The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA - Trial NCT06411054
Access comprehensive clinical trial information for NCT06411054 through Pure Global AI's free database. This phase not specified trial is sponsored by Chinese University of Hong Kong and is currently Not yet recruiting. The study focuses on Pain, Acute. Target enrollment is 108 participants.
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Study Focus
Sponsor & Location
Chinese University of Hong Kong
Timeline & Enrollment
N/A
Jun 01, 2024
Dec 31, 2026
Primary Outcome
VAS pain score
Summary
Objectives: To prospectively evaluate the potential of acu-TENS to reduce the pain
 experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) and
 evaluate its safety profile.
 
 Hypothesis to be tested: Does the use of acu-TENS reduce pain in women undergoing USG-MVA?
 
 Design and subjects: A prospective randomized control trial will be carried out at the
 Department of Obstetrics and Gynaecology of the Prince of Wales Hospital. Women undergoing
 USG-MVA for the treatment of early pregnancy loss before 12 weeks of gestation will be
 randomized to receive acu-TENS (intervention group) or sham acu-TENS (control group) for pain
 control during USG-MVA. We will recruit 54 participants in each of the two arms, so a total
 of 108 patients will be recruited.
 
 Study instruments: USG-MVA will be performed using a 60ml charged syringe (MedGyn Aspiration
 Kit) with a flexible curette attached to it. Transabdominal ultrasound during the MVA
 procedure will be performed using Mindray DC-80A Diagnostic Ultrasound System. Acu-TENS will
 be performed using MTR+ Myolito Multifunctional Stimulator (MTRP-00003).
 
 Main outcome measures: Primary outcome includes pain scores before, during and after USG-MVA.
 Secondary outcomes include (1) stress levels measured by heart rate, heart rate variability,
 blood pressure, State Trait Anxiety Inventory (STAI), and salivary cortisol; (2) anxiety
 level; (3) Surgeon's assessment on the patient co-operation score and patient intraoperative
 pain, (4) Client Satisfaction Questionnaire (CSQ8) and satisfaction score, and (5) any
 adverse events of acu-TENS.
 
 Data analysis: Data analysis will be performed using the Statistical Packages of Social
 Sciences for Windows (SPSS, Inc).
 
 Expected results: We expect that acu-TENS will result in at least a 35% reduction in pain
 experienced by women undergoing USG-MVA.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06411054
Device Trial