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

Not Applicable

Completed

• Conditions: Cervical Spine Surgery; Auricular Acupressure
• Interventions: Other: standard ward care; Procedure: auricular acupressure

• Registration Number: NCT06087380
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

Brief 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.

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 Timeline

• Study Start: 2022-02-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-17
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.-

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intervention: Control group:	standard ward care	The control group total 30 patients No interventions implemented
Arms and Interventions	standard ward care	The experimental group A total of 32 patients to undergo auricular acupuncture interventional
Arms and Interventions	auricular acupressure	The experimental group A total of 32 patients to undergo auricular acupuncture interventional

Primary Outcome Measures

Name	Time	Method
short-form Questionnaire McGill Pain, SF-MPQ)	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 Outcome Measures

Name	Time	Method
Heart Rhythm Master Wrist Physiological Monitor	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.

Trial Locations

Locations (1)

Taipei veterans general hospital; 🇨🇳 Taipei, Taiwan