The Efficacy of Acupuncture-type Transcutaneous Electrical Nerve Stimulation as an Adjunct Analgesic in Reducing Pain During Ultrasound-guided Manual Vacuum Aspiration: A Prospective, Single- Blinded Two-arm Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- VAS pain score
研究概览
简要总结
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.
详细描述
Randomization process and blinding of clinician For those who consented to the study, they will be randomly assigned preoperatively to receive "acu-TENS" or "sham acu-TENS" according to a computer-generated random number series by an independent research nurse who is not in our team in a 1:1 ratio. Prior to the onset of the study, sequentially numbered (written on top) non-opaque envelopes containing treatment modality, (i) intervention group (Group A): acu-TENS in USG-MVA (ii) controlled group (Group B): sham acu-TENS in USG-MVA will be also prepared by an independent research nurse. On opening the envelope, the study nurse will record the envelope number and the randomization group assigned in patient recruitment password protected electronic file. The assigned envelope number will then be documented in a second electronic password protected file which will be used to document procedure details, patients' details, procedure outcome and investigation assessments.
The Firstbeat Body-guard 3 device to measure HRV will be applied 1 hour before the procedure and will remain in place for 1 hour after the procedure.
15 minutes before MVA, after the clinician has applied the TENS pads on specific acupoints, and connected the pads to the TENS machine, the study nurse will be responsible to (i) intervention group (Group A): turn on the TENS machine or (ii) controlled group (Group B): pretend to turn on the TENS machine. 15 minutes after MVA, the study nurse will (i) intervention group (Group A): turn off the TENS machine or (ii) controlled group (Group B): pretend to turn off the TENS machine. After that, the clinician will disconnect the wires and remove the pads. Hence, the clinician will be blinded throughout the process.
The study nurse will not be present during the operative procedure, nor will she be involved in the any investigations. Moreover, another team of gynaecologist and nursing staff will help with the follow-up phone calls to avoid performance and measurement biases and the problem of automatic unblinding.
USG-MVA procedure All women will be asked to fill in the STAI questionnaire before they come to hospital. Once admitted, all women will be given 400µg of misoprostol orally for cervical priming, 2-3 hours before the procedure. 500mg of naproxen will be given 60 min before the procedure. Paracetamol or codeine will be used as an alternative to naproxen in case of allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above;
- •Patient diagnosed with first-trimester miscarriage, who is eligible for USG-MVA;
- •Patient diagnosed with incomplete miscarriage after medical treatment;
- •Willing to be randomized to receive acupuncture.
排除标准
- •a. Patient not eligible for USG-MVA i. Miscarriage > 12 weeks of gestation; or ii. Pregnancy of unknown origin; or iii. Known narrowing of the cervical canal; or iv. Multiple uterine fibroids; or v. Congenital uterine anomalies; or vi. Active pelvic infection; or vii. Bleeding disorder; or viii. Inability to tolerate pelvic examination; or ix. History of allergy to misoprostol
- •b. Patient not eligible for acu-TENS i. Poor skin integrity at the acupuncture site, such as open wound, infections, unknown mass, bleeding tendency; or ii. Allergic to external alcohol; or iii. Emotionally unstable or tend to restlessness (to avoid tear-off of pads).
- •c. Patient refusal
研究组 & 干预措施
Au-TENS group
Women will receive acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA.
干预措施: Acu-TENS (Device)
Sham acu-TENS group
Women will receive sham acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA. In the sham acu-TENS, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.
干预措施: Sham acu-TENS (Device)
结局指标
主要结局
VAS pain score
时间窗: Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA)
Women will be asked to move the cursor along the VAS ruler, which does not have markings other than '0' and '10', to indicate her pain level at different time intervals. With a change of more than or equal to 10 for the 100 mm VAS, the analgesic intervention is clinical important (Myles et al., 2017).
次要结局
- Potential benefits(1 year post USG-MVA)
- Stress level measured by STAI questionnaire(2 hours before and 1 hour after USG-MVA)
- Stress level measured by saliva cortisol(2 hours before, right after, and 30 minutes after USG-MVA)
- Blood pressure(Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA))
- VAS Anxiety Score(Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA))
- Patient Satisfaction Score(One hour after USG-MVA)
- Client satisfaction questionnaire (CSQ8)(One hour after USG-MVA)
- Adverse events(1 month post USG-MVA)
- Heart rate and heart rate variability(One hour before USG-MVA to one hour after USG-MVA)
- Patient pain score(Right after USG-MVA)
- Patient compliance index(Right after USG-MVA)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong