NCT03494842

Brief Summary

To study the effectiveness of the pain relief method of transcutaneous electrical nerve stimulation (TENS) for women who will undergo suction evacuation under conscious sedation for first trimester termination of pregnancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

March 5, 2018

Last Update Submit

April 10, 2018

Conditions

Pregnancy, AbdominalTermination of PregnancyPain, Nerve

Keywords

TENSpain reliefSTOPsurgical abortion

Outcome Measures

Primary Outcomes (1)

  • To assess the change of 100-point visual analogue pain scale in 3 time points

    To measure patient's pain intensity before and after suction TOP by using The Visual Analogue Scale (VAS) consists of a straight line length of 100 mm with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. This tool was first used in psychology by Freyd in 1923.

    Patient will be asked for the pain intensity by using the 100 mm linear VAS 5 minutes before receiving the active TENS/ placebo TENS before the start of suction evacuation, reassess 20 minutes later and 1 hour after operation.

Secondary Outcomes (2)

  • To assess the change of Anxiety level of the patients in 3 time points by using State-Trait Anxiety Inventory Questionnaire to record patient's anxiety level.

    Patient will be asked for the anxiety level by using STAI 5 minutes before receiving the active TENS/ placebo TENS before the start of suction evacuation, reassess 20 minutes later and 1 hour after operation.

  • To assess the difficulty of the operation

    The surgeon will be asked to fill the assessment form right after the suction evacuation operation immediately.

Study Arms (2)

the active TENS group

ACTIVE COMPARATOR

Transcutaneous nerve stimulation (TENS)

Device: Transcutaneous nerve stimulation (TENS)

the placebo TENS group

PLACEBO COMPARATOR

Placebo Transcutaneous nerve stimulation (TENS)

Device: Placebo Transcutaneous nerve stimulation (TENS)

Interventions

Transcutaneous nerve stimulation (TENS)DEVICE

The active TENS unit (delivers electrical stimulation) with indicator light

Also known as: the active TENS group
the active TENS group
Placebo Transcutaneous nerve stimulation (TENS)DEVICE

the placebo TENS unit (delivers no electrical stimulation) with indicator light

Also known as: the placebo TENS group
the placebo TENS group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who has up to 12 weeks gestation on the day of STOP
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese aged 18 years or above and mentally competent
  • Up to 12 weeks gestation on the day of STOP
  • Size of the uterus on pelvic examination compatible with estimated duration of pregnancy, or dating confirmed with ultrasound scan
  • Normal general and gynecological examination

You may not qualify if:

  • Skin damage or allergy at site of TENS pads application
  • Previous experience with TENS
  • History of pacemarker insertion
  • History of severe respiratory or cardiac disease
  • Severe and recurrent liver disease
  • Allergic to lignocaine
  • Myasthenia gravis
  • Psychiatric conditions requiring medication
  • Disorders that constitute contraindications to use of prostaglandins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

  • Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.

    PMID: 2710563BACKGROUND

  • Wong CY, Ng EH, Ngai SW, Ho PC. A randomized, double blind, placebo-controlled study to investigate the use of conscious sedation in conjunction with paracervical block for reducing pain in termination of first trimester pregnancy by suction evacuation. Hum Reprod. 2002 May;17(5):1222-5. doi: 10.1093/humrep/17.5.1222.

    PMID: 11980742BACKGROUND

  • 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

  • Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.

    PMID: 24953072BACKGROUND

  • Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

    PMID: 14622708BACKGROUND

MeSH Terms

Conditions

Pregnancy, AbdominalNeuralgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pregnancy, EctopicPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Keedon Wong, MBBS

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
After the written informed consent is obtained, subjects will be randomly allocated into one of the two groups: (a) the active TENS group and (b) the placebo TENS group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Dr.)

Study Record Dates

First Submitted

March 5, 2018

First Posted

April 11, 2018

Study Start

April 26, 2018

Primary Completion

January 22, 2020

Study Completion

March 22, 2020

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

HK(1)