ACU-TENS on Pain and Stress Reduction Before and During TUGOR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acu-TENS, Sham acu-TENS.
- Who it may be relevant to
- Registry conditions: Oocyte Retrieival and Post Operative Pain Control, Acupuncture. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acupuncture-type Transcutaneous Electrical Nerve Stimulation on Pain and Stress Reduction Before and During Transvaginal Ultrasound-guided Oocyte Retrieval: a Randomized Controlled Trial
Overview
Objectives: To demonstrate the use of acupuncture-type transcutaneous electrical nerve stimulation (acu-TENS) during transvaginal ultrasound-guided oocyte retrieval (TUGOR) will reduce 50% of the intensity of pain experienced by women. 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.
Interventions
- Other 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 pa - Other 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.
Primary outcome measures
- Pain VAS (minimum 0 to maximum 100) [Time frame: Before admission and 1 hour before TUGOR, when switch to contra-lateral ovary, shortly after TUGOR, and 30 minutes, 1 hour, 2 hours, and 4 hours after TUGOR]
Secondary outcome measures (9)
- Satisfaction score (minimum 0 to maximum 100) [Time frame: 4 hour after TUGOR]
- Patient compliance index (minimum 1 to maximum 5) [Time frame: 4 hour after TUGOR]
- Patient pain score (minimum 0 to maximum 4) [Time frame: 4 hour after TUGOR]
- Additional use of analgesia [Time frame: 4 hour after TUGOR]
- Spielberger's State Anxiety Inventory (minimum 20 to maximum 80) [Time frame: Before admission and 1 hour after TUGOR]
- 12-item General Health Questionnaire (minimum 12 to maximum 48) [Time frame: Before admission.]
- Beck Depression Inventory (minimum 0 to maximum 63) [Time frame: Before admission.]
- Saliva cortisol [Time frame: Before admission and 1 hour after TUGOR]
- Number of participants with treatment-related adverse events [Time frame: Before admission.]
Eligibility criteria
Inclusion criteria
- Women undergoing IVF-ET cycles are to be recruited from the Assisted Reproduction Technology unit in the Prince of Wales Hospital
Exclusion criteria
- Patient not eligible for acu-TENS
- Patient with severe cardiac and respiratory disease history
- Smoker or drinker
- Refuse or incompetence for informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chung Pui Wah, Jacqueline — Hong Kong
Identifiers
NCT: NCT06910540 · 2025.106