NCT06087380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 12, 2023

Last Update Submit

October 29, 2023

Conditions

Auricular AcupressureCervical Spine Surgery

Keywords

cervical spine surgerypost-operative painauricular acupressureheart variability.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Heart Rhythm Master Wrist Physiological Monitor

    post op 1-4 day

Study Arms (2)

Arms and Interventions

EXPERIMENTAL

The experimental group A total of 32 patients to undergo auricular acupuncture interventional

Procedure: auricular acupressureOther: standard ward care

No Intervention: Control group:

OTHER

The control group total 30 patients No interventions implemented

Other: standard ward care

Interventions

auricular acupressurePROCEDURE

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.

Arms and Interventions
standard ward careOTHER

standard ward care

Arms and InterventionsNo Intervention: Control group:

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.-

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veterans general hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ying Yin Liu, Master

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taipei University of Nursing and Health Sciences

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 17, 2023

Study Start

February 15, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)