NCT02590146

Brief Summary

This study will examine the use of non-pharmacologic pain control techniques and pain-management counseling as an additional tool for reducing pain during first trimester aspiration abortion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

October 27, 2015

Last Update Submit

September 28, 2016

Conditions

Pregnancy TerminationPain Management

Outcome Measures

Primary Outcomes (1)

  • Difference in overall pain score during procedure between control and intervention group

    Patients will complete a visual analog scale to score their overall pain for the procedure.

    Collected within 1 minute of procedure completion

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in this group will participate in pain management counseling and choose non-pharmacologic pain control supports to use during their procedure in addition to the standard of care pain management offered in the office

Behavioral: Non-pharmacologic pain control adjuncts

Control group

NO INTERVENTION

Patients in this group will receive standard of care pain management offered in the office.

Interventions

Non-pharmacologic pain control adjunctsBEHAVIORAL
Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking, able to read and understand consent form
  • Age 18 + (minors eligible with parental consent)
  • Seeking in-office aspiration termination of pregnancy
  • Gestational age less than 14 weeks

You may not qualify if:

  • Not able to read or understand English
  • Unable to understand consent
  • Minors without parental consent
  • Requesting narcotic or sedative analgesics
  • Currently incarcerated
  • Gestational age greater than 14 weeks
  • Seeking medication abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)