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

• Sponsor: National Taipei University of Nursing and Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT06087380
• Collaborator: Taipei Veterans General Hospital, Taiwan (Other)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Auricular Acupressure; Cervical Spine Surgery	Other: Arms and Interventions	N/A

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

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: The Effectiveness of Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery
• Actual Study Start Date: Feb 15, 2022
• Actual Primary Completion Date: Mar 31, 2023
• Actual Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arms and Interventions The experimental group A total of 32 patients to undergo auricular acupuncture interventional	Other: Arms and Interventions; 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.
No Intervention: No Intervention: Control group: The control group total 30 did not receive auricular acupressure and underwent only questionnaire assessments and heart rate variability testing

Outcome Measures

Primary Outcome Measures

1. The effect of interventional auricular point sticking on pain in patients after cervical spine surgery [post op 1-4 day]

   Statistically significant differences were achieved on the first day after surgery ( p = .007), the second day after surgery ( p = .006), the third day after surgery ( p = .003), and the fourth day after surgery ( p = .032). (p < .05)

Secondary Outcome Measures

1. Effect of interventional auricular point sticking on heart rate variability in patients after cervical spine surgery [post op 1-4 day]

   Statistically significant results were achieved on the first day after surgery ( p < .001), the second day after surgery ( p < .001), the third day after surgery p < .001), and the fourth day after surgery ( p < .001). Difference (p < .05)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei veterans general hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taipei University of Nursing and Health Sciences
• Taipei Veterans General Hospital, Taiwan

Investigators

• Principal Investigator: Ying Yin Liu, Master, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu-ying Yin, National Taipei University of Nursing and Health Sciences, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT06087380
• Other Study ID Numbers: 2021-09-008B
• First Posted: Oct 17, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liu-ying Yin, National Taipei University of Nursing and Health Sciences, National Taipei University of Nursing and Health Sciences: cervical spine surgery; post-operative pain; auricular acupressure; heart variability.

Study Results

No Results Posted as of Oct 17, 2023