Cold Compress for Pain Associated With Intrauterine Device Insertion

NCT02898831 | Completed

• 1 other identifier: HM20004308
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be a prospective randomized controlled trial comparing cold compression to no intervention immediately prior to and during intrauterine device insertion. Subjects will be randomized to cold compress or no intervention (standard practice in our clinics). Following IUD insertion they will complete a validated pain scale survey regarding their pre-procedure and intra-procedure pain.

Conditions

Intrauterine Device; Cold Compress

Outcome Measures

Primary Outcomes (1)

• Procedural Pain

  Primary outcome will be the difference in patient's perception of pain before and during intrauterine device insertion. This will be defined based on a pre and post-procedure survey using a 10-point visual analogue scale.

  During IUD insertion (second to minutes)

Study Arms (2)

Control/No Intervention

NO INTERVENTION

Standard clinical procedure with intrauterine device insertion involving no heated/cold compresses on the abdomen during insertion.

Cold Compress/Experimental

EXPERIMENTAL

Cold compress (intervention) placed on abdomen just before IUD insertion and remains throughout insertion. Pain scale and survey completed following insertion regarding pre-procedure and intra-procedure pain.

Other: Cold Compress

Interventions

Cold Compress OTHER

Cold Compress placed on lower abdomen prior to and during IUD insertion.

Also known as: Ice Pack

Cold Compress/Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-pregnant women,
• years of age or older,
• desire IUD placement.

You may not qualify if:

• under the age of 18
• decisionally impaired
• prisoners

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

VCU Health System- Stony Point Clinic

Richmond, Virginia, 23235, United States

Location

VCU Health System Nelson Clinic

Richmond, Virginia, 23298, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 18, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)