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

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.

Study Overview

• Status: Completed
• Conditions: Auricular Acupressure; Cervical Spine Surgery
• Intervention / Treatment: Procedure: auricular acupressure; Other: standard ward care

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Those who are over 20 years old and have undergone cervical spine surgery.
2. Those who have clear consciousness and can communicate in Mandarin or Taiwanese.
3. Patients who have undergone cervical spine surgery and have no complications (such as wound infection or postoperative limb mobility impairment) disability).
4. Those who are willing to cooperate with ear acupuncture and heart rate variability testing.
5. Those who agree to participate in the research and sign the consent form.
6. The skin of the auricle is intact and has no deformation, defects or allergies.-

Exclusion Criteria:

1. Those who use self-controlled pain control (PCA) after surgery.
2. Those diagnosed with mental illness or cognitive impairment.
3. Those who are transferred to the intensive care unit after surgery.
4. Those who use breathing aids.
5. Those with major chronic diseases, such as cardiovascular disease or cancer.
6. Those who develop delirium after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arms and Interventions; The experimental group A total of 32 patients to undergo auricular acupuncture interventional	Procedure: auricular acupressure; 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.; Other: standard ward care; standard ward care
Other: No Intervention: Control group: The control group total 30 patients No interventions implemented	Other: standard ward care; standard ward care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	post op 1-4 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	post op 1-4 day

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ying Yin Liu, Master, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: post-operative pain; auricular acupressure; cervical spine surgery; heart variability.
• Other Study ID Numbers: 2021-09-008B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No