Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office (MIUD)

September 26, 2021 updated by: Glenmarie Matthews, MD, Rutgers, The State University of New Jersey
This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized control trial conducted in the gynecology clinic inside Robert Wood Johnson University Hospital (RWJ) and the offices of Rutgers Medical Group Obstetrics and Gynecology (RMG). A family planning attending alone at RMG or accompanied by obstetrics and gynecology (Ob/Gyn) residents at RWJ will perform all IUD insertions during this study period. Patients scheduled for an IUD, either the Mirena® (levonorgestrel-releasing intrauterine system 52 mg) or Paragard® (intrauterine copper contraceptive), at both locations will be instructed to take ibuprofen 30 minutes prior to their procedure.

Enrollment will occur during all weekdays at both RWJ and RMG. Eligible women will be enrolled if they are willing to be randomized. Written consent will be obtained from each participant.

After the consent process is completed, the patients will complete a survey which includes their demographic information, if they are currently menstruating, and their pregnancy history while sitting in the waiting room. The patient will also complete a 10 point visual analog scale (VAS) to report her baseline pain and a State Trait Anxiety Inventory (STAI). Vital signs will be recorded with an automated machine.

Participants will then be randomized to routine pain control measures or routine pain control measures plus music. Randomization will be completed by the study staff, who will open sequentially numbered, sealed, opaque envelopes. Allocation will be in a 1:1 ratio. Routine pain control will include instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. It will be noted whether patients actually take ibuprofen or not by the study staff. Patients randomized to receive music in addition to routine pain control measures, will be given a headset that will be plugged into the PI phone to play the preselected classical music. Patients will control the volume. Control group participants also will receive a headset. The headsets will not be noise cancelling.

A study staff member will be present in the room throughout the duration of the procedure in addition to the physician performing the actual insertion of the IUD. This study staff member will complete a procedure information sheet including vitals, type of IUD inserted, and the VAS and STAI at several points of the procedure (immediately prior to the procedure, point of speculum insertion, point of tenaculum placement, point of IUD insertion, and 5 minutes post-procedure).

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who have an appointment for IUD insertion at either RWJ or RMG
  • Women who are able to read and write in English or Spanish
  • Age equal to or greater than 18 years

Exclusion Criteria:

  • Contraindications to IUD placement: Active pelvic infection, pregnancy, known distortion of uterine cavity, Wilson's disease (Paragard® only), breast cancer (Mirena® only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine pain control
The routine pain control group will receive instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants.
Experimental: Routine pain control plus music
Patients randomized to receive music in addition to routine pain control measures, will be instructed to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. Preselected classical music will be played for this group throughout the procedure.
Behavioral: Preselected classical music
Preselected classical music
Other Names:
  • Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain to be reported via a 10 point visual analog scale (VAS)
Time Frame: Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Time Frame: At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Time Frame: At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Time Frame: At the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
At the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Time Frame: Five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Five minutes post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety to be reported via the State Trait Anxiety Inventory (STAI)
Time Frame: Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure
Anxiety will be reported via the State Trait Anxiety Inventory (STAI), which is scale with a minimum value of 10 (better outcome) and a maximum value of 40 (worse outcome).
Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Study Director: AMY J PATEL, MD, Rutgers, The State University of New Jersey
  • Principal Investigator: Glenmarie Matthews, MD, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2020

Primary Completion (Actual)

May 21, 2021

Study Completion (Actual)

May 21, 2021

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 26, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2020000698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

The data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. To gain access, data requestors should direct proposals to ajp323@rwjms.rutgers.edu.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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