Clinical trial NCT03828760: The Effectiveness of Music on Pain and Anxiety in IUD Insertion
Official title: Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUD Insertion Complication
Pain, Acute
Anxiety Acute
Keywords: Intrauterine Device
IUD
Anxiety
Pain
Music
Contraception
Visual analog scale
VAS
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Sufficient understanding of English to complete questionnaires
* Women who will attend the clinic for an IUD insertion and accept to participate in the study

Exclusion Criteria:

* Women with chronic pain

Primary outcomes:
measure: Change in self-reported anxiety (in the moment)
timeFrame: Baseline, immediately after the procedure, immediately after uterine sounding
Secondary outcomes:
measure: Change in self-reported pain (in the moment)
timeFrame: Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
measure: Change in anxiety
timeFrame: Baseline, immediately after the procedure
measure: Complications related to IUD insertion procedure
timeFrame: Immediately after the procedure
Other outcomes:
measure: Perceived facilitators and barriers
timeFrame: At study end, approximately 4 months
measure: Provider satisfaction and acceptability
timeFrame: At study end, approximately 4 months
measure: Patient satisfaction and acceptability
timeFrame: Immediately after the procedure
Locations:
city: Hamilton
country: Canada
facility: McMaster Family Practice
state: Ontario
Study officials:
affiliation: McMaster University
name: Robin Lennox, MD
role: PRINCIPAL_INVESTIGATOR
References: