The Effectiveness of Music on Pain and Anxiety in IUD Insertion

• ClinicalTrials.gov Identifier: NCT03828760
• Recruitment Status: Recruiting
• First Posted: February 4, 2019
• Last Update Posted: March 3, 2021
• Sponsor: McMaster University
• Information provided by (Responsible Party): Robin Lennox, McMaster University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
IUD Insertion Complication; Pain, Acute; Anxiety Acute	Behavioral: Music listening	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The investigators and statisticians performing final data analysis will be blinded to the group allocations
• Primary Purpose: Supportive Care
• Official Title: Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
• Actual Study Start Date: March 12, 2019
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: February 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Perceived facilitators and barriers [ Time Frame: At study end, approximately 4 months ]
   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.
2. Provider satisfaction and acceptability [ Time Frame: At study end, approximately 4 months ]
   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.
3. Patient satisfaction and acceptability [ Time Frame: Immediately after the procedure ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Robin Lennox, MD; (905) 525 - 9140; robin.lennox@medportal.ca

Locations

Canada, Ontario

McMaster Family Practice; Recruiting

Hamilton, Ontario, Canada

Sponsors and Collaborators

McMaster University

Investigators

• Principal Investigator: Robin Lennox, MD; McMaster University

More Information

• Responsible Party: Robin Lennox, Assistant Professor and Family Physician, McMaster University
• ClinicalTrials.gov Identifier: NCT03828760
• Other Study ID Numbers: Tuning Out
• First Posted: February 4, 2019
• Last Update Posted: March 3, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robin Lennox, McMaster University:

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

Additional relevant MeSH terms:

Acute Pain; Anxiety Disorders; Mental Disorders; Pain; Neurologic Manifestations