Pain, AcuteMIUDNCT05068245
Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office
A study testing Preselected classical music in people with Pain, Acute and Anxiety, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Anxiety
- What is being tested?
- Preselected classical music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2020to 21 May 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who have an appointment for IUD insertion at either RWJ or RMG
- Women who are able to read and write in English or Spanish
- Age equal to or greater than 18 years
Who cannot join
- Contraindications to IUD placement: Active pelvic infection, pregnancy, known distortion of uterine cavity, Wilson's disease (Paragard® only), breast cancer (Mirena® only)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard)
Read the detailed description
This will be a randomized control trial conducted in the gynecology clinic inside Robert Wood Johnson University Hospital (RWJ) and the offices of Rutgers Medical Group Obstetrics and Gynecology (RMG). A family planning attending alone at RMG or accompanied by obstetrics and gynecology (Ob/Gyn) residents at RWJ will perform all IUD insertions during this study period. Patients scheduled for an IUD, either the Mirena® (levonorgestrel-releasing intrauterine system 52 mg) or Paragard® (intrauterine copper contraceptive), at both locations will be instructed to take ibuprofen 30 minutes prior to their procedure.
Enrollment will occur during all weekdays at both RWJ and RMG. Eligible women will be enrolled if they are willing to be randomized. Written consent will be obtained from each participant.
After the consent process is completed, the patients will complete a survey which includes their demographic information, if they are currently menstruating, and their pregnancy history while sitting in the waiting room. The patient will also complete a 10 point visual analog scale (VAS) to report her baseline pain and a State Trait Anxiety Inventory (STAI). Vital signs will be recorded with an automated machine.
Participants will then be randomized to routine pain control measures or routine pain control measures plus music. Randomization will be completed by the study staff, who will open sequentially numbered, sealed, opaque envelopes. Allocation will be in a 1:1 ratio. Routine pain control will include instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. It will be noted whether patients actually take ibuprofen or not by the study staff. Patients randomized to receive music in addition to routine pain control measures, will be given a headset that will be plugged into the PI phone to play the preselected classical music. Patients will control the volume. Control group participants also will receive a headset. The headsets will not be noise cancelling.
A study staff member will be present in the room throughout the duration of the procedure in addition to the physician performing the actual insertion of the IUD. This study staff member will complete a procedure information sheet including vitals, type of IUD inserted, and the VAS and STAI at several points of the procedure (immediately prior to the procedure, point of speculum insertion, point of tenaculum placement, point of IUD insertion, and 5 minutes post-procedure).
- Conditions
- Pain, Acute, Anxiety
- Being tested
- Preselected classical music
- Keywords
- Intrauterine Devices
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preselected classical musicBehavioural
Also called Music
Preselected classical music
| Study group | Role | What they receive |
|---|---|---|
| Routine pain control | No intervention | The routine pain control group will receive instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. |
| Routine pain control plus music | Experimental | Patients randomized to receive music in addition to routine pain control measures, will be instructed to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. Preselected classical music will be played for this group throughout the procedure. Receives: Behavioral: Preselected classical music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain to be reported via a 10 point visual analog scale (VAS)
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Measured: Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Measured: At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Measured: At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Measured: At the point of intrauterine device insertion, and five minutes post-procedure
Pain to be reported via a 10 point visual analog scale (VAS)
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Measured: Five minutes post-procedure
Secondary outcomes (1)
Anxiety to be reported via the State Trait Anxiety Inventory (STAI)
Anxiety will be reported via the State Trