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Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?

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ClinicalTrials.gov Identifier: NCT02333747
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital

Brief Summary:
The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators conducted this prospective, randomized, double-blind study to verify the hypothesis that pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.

Condition or disease Intervention/treatment Phase
Postoperative Complications Device: the Hans electronic acupuncture apparatus Not Applicable

Detailed Description:
Transcutaneous electric acupoint stimulation (TEAS) is a form of non-invasive electrical stimulation that produces a perceptible sensation via electrodes attached to the skin. It has no risk of infections and can potentially be applied by medical personnel with minimal training. Clinical trials have demonstrated that TEAS reduces the consumption of intra-operative anesthetics and general anesthesia related side-effects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: the TEAS group
Patients in the TEAS group received pre-operative TEAS for 30 min before the induction of anesthesia using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China) in the holding area. TEAS was applied to two pairs of acupoints: bilateral Hegu (LI4) and Neiguan (PC6).
Device: the Hans electronic acupuncture apparatus
TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).

Sham Comparator: the sham group
In the sham group, the patients were connected to the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China), but electronic stimulation was not applied.
Device: the Hans electronic acupuncture apparatus
TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).




Primary Outcome Measures :
  1. the quality of recovery, as measured by a 40-item questionnaire [ Time Frame: 24 hours after surgery ]
    The primary outcome was the quality of recovery, which was assessed on the day before surgery and 24 h after surgery using a 40-item questionnaire (QoR-40)


Secondary Outcome Measures :
  1. the incidence of postoperative nausea and vomiting [ Time Frame: 24 hours after surgery ]
  2. postoperative pain intensity, as assessed using Visual Analogue Scale (VAS) [ Time Frame: 24 hours after surgery ]
  3. patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad. [ Time Frame: at 24 hours after surgery ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive female patients aged 18 to 60 with American Society of Anesthesiologists physical status (ASA) physical status I or II, who underwent general anesthesia for elective thyroidectomy surgery

Exclusion Criteria:

  • potentially difficult airway,
  • a history of chronic pain,
  • drug or alcohol abuse,
  • mental disorder,
  • intake of any analgesic drug within 48 h before surgery, and
  • previous experience with acupuncture treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333747


Locations
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Fujian Provincial Hospital
Investigators
Study Director: Yanqing Chen, MD Fujian Provincial Hospital, China

Publications of Results:
Responsible Party: Yao Yusheng, Professor, Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT02333747     History of Changes
Other Study ID Numbers: K2014-12-003
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes