The Effectiveness of Music on Pain and Anxiety in IUD Insertion

NCT ID: NCT03828760

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2022-12-31

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.

Conditions

IUD Insertion Complication; Pain, Acute; Anxiety Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music listening

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Robin Lennox

Assistant Professor and Family Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Lennox, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Family Practice

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robin Lennox, MD

Role: CONTACT

robin.lennox@medportal.ca

(905) 525 - 9140

Other Identifiers

Tuning Out

Identifier Type: -

Identifier Source: org_study_id