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Clinical Trial Summary

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)


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05068245
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Completed
Phase N/A
Start date August 28, 2020
Completion date May 21, 2021

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