Recruiting

Music

Sponsor:

McMaster University

Code:

NCT03828760

Conditions

IUD Insertion Complication

Pain, Acute

Anxiety Acute

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Music listening

Study Details

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.

Conditions

IUD Insertion Complication

Pain, Acute

Anxiety Acute

Study ID

NCT03828760

Start date

Mar 12, 2019

Status verified date

Apr, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Change in self-reported anxiety (in the moment) [ Time Frame: Baseline, immediately after the procedure, immediately after uterine sounding ]

Central Contacts and Locations

Central contacts

Robin Lennox, MD

(905) 525 - 9140robin.lennox@medportal.ca

Locations

McMaster Family Practice

Recruiting

Hamilton, Ontario, Canada

More Information

Sponsor

McMaster University

Last update posted

Apr 14, 2022

Last verified

Apr, 2022

Keywords

  • Intrauterine Device
  • IUD
  • Anxiety
  • Pain
  • Music
  • Contraception
  • Visual analog scale
  • VAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-04-14.