (VAS), the higher the score, the more severe the pain.
Measured: post op 1-4 day
Secondary outcomes (1)
Heart Rhythm Master Wrist Physiological Monitor
Monitors spectrum values such as high frequency of heart rate variability, low frequency of heart rate variability, and power ratio of high and low frequency of heart rate variability.The standard values of its measurement parameters: high-frequency power parameter (HF) is 40-60%, low-frequency power parameter (LF) is 40-60%, and autonomic nervous system activity balance parameter (LF/HF) is 0.8-1.5 ms2.
Measured: post op 1-4 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular AcupressureStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Principal investigator, Liu-ying Yin, National Taipei University of Nursing and Health Sciences
- Investigators
- Ying Yin Liu, Master, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087380
- Sponsor's protocol ID
- 2021-09-008B
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 31 Oct 2023
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT06087380
- Acronym / sponsor ID
- 2021-09-008B
- Conditions
- Auricular Acupressure, Cervical Spine Surgery
- Keywords
- cervical spine surgery, post-operative pain, auricular acupressure, heart variability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Oct 2023 (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.
The primary objective of this study is to investigate the effectiveness of auricular acupressure in improving post-cervical spine surgery pain and heart rate variability in patients.
Detailed description
This study adopts a quasi-experimental research design, where a medical center in northern Taiwan served as the enrollment location. Both the experimental group and the control group received standard ward care. The experimental group commenced auricular acupressure intervention post-surgery. Questionnaire assessments and heart rate variability measurements were conducted in the experimental group on the first, second, third, and fourth days before discharge. The control group did not receive auricular acupressure and underwent only questionnaire assessments and heart rate variability testing. Measurement tools included the McGill Pain Questionnaire and the Heart Master wrist-worn physiological monitor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arms and Interventions | Experimental | Procedure: auricular acupressure, Other: standard ward careThe experimental group A total of 32 patients to undergo auricular acupuncture interventional |
| No Intervention: Control group: | Other | Other: standard ward careThe control group total 30 patients No interventions implemented |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are over 20 years old and have undergone cervical spine surgery.
- Those who have clear consciousness and can communicate in Mandarin or Taiwanese.
- Patients who have undergone cervical spine surgery and have no complications (such as wound infection or postoperative limb mobility impairment) disability).
- Those who are willing to cooperate with ear acupuncture and heart rate variability testing.
- Those who agree to participate in the research and sign the consent form.
Key exclusion criteria (6 listed)
- Those who use self-controlled pain control (PCA) after surgery.
- Those diagnosed with mental illness or cognitive impairment.
- Those who are transferred to the intensive care unit after surgery.
- Those who use breathing aids.
- Those with major chronic diseases, such as cardiovascular disease or cancer.
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 |
|---|---|---|
| auricular acupressureAuricular pressure The experimental group commenced auricular acupressure intervention post-surgery. Questionnaire assessments and heart rate variability measurements were conducted in the experimental group on the first, second, third, and fourth days before discharge. | Procedure or surgery | Arms and Interventions |
| standard ward carestandard ward care | Other | Arms and Interventions, No Intervention: Control group: |
Primary outcome
short-form Questionnaire McGill Pain, SF-MPQ)
Time frame: post op 1-4 day
It mainly assesses the nature and intensity of pain. The scale is mainly divided into three parts. The first part is the pain level index, which includes 11 questions on the sensory level of pain experience and 4 questions on the emotional level of pain experience, a total of 15 questions. The higher the score, the greater the pain. The more serious it is; the second part is the current pain intensity, the higher the score, the more severe the pain; the third part is the visual analog scale (VAS), the higher the score, the more severe the pain.
1 secondary outcome
Heart Rhythm Master Wrist Physiological Monitor
Time frame: post op 1-4 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- 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. This study is not recruiting at the moment.
Ying Yin Liu, Master principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure and standard ward care in people with Auricular Acupressure and Cervical Spine Surgery, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 31 Oct 2023. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-form Questionnaire McGill Pain, SF-MPQ) (time frame: post op 1-4 day). 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 31 Oct 2023.