ACU-TENS on Pain and Stress Reduction Before and During TUGOR
NCT ID: NCT06910540
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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Hypothesis to be tested: Does the use of acu-TENS reduce 50% of pain in TUGOR? Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology, Prince of Wales Hospital. 144 women undergoing TUGOR will be randomized to receive acu-TENS or sham acu-TENS for pain control during TUGOR.
Study instruments: During the TUGOR procedure, ultrasound of the pelvis will be performed by Aloka ProSound SSD-3500SX device (Japan). Each follicle will be pierced using a single lumen ovum aspiration needle or a double lumen ovum aspiration catheter (COOK Medical, UK) under ultrasound guidance. Acu-TENS will be done using MTR+ Myolito Multifunctional Stimulator.
Main outcome measures: Primary outcome is the pain score before and during TUGOR. Secondary outcomes include (1) other pain level parameters including pain control satisfaction, surgeon's assessment of the patient co-operation score and patient intraoperative pain; (2) stress and anxiety levels, Stait Trait Anxiety Inventory, General Health Questionnaire, Beck Depression Inventory, and saliva cortisol; (3) patient's satisfaction measured by Client Satisfaction Questionnaire and satisfaction score on pain control; (4) difficulty in retrieving oocytes; (5) IVF parameters; (6) safety profile; and (7) bias assessment.
Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows.
Expected results: The investigators expect that acu-TENS will reduce 50% of pain in TUGOR.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acu-TENS
Acu-TENS treatment
Acu-TENS
This protocol makes use of the acu-TENS treatment on the acupoints Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LR3). After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTR+ Myolito Multifunctional Stimulator MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 3-5 mA, and pulse width of 300µS will be delivered continually during TUGOR.
Sham acu-TENS
Sham acu-TENS without electric current
Sham acu-TENS
In the sham acu-TENS, within the same time interval, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.
Interventions
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Acu-TENS
This protocol makes use of the acu-TENS treatment on the acupoints Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LR3). After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTR+ Myolito Multifunctional Stimulator MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 3-5 mA, and pulse width of 300µS will be delivered continually during TUGOR.
Sham acu-TENS
In the sham acu-TENS, within the same time interval, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient with severe cardiac and respiratory disease history
* Smoker or drinker
* Refuse or incompetence for informed consent
18 Years
FEMALE
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Chung Pui Wah Jacqueline
Associate Professor (Clinical)
Locations
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Chung Pui Wah, Jacqueline
Hong Kong, , China
Countries
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Central Contacts
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Facility Contacts
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Chung PW Jacqueline
Role: primary
Other Identifiers
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2025.106
Identifier Type: -
Identifier Source: org_study_id