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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

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

Conditions
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Pain, Acute, Anxiety

Intervention / Treatment
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* Behavioral: Preselected classical music


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention being tested is music. Patients will receive either routine pain control measures only (control group) or routine pain control measures and music (treatment group). 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 listen to preselected classical music.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine pain control<br>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<br>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<br>* Preselected classical music<br>* Other names: Music;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain to be reported via a 10 point visual analog scale (VAS) | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine Devices