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NCT Number: NCT06087380

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei veterans general hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.-

Exclusion criteria

  • 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.

Treatment and study plan

Auricular acupressure

Procedure

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 care

Other

standard ward care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Heart Rhythm Master Wrist Physiological Monitor

    Time frame: post op 1-4 day

    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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

The Effectiveness of Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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