NCT02333747

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

January 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

January 2, 2015

Last Update Submit

February 21, 2016

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • the quality of recovery, as measured by a 40-item questionnaire

    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)

    24 hours after surgery

Secondary Outcomes (3)

  • the incidence of postoperative nausea and vomiting

    24 hours after surgery

  • postoperative pain intensity, as assessed using Visual Analogue Scale (VAS)

    24 hours after surgery

  • patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad.

    at 24 hours after surgery

Study Arms (2)

the TEAS group

EXPERIMENTAL

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

the sham group

SHAM COMPARATOR

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

Interventions

the Hans electronic acupuncture apparatusDEVICE

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).

the TEAS groupthe sham group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

  • Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015.

    PMID: 26550304RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yanqing Chen, MD

    Fujian Provincial Hospital, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 7, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 23, 2016

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)