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The Effectiveness of Music on Pain and Anxiety in IUD Insertion

Primary Purpose

IUD Insertion Complication, Pain, Acute, Anxiety Acute

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music listening
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for IUD Insertion Complication focused on measuring Intrauterine Device, IUD, Anxiety, Pain, Music, Contraception, Visual analog scale, VAS

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster Family PracticeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Listening

Standard Care

Arm Description

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.

Patients will receive standard care (excluding the use of music) from providers at the clinic to minimize pain and anxiety during the procedure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 3, 2019
Last Updated
April 12, 2022
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03828760
Brief Title
The Effectiveness of Music on Pain and Anxiety in IUD Insertion
Official Title
Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IUD Insertion Complication, Pain, Acute, Anxiety Acute
Keywords
Intrauterine Device, IUD, Anxiety, Pain, Music, Contraception, Visual analog scale, VAS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators and statisticians performing final data analysis will be blinded to the group allocations
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Listening
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients will receive standard care (excluding the use of music) from providers at the clinic to minimize pain and anxiety during the procedure.
Intervention Type
Behavioral
Intervention Name(s)
Music listening
Intervention Description
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 Information:
Title
Change in self-reported anxiety (in the moment)
Description
100 mm visual analog scale (VAS) measures anxiety reported by patients; values range 0-100 with higher values representing higher anxiety.
Time Frame
Baseline, immediately after the procedure, immediately after uterine sounding
Secondary Outcome Measure Information:
Title
Change in self-reported pain (in the moment)
Description
100 mm visual analog scale (VAS) measures pain reported by patients; values range 0-100 with higher values representing higher pain.
Time Frame
Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
Title
Change in anxiety
Description
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).
Time Frame
Baseline, immediately after the procedure
Title
Complications related to IUD insertion procedure
Description
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.
Time Frame
Immediately after the procedure
Other Pre-specified Outcome Measures:
Title
Perceived facilitators and barriers
Description
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.
Time Frame
At study end, approximately 4 months
Title
Provider satisfaction and acceptability
Description
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.
Time Frame
At study end, approximately 4 months
Title
Patient satisfaction and acceptability
Description
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.
Time Frame
Immediately after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Lennox, MD
Phone
(905) 525 - 9140
Email
robin.lennox@medportal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Lennox, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Family Practice
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effectiveness of Music on Pain and Anxiety in IUD Insertion

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