The Effectiveness of Music on Pain and Anxiety in IUD Insertion

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828760
• Other study ID #: Tuning Out
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: Robin Lennox, MD
• Phone: (905) 525 - 9140
• Email: robin.lennox[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety Acute
• Anxiety Disorders
• IUD Insertion Complication
• Pain, Acute

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Family Practice	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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