Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06411054 |
| Other study ID # |
CRE-2023.578 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
The USG-MVA procedure will be carried out by doctors with similar surgical experience who
have carried out at least 25 USG-MVA procedures independently. The USG-MVA will be carried
out using a 60-ml charged syringe (MedGyn Aspiration Kit IV, 022511) (Addison, IL, USA) with
a flexible curette (size 4-7 mm, subject to the doctor's discretion) attached to it.
Paracervical block will be carried out using a 23-gauge dental needle syringe to inject 5 ml
of 2% lidocaine into a depth of 0.5 cm at the cervical-vaginal juncture at 4, 5, 7 and 8
o'clock position to reach the uterosacral ligaments. A tenaculum will be used to hold the
cervix if necessary. Voluson E730 Expert USG system will be used for transabdominal USG
during MVA. During the procedure, 5-ml of local lidocaine gel will be applied to the cervical
canal and over the end of the MVA catheter tip during the insertion. A research assistant
will help the patient with filling in an intra-procedure VAS questionnaire.
The USG-MVA procedure will be stopped as soon as the operating clinician is satisfied that
the uterine cavity is empty. Products of conception will be sent for histological evaluation
and cytogenetic analysis if clinically indicated. Postoperative complications, including
significant bleeding requiring blood transfusion, uterine perforation and infection and
side-effects such as nausea, vomiting, dizziness, drowsiness, shortness of breath and dry
mouth or eyes from the medication and their severity will be documented.
Acu-TENS treatment and Sham acu-TENS treatment All acu-TENS and sham acu-TENS treatments will
be performed on site in the same manner by a clinician who follows a standard approach to
describe the intervention to participants.
After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on
the acupoints SP6, ST36, LI4, LR3, 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 4-12mA, and pulse width of
300µS will be delivered continually for 45 minutes (i.e. from 15 minutes before starting the
MVA to 15 minutes after the procedure has completed).
In the sham acu-TENS group, TENS pads will be placed on the same acupoints, connected to the
machine, but without electric current.
Measurement of Pain Individual pain scores, measured by the visual analog scale (VAS), is
recorded before taking misoprostol, right before the surgery, during (during cannula
insertion, and for every suction), and after USG-MVA (0 min, 15 min, 30 min, and 1-hour
post-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.
To validate the VAS pain score rated by patients, surgeons will rate the patient compliance
index and patient pain score. 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).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).
Measurement of stress
1. Blood pressure will be recorded before taking misoprostol, right before the surgery,
during (during cannula insertion, and for every suction), and after USG-MVA (0 min, 15
min, 30 min, and 1-hour post-MVA).
2. Heart rate and HRV one hour before USG-MVA to one hour after USG-MVA will be measured
using Firstbeat Bodyguard 3 devices. Studies have shown that in acute pain, with
ascending nociception, segmental spinal reflexes are recruited to activate the
sympathetic system, resulting in increased peripheral resistance, heart rate, and stroke
volume). HRV is a non-invasive measurement of the variation in time between consecutive
heartbeats which provides information about the balance between the sympathetic
(fight-or-flight) and parasympathetic (rest-and-digest) branches of the autonomic
nervous system. Under high stress, amygdala activation initiates the
hypothalamic-pituitary-adrenal axis (HPA axis) response and parasympathetic withdrawal.
This enhanced stress load is expressed as decreased cardiac vagal activity. HRV has also
been found to be a useful in evaluating pain response and can potentially overcome some
of the challenges of quantifying pain.
3. Saliva will be collected for cortisol analysis before, immediately after, and 15 minutes
after MVA. Cortisol is a stress hormone. We test the cortisol level in saliva instead of
blood to avoid the stress brought by blood drawing which will result in elevated
cortisol levels. Studies indicate elevated saliva cortisol levels in pain, for example,
fibromyalgia and myofascial pain. Vice versa, when pain is relieved, saliva cortisol
level will decrease. For example, pain is relieved by dance and yoga in functional
abdominal pain disorders.
4. Participants will be asked to fill in the STAI questionnaire before and after USG-MVA.
STAI is a 40-items scale which used 4-point Likert scale ranged from almost never to
almost always. The higher scoring indicates greater level of anxiety. It consists of two
parts, the S-AD questionnaire for stress level and the T-AI questionnaire for traits.
The validated Chinese version of STAI was used to measure the changing psychological
status before and after USG-guided MVA, with a score ranging from 20 to 80. Participants
will be asked to fill in both parts when they arrived at the hospital. This can give a
better baseline anxiety index. A stress state may affect the pain level. Hence, after
the USG-MVA procedure, the S-AD questionnaire will be done again.
Measurement of anxiety Participants will be asked to rate the VAS-anxiety before and after
the USG-MVA procedure.
Measurement of patient satisfaction Participants will be asked to complete a client
satisfaction questionnaire (CSQ8) after USG-MVA. CSQ8 contains eight items including the
concern of quality of service, kind of service, outcome of service, extent in meeting their
need, recommendation to friend, amount of help, effectiveness in dealing the problem, overall
satisfaction and willingness to use the service again. It is rated by four-point Likert
scale, which scores ranged from 8 to 32. The higher scores indicate greater satisfaction with
the service or treatment. Participants will also be asked to rate their satisfaction on the
MVA service from 0 score (lowest satisfaction) to 100 score (highest satisfaction) by a 100mm
scale.
Recording the safety profile and potential benefits Follow-up phone calls will be made 1
month after the procedure to ask for possible side effects. Any serious adverse effects will
be recorded.
