IUD Insertion ComplicationNCT03828760
The Effectiveness of Music on Pain and Anxiety in IUD Insertion
A study testing Music listening in people with IUD Insertion Complication and Pain, Acute, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- IUD Insertion Complication, Pain, Acute, Anxiety Acute
- What is being tested?
- Music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sufficient understanding of English to complete questionnaires
- Women who will attend the clinic for an IUD insertion and accept to participate in the study
Who cannot join
- Women with chronic pain
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster Family Practice
Hamilton, Ontario
About this study
Official title: Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
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.
Read the 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
- Being tested
- Music listening
- Keywords
- Intrauterine Device, IUD, Anxiety, Pain, Music, Contraception, Visual analog scale, VAS
- Medical subject headings
- Acute Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the procedure, immediately after uterine sounding
Secondary outcomes (3)
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.
Measured: Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
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).
Measured: Baseline, immediately after the procedure
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.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start12 Mar 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion ComplicationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Lennox, McMaster University
- Investigators
- Robin Lennox, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828760
- Sponsor's protocol ID
- Tuning Out
- Status last verified
- Apr 2022
- First submitted
- 3 Jan 2019
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT03828760
- Acronym / sponsor ID
- Tuning Out
- Conditions
- IUD Insertion Complication, Pain, Acute, Anxiety Acute
- Keywords
- Intrauterine Device, IUD, Anxiety, Pain, Music, Contraception, Visual analog scale, VAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Listening | Experimental | Behavioral: Music listeningPatients 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. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sufficient understanding of English to complete questionnaires
- Women who will attend the clinic for an IUD insertion and accept to participate in the study
Key exclusion criteria (1 listed)
- Women with chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listeningPatients 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. | Behavioural | Music Listening |
Primary outcome
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.
3 secondary outcomes
Change in self-reported pain (in the moment)
Time frame: Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
Change in anxiety
Time frame: Baseline, immediately after the procedure
Complications related to IUD insertion procedure
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Lennox, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with IUD Insertion Complication and Pain, Acute, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Lennox, MD ((905) 525 - 9140, robin.lennox@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported anxiety (in the moment) (time frame: Baseline, immediately after the procedure, immediately after uterine sounding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.