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Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion

NCT ID: NCT02590146

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Termination Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Non-pharmacologic pain control adjuncts

Intervention Type BEHAVIORAL

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Non-pharmacologic pain control adjuncts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Hawaii

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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22893

Identifier Type: -

Identifier Source: org_study_id