Postoperative ComplicationsNCT02333747
Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?
A study testing the Hans electronic acupuncture apparatus in people with Postoperative Complications, run by Fujian Provincial Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- the Hans electronic acupuncture apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery
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.
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- the Hans electronic acupuncture apparatus
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: the Hans electronic acupuncture apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours after surgery
Secondary outcomes (3)
the incidence of postoperative nausea and vomiting
Measured: 24 hours after surgery
postoperative pain intensity, as assessed using Visual Analogue Scale (VAS)
Measured: 24 hours after surgery
patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad.
Measured: at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Yanqing Chen, MD, Study director, Fujian Provincial Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333747
- Sponsor's protocol ID
- K2014-12-003
- Status last verified
- Jul 2015
- First submitted
- 2 Jan 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26550304
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery
- ClinicalTrials.gov ID
- NCT02333747
- Acronym / sponsor ID
- K2014-12-003
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the TEAS group | Experimental | Device: the Hans electronic acupuncture apparatusPatients 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). |
| the sham group | Sham comparator | Device: the Hans electronic acupuncture apparatusIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Hans electronic acupuncture apparatusTEAS 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). | Device | the TEAS group, the sham group |
Primary outcome
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)
3 secondary outcomes
the incidence of postoperative nausea and vomiting
Time frame: 24 hours after surgery
postoperative pain intensity, as assessed using Visual Analogue Scale (VAS)
Time frame: 24 hours after surgery
patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad.
Time frame: at 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Results publication: PubMed 26550304Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Chen, MD study director
Fujian Provincial Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Hans electronic acupuncture apparatus in people with Postoperative Complications, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the quality of recovery, as measured by a 40-item questionnaire (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.