Transcutaneous Electric Nerve StimulationNCT03472430
Transcutaneous Electrical Nerve Stimulation During Transvaginal Oocyte Retrieval
A study testing Transcutaneous electrical nerve stimulation and TENS machine with electrodes not emitting any impulses. in people with Transcutaneous Electric Nerve Stimulation and Oocyte Retrieval, run by The University of Hong Kong at 1 site in China.
Trial summary
This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Transcutaneous Electric Nerve Stimulation, Oocyte Retrieval
- What is being tested?
- Transcutaneous electrical nerve stimulation and TENS machine with electrodes not emitting any impulses.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2018to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who undergo transvaginal oocyte retrieval
Who cannot join
- There is only one ovary
- Oocyte retrieval performed on one ovary only
- There are less than three follicles >=16mm in diameter
- Allergic to pethidine or midazolam
- Previous experience with TENS
- Skin damage or allergy at site of TENS pads application
- History of pacemaker insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Relief During Transvaginal Oocyte Retrieval Using Conscious Sedation
This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.
Read the detailed description
Women who are indicated to undergo IVF in our center will be assessed for eligibility for the study. Written consent will be obtained from those who agreed to join the study.
Eligible women recruited will be randomized according to a computer-generated randomization list prepared by a designated research staff into one of the two groups on the day of oocyte retrieval
- Patient with both conscious sedation and active TENS
- Patient with conscious sedation and placebo TENS
Blinding Both the women and the physician performing the procedure will be blinded from the group allocation.
Checking of effectiveness of blinding will be done by asking the patient and the physician after the procedure as to which group they think the women is in.
The procedure Women will receive ovarian stimulation according to the departmental Standard Operating Procedures. Ovarian stimulation will be monitored by ultrasound. Human chorionic gonadotrophin or an agonist (decapeptyl) will be given when the dominant follicle is at least 18mm and there are three more follicles of at least 16mm. Oocyte retrieval will then be arranged 36 hours later.
Prior to oocyte retrieval, two sets of self-adhesive electrodes will be placed on the women back on each side of the spine at T10 to S4 level. Instructions on how to titrate the TENS amplitude to the desired level that gives a strong non-painful electrical paraesthesia will be given to the women by the research nurse who is unaware of the group allocation. TENS therapy will start 5 minutes before the procedure and stop 5 minutes after the removal of oocyte aspiration needle. The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses s-. The women in the treatment group will be given a TENS machine with electrodes emitting impulses while those in the placebo group will be given a TENS machine with electrodes that is not emitting any impulses.
The woman lies on the operative bed in a lithotomy position. 25mg Pethidine and 5mg Diazepam will be given intravenously. The blood pressure and pulse of the woman are checked after the drug administration and the oxygen saturation is monitored continuously throughout the procedure. 10ml 1% lignocaine is injected to the paracervical region by the operating surgeon with a 21-gauge needle after cleansing the vagina and cervix with chlorhexidine. Under transvaginal ultrasound guidance, a 16-gauge ovum aspiration needle is introduced. Aspiration of follicles is performed with a suction pressure of 100 mmHg.
- Being tested
- Transcutaneous electrical nerve stimulation, TENS machine with electrodes not emitting any impulses.
- Keywords
- Oocyte Retrieval, Transcutaneous Electric Nerve Stimulation, Pain relief, Conscious sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called Endomed 482
The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses.
TENS machine with electrodes not emitting any impulses.Device
TENS machine with electrodes not emitting any impulses.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Transcutaneous electrical nerve stimulation machine, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle Receives: Device: Transcutaneous electrical nerve stimulation |
| Placebo group | Sham comparator | TENS machine with electrodes not emitting any impulses, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle Receives: Device: TENS machine with electrodes not emitting any impulses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The women will be asked to rate the pain according to a 100mm linear visual analogue scale. The visual analogue scale range from 0 to 100, 0 indicating no pain and 100 indicating maximum pain. A small value in the visual analogue scale indicates lower pain levels, therefore better. It is a single level indicated by the patients.
Measured: 1 day on the day of the retrieval procedure
Secondary outcomes (2)
Side effects
Side effects experienced by the women
Measured: 1 day on the day of the retrieval procedure
Women satisfaction
Patient's satisfaction towards pain relief will be assessed before discharge. They will be rated as 5, 'excellent'; 4, 'satisfactory'; 3, 'fair'; 2,'not very satisfactory' and 1, 'totally unsatisfactory.
Measured: 1 day on the day of the retrieval procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start4 May 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernest HY Ng, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472430
- Sponsor's protocol ID
- TENS TUGOR ver 1
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng EH, Tang OS, Chui DK, Ho PC. A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF. Hum Reprod. 1999 Nov;14(11):2783-7. doi: 10.1093/humrep/14.11.2783.
PubMed 10548622Ng EH, Tang OS, Chui DK, Ho PC. Comparison of two different doses of lignocaine used in paracervical block during oocyte collection in an IVF programme. Hum Reprod. 2000 Oct;15(10):2148-51. doi: 10.1093/humrep/15.10.2148.
PubMed 11006189Ng EH, Chui DK, Tang OS, Ho PC. Paracervical block with and without conscious sedation: a comparison of the pain levels during egg collection and the postoperative side effects. Fertil Steril. 2001 Apr;75(4):711-7. doi: 10.1016/s0015-0282(01)01693-4.
PubMed 11287024Lier MC, Douwenga WM, Yilmaz F, Schats R, Hompes PG, Boer C, Mijatovic V. Patient-Controlled Remifentanil Analgesia as Alternative for Pethidine with Midazolam During Oocyte Retrieval in IVF/ICSI Procedures: A Randomized Controlled Trial. Pain Pract. 2015 Jun;15(5):487-95. doi: 10.1111/papr.12189. Epub 2014 Apr 12.
PubMed 24725465Kwan I, Bhattacharya S, Knox F, McNeil A. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD004829. doi: 10.1002/14651858.CD004829.pub3.
PubMed 23440796Johnson M. Watson T. Transcutaneous electrical nerve stimulation, Electrotherapy: Evidence-based Practice. , 2008 Edinburgh Churchill Livingstone (pg. 253 -96)
Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.
PubMed 26701166Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.
PubMed 28079781Wong QHY, Lui MW, Yung SSF, Ko JKY, Li RHW, Ng EHY. Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):205. doi: 10.1186/s13063-019-3227-5.
PubMed 30971304
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Relief During Transvaginal Oocyte Retrieval Using Conscious Sedation
- ClinicalTrials.gov ID
- NCT03472430
- Acronym / sponsor ID
- TENS TUGOR ver 1
- Keywords
- Oocyte Retrieval, Transcutaneous Electric Nerve Stimulation, Pain relief, Conscious sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.
Detailed description
Women who are indicated to undergo IVF in our center will be assessed for eligibility for the study. Written consent will be obtained from those who agreed to join the study.
Eligible women recruited will be randomized according to a computer-generated randomization list prepared by a designated research staff into one of the two groups on the day of oocyte retrieval
- Patient with both conscious sedation and active TENS
- Patient with conscious sedation and placebo TENS
Blinding Both the women and the physician performing the procedure will be blinded from the group allocation.
Checking of effectiveness of blinding will be done by asking the patient and the physician after the procedure as to which group they think the women is in.
The procedure Women will receive ovarian stimulation according to the departmental Standard Operating Procedures. Ovarian stimulation will be monitored by ultrasound. Human chorionic gonadotrophin or an agonist (decapeptyl) will be given when the dominant follicle is at least 18mm and there are three more follicles of at least 16mm. Oocyte retrieval will then be arranged 36 hours later.
Prior to oocyte retrieval, two sets of self-adhesive electrodes will be placed on the women back on each side of the spine at T10 to S4 level. Instructions on how to titrate the TENS amplitude to the desired level that gives a strong non-painful electrical paraesthesia will be given to the women by the research nurse who is unaware of the group allocation. TENS therapy will start 5 minutes before the procedure and stop 5 minutes after the removal of oocyte aspiration needle. The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses s-. The women in the treatment group will be given a TENS machine with electrodes emitting impulses while those in the placebo group will be given a TENS machine with electrodes that is not emitting any impulses.
