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NCT Number: NCT06910540

ACU-TENS on Pain and Stress Reduction Before and During TUGOR

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.

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Key information

Conditions

Oocyte Retrieival and Post Operative Pain Control Acupuncture Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chung Pui Wah, Jacqueline

Hong Kong, China

Location status: Recruiting

Location contact

Chung PW Jacqueline

CONTACT

[email protected]

35053489

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acu-TENS

Other

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

Other

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 outcomes

  1. 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

    Research assistance who is not involved in the TUGOR will ask patients about the pain level by a ruler on 100mm visual analogous scale (VAS; 0 mm = no pain, 100mm = worst pain). Before operation, patient will be asked to give VAS pain and anxiety before admission and 1 hour before TUGOR. This is to assess the baseline pain perception for the patients. VAS for vaginal and abdominal pain and will be rated by patient when the surgeon switch to contra-lateral ovary and shortly after TUGOR. Patient will be asked to rate the abdominal and vaginal pain again 30 minutes, 1 hour, 2 hours, and 4 hours after TUGOR (before discharge). With a change of more than or equal to 10 for the 100 mm VAS, the analgesic intervention is clinical important.

Secondary outcomes

  1. Satisfaction score (minimum 0 to maximum 100)

    Time frame: 4 hour after TUGOR

    Patient will be asked to give the satisfaction score regarding the pain control of TUGOR: excellent, satisfactory, fair and unsatisfactory. For those patients had undergone previous oocyte retrieval by conscious sedation alone, they will ask whether they prefer the present treatment modality or not.

  2. Patient compliance index (minimum 1 to maximum 5)

    Time frame: 4 hour after TUGOR

    To validate the VAS pain score rated by patients, surgeons will rate the patient compliance index. For the patient compliance index, it is a 5-point Likert scale rated from 1 (fully co-operation) to 5 (no co-operation, procedure abandoned).

  3. Patient pain score (minimum 0 to maximum 4)

    Time frame: 4 hour after TUGOR

    To validate the VAS pain score rated by patients, surgeons will rate the patient pain score. For the patient pain score, it is a 5-point Likert scale rated from 0 (patient did not show any sign of pain) to 4 (patient did not let the procedure continue which was demonstrated by verbal or bodily expression).

  4. Additional use of analgesia

    Time frame: 4 hour after TUGOR

    The additional of analgesic during and after TUGOR will be recorded.

  5. Spielberger's State Anxiety Inventory (minimum 20 to maximum 80)

    Time frame: Before admission and 1 hour after TUGOR

    Basal anxiety level will be assessed by the Spielberger's State Anxiety Inventory (STAI; both the S-AD questionnaire for stress level and T-AI questionnaire for traits). As stress state may affect the pain level, S-AD questionnaire will be done again after TUGOR.

  6. 12-item General Health Questionnaire (minimum 12 to maximum 48)

    Time frame: Before admission.

    Basal anxiety level will be assessed by the 12-item General Health Questionnaire (GHQ-12).

  7. Beck Depression Inventory (minimum 0 to maximum 63)

    Time frame: Before admission.

    Basal anxiety level will be assessed by the Beck Depression Inventory (BDI).

  8. Saliva cortisol

    Time frame: Before admission and 1 hour after TUGOR

    Saliva cortisol would be utilized as an objective indicator of our patient's stress level while undergoing TUGOR. Saliva cortisol will be measured before and immediately after TUGOR procedures.

  9. Number of participants with treatment-related adverse events

    Time frame: Before admission.

    Patients will be invited to try on the TENS pads to see if they are allergic to it. This will be assessed by observing if their skin may become red and irritated.

    Any treatment-related dizziness, headache, tiredness will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Wah Jacqueline Chung

CONTACT

[email protected]

+852 3505 1537

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Acupuncture-type Transcutaneous Electrical Nerve Stimulation on Pain and Stress Reduction Before and During Transvaginal Ultrasound-guided Oocyte Retrieval: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 4, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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