The Effectiveness of Music on Pain and Anxiety in IUD Insertion

Not Applicable

• Conditions: Anxiety Acute; IUD Insertion Complication; Pain, Acute
• Interventions: Behavioral: Music listening

• Registration Number: NCT03828760
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-03-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Listening	Music listening	Patients will receive music of choice to listen to using a music-playing device in the waiting room prior to IUD insertion, as well as during the procedure.

Primary Outcome Measures

Name	Time	Method
Change in self-reported anxiety (in the moment)	Baseline, immediately after the procedure, immediately after uterine sounding	100 mm visual analog scale (VAS) measures anxiety reported by patients; values range 0-100 with higher values representing higher anxiety.

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline, immediately after the procedure	The trait anxiety subscale of the State-Trait Anxiety Inventory (Spielberger et al.,1983) will be used to measure trait anxiety. It contains 20 items, each item is rated on a 4-point scale (not at all, somewhat, moderately so, very much so), with higher values representing higher anxiety. Scores range from 20-80 (higher scores represent higher trait anxiety).
Complications related to IUD insertion procedure	Immediately after the procedure	Patients and providers are asked to identify any significant adverse reactions experienced (by the patient) during the IUD insertion procedure (e.g., bleeding, vasovagal responses) with open-ended survey developed for the study.
Change in self-reported pain (in the moment)	Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure	100 mm visual analog scale (VAS) measures pain reported by patients; values range 0-100 with higher values representing higher pain.

Trial Locations

Locations (1)

McMaster Family Practice; 🇨🇦 Hamilton, Ontario, Canada