NCT03472430

Brief 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. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 25, 2018

Last Update Submit

February 26, 2019

Conditions

Transcutaneous Electric Nerve StimulationOocyte Retrieval

Keywords

Oocyte RetrievalTranscutaneous Electric Nerve StimulationPain reliefConscious sedation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day on the day of the retrieval procedure

Secondary Outcomes (2)

  • Side effects

    1 day on the day of the retrieval procedure

  • Women satisfaction

    1 day on the day of the retrieval procedure

Study Arms (2)

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

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

Device: TENS machine with electrodes not emitting any impulses.

Interventions

Transcutaneous electrical nerve stimulationDEVICE

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.

Also known as: Endomed 482
Treatment group
TENS machine with electrodes not emitting any impulses.DEVICE

TENS machine with electrodes not emitting any impulses.

Placebo group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who undergo transvaginal oocyte retrieval

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

Location

Related Publications (9)

  • 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.

    PMID: 10548622BACKGROUND

  • Ng 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.

    PMID: 11006189BACKGROUND

  • Ng 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.

    PMID: 11287024BACKGROUND

  • Lier 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.

    PMID: 24725465BACKGROUND

  • Kwan 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.

    PMID: 23440796BACKGROUND

  • Johnson M. Watson T. Transcutaneous electrical nerve stimulation, Electrotherapy: Evidence-based Practice. , 2008 Edinburgh Churchill Livingstone (pg. 253 -96)

    BACKGROUND

  • 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.

    PMID: 26701166BACKGROUND

  • Lison 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.

    PMID: 28079781BACKGROUND

  • Wong 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.

    PMID: 30971304DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Ernest HY Ng, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 21, 2018

Study Start

May 4, 2018

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)