Back to results

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

Primary Purpose

Postoperative Complications

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

the Hans electronic acupuncture apparatus

Sponsored by

Fujian Provincial Hospital

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Fujian Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

the TEAS group

the sham group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

the incidence of postoperative nausea and vomiting

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

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

Full Information

NCT ID

First Posted

January 2, 2015

Last Updated

February 21, 2016

Sponsor

Fujian Provincial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02333747

Brief Title

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

Official Title

The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fujian Provincial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

the TEAS group

Arm Type

Experimental

Arm Description

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).

Arm Title

the sham group

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

the Hans electronic acupuncture apparatus

Intervention Description

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 Measure Information:

Title

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

Description

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)

Time Frame

24 hours after surgery

Secondary Outcome Measure Information:

Title

the incidence of postoperative nausea and vomiting

Time Frame

24 hours after surgery

Title

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

Time Frame

24 hours after surgery

Title

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

Time Frame

at 24 hours after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqing Chen, MD

Organizational Affiliation

Fujian Provincial Hospital, China

Official's Role

Study Director

Facility Information:

Facility Name

Fujian Provincial Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350001

Country

China

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

26550304

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs