Clinical Trials Directory

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UnknownNCT03828760

The Effectiveness of Music on Pain and Anxiety in IUD Insertion

Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
McMaster University · Academic / Other
Sex
Female
Age
16 Years
Healthy volunteers
Not accepted

Summary

Although intrauterine devices (IUDs) are a highly effective contraceptive method, fear of pain during insertion is one barrier to use. A review of literature reveals little investigation of interventions for anxiety management during the procedure. Furthermore, evidence of non-pharmacological interventions for both anxiety and pain management is limited. Music has been shown to be effective at reducing anxiety and pain in a variety of contexts, however to the investigators' knowledge, its effectiveness for anxiety and pain relief during the IUD insertion procedure has not been formally examined. This study will therefore examine the effectiveness of listening to music on anxiety and pain during IUD insertion.

Detailed description

The study is a randomized controlled trial of patients at least 16 years of age undergoing an IUD insertion. The experimental group will receive music, self-selected, with a music-playing device prior and during the procedure and the control group will receive standard care. Data for pain and anxiety will be collected prior to the procedure, and during, and after IUD insertion. In addition, a post-procedure questionnaire will be given to patients and providers to ask about satisfaction and acceptability of the intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMusic listeningPatients will be asked to either use their personal phones to listen to preferred music which is already on their device, or if they do not have a phone or other personal device capable of playing music of their choice, we will use a device (e.g. iPod) to load music of their choice. While in the waiting room, participants will listen to music through headphones/earphones, however they will need to remove their headphones/earphones during the initial consultation with the family physician (explaining risks, etc.), and resume listening to music through the phone speakers once in the examination room as patients will need to be able to hear instructions from the physician during the procedure.

Timeline

Start date
2019-03-12
Primary completion
2022-12-01
Completion
2022-12-01
First posted
2019-02-04
Last updated
2022-04-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03828760. Inclusion in this directory is not an endorsement.