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NCT04835701 · ClinicalTrials.gov registry record · NA
Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT04835701: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04835701 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04835701, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes. Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale (VAS). This will be administered at 8 points during the procedure. All subjects will also answer the same 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study.
Primary Outcome
100-mm VAS total scale from 1-100 with higher score indicating more pain
Interventions
- BEHAVIORAL Music
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2021-11-16 |
| Phase | NA |
Why NCT04835701 stopped before completion
NCT04835701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Music is the first listed.
NCT04835701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04835701 about?
NCT04835701 is a clinical study titled "Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement". The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Musi...
What is the current status of trial NCT04835701?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2020-12-14. Estimated completion is 2021-11-16.
What interventions are being tested in trial NCT04835701?
The interventions under investigation include: Music (BEHAVIORAL).
Who is sponsoring clinical trial NCT04835701?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04835701's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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