The woman lies on the operative bed in a lithotomy position. 25mg Pethidine and 5mg Diazepam will be given intravenously. The blood pressure and pulse of the woman are checked after the drug administration and the oxygen saturation is monitored continuously throughout the procedure. 10ml 1% lignocaine is injected to the paracervical region by the operating surgeon with a 21-gauge needle after cleansing the vagina and cervix with chlorhexidine. Under transvaginal ultrasound guidance, a 16-gauge ovum aspiration needle is introduced. Aspiration of follicles is performed with a suction pressure of 100 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Transcutaneous electrical nerve stimulationTranscutaneous electrical nerve stimulation machine, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle |
| Placebo group | Sham comparator | Device: TENS machine with electrodes not emitting any impulses.TENS machine with electrodes not emitting any impulses, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who undergo transvaginal oocyte retrieval
Key exclusion criteria (7 listed)
- There is only one ovary
- Oocyte retrieval performed on one ovary only
- There are less than three follicles >=16mm in diameter
- Allergic to pethidine or midazolam
- Previous experience with TENS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulationAlso: Endomed 482The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses. | Device | Treatment group |
| TENS machine with electrodes not emitting any impulses.TENS machine with electrodes not emitting any impulses. | Device | Placebo group |
Primary outcome
Pain level
Time frame: 1 day on the day of the retrieval procedure
The women will be asked to rate the pain according to a 100mm linear visual analogue scale. The visual analogue scale range from 0 to 100, 0 indicating no pain and 100 indicating maximum pain. A small value in the visual analogue scale indicates lower pain levels, therefore better. It is a single level indicated by the patients.
2 secondary outcomes
Side effects
Time frame: 1 day on the day of the retrieval procedure
Women satisfaction
Time frame: 1 day on the day of the retrieval procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Background: PubMed 10548622Ng EH, Tang OS, Chui DK, Ho PC. A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF. Hum Reprod. 1999 Nov;14(11):2783-7. doi: 10.1093/humrep/14.11.2783.
- Background: PubMed 11006189Ng EH, Tang OS, Chui DK, Ho PC. Comparison of two different doses of lignocaine used in paracervical block during oocyte collection in an IVF programme. Hum Reprod. 2000 Oct;15(10):2148-51. doi: 10.1093/humrep/15.10.2148.
- Background: PubMed 11287024Ng EH, Chui DK, Tang OS, Ho PC. Paracervical block with and without conscious sedation: a comparison of the pain levels during egg collection and the postoperative side effects. Fertil Steril. 2001 Apr;75(4):711-7. doi: 10.1016/s0015-0282(01)01693-4.
- Background: PubMed 24725465Lier MC, Douwenga WM, Yilmaz F, Schats R, Hompes PG, Boer C, Mijatovic V. Patient-Controlled Remifentanil Analgesia as Alternative for Pethidine with Midazolam During Oocyte Retrieval in IVF/ICSI Procedures: A Randomized Controlled Trial. Pain Pract. 2015 Jun;15(5):487-95. doi: 10.1111/papr.12189. Epub 2014 Apr 12.
- Background: PubMed 23440796Kwan I, Bhattacharya S, Knox F, McNeil A. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD004829. doi: 10.1002/14651858.CD004829.pub3.
- BackgroundJohnson M. Watson T. Transcutaneous electrical nerve stimulation, Electrotherapy: Evidence-based Practice. , 2008 Edinburgh Churchill Livingstone (pg. 253 -96)
- Background: PubMed 26701166Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.
- Background: PubMed 28079781Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.
- Derived from this study: PubMed 30971304Wong QHY, Lui MW, Yung SSF, Ko JKY, Li RHW, Ng EHY. Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):205. doi: 10.1186/s13063-019-3227-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest HY Ng, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and TENS machine with electrodes not emitting any impulses. in people with Transcutaneous Electric Nerve Stimulation and Oocyte Retrieval, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 1 day on the day of the retrieval procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472430, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.