Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411054
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-29
Brief Title:
The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Surgeons 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
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 Surgeons 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
Detailed 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 11 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 doctors 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 05 cm at the cervical-vaginal juncture at 4 5 7 and 8 oclock 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 20 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 ie 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 abandonedFor 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
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 doctors 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 05 cm at the cervical-vaginal juncture at 4 5 7 and 8 oclock 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 20 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 ie 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 abandonedFor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None