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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; IUD Insertion Complication; Anxiety Acute
• Intervention / Treatment: Behavioral: Music listening

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin Lennox, MD; Phone Number: (905) 525 - 9140; Email: robin.lennox@medportal.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • McMaster Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Music listening; Patients 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.
NO_INTERVENTION: Standard Care; Patients will receive standard care (excluding the use of music) from providers at the clinic to minimize pain and anxiety during the procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported pain (in the moment)	100 mm visual analog scale (VAS) measures pain reported by patients; values range 0-100 with higher values representing higher pain.	Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
Change in anxiety	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).	Baseline, immediately after the procedure
Complications related to IUD insertion 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.	Immediately after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived facilitators and barriers	Open-ended questionnaire developed for the study asking the provider whether there are any methods to help implement listening to music during the IUD insertion procedure.	At study end, approximately 4 months
Provider satisfaction and acceptability	Open-ended questionnaire developed for the study asking provider about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to patients.	At study end, approximately 4 months
Patient satisfaction and acceptability	Open-ended questionnaire developed for the study asking patient about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to friends.	Immediately after the procedure

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Robin Lennox, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (ACTUAL): February 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Contraception; VAS; Intrauterine Device; Music; IUD; Visual analog scale
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Acute Pain
• Other Study ID Numbers: Tuning Out

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No