The Effectiveness of Music on Pain and Anxiety in IUD Insertion

NCT03828760 | Unknown

• 1 other identifier: Tuning Out
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in self-reported pain (in the moment)

  Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure

• Change in anxiety

  Baseline, immediately after the procedure

• Complications related to IUD insertion procedure

  Immediately after the procedure

Other Outcomes (3)

• Perceived facilitators and barriers

  At study end, approximately 4 months

• Provider satisfaction and acceptability

  At study end, approximately 4 months

• Patient satisfaction and acceptability

  Immediately after the procedure

Study Arms (2)

Music Listening

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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 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.

Music Listening

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient understanding of English to complete questionnaires
• Women who will attend the clinic for an IUD insertion and accept to participate in the study

You may not qualify if:

• Women with chronic pain

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Family Practice

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Robin Lennox, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Lennox, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and statisticians performing final data analysis will be blinded to the group allocations
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Family Physician

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: February 4, 2019
• Study Start: March 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CA (1)