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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590146
• Other study ID #: 22893
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: September 28, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain Management
• Pregnancy Termination

Intervention

Behavioral:
• Non-pharmacologic pain control adjuncts

Locations

Country	Name	City	State
United States	University of Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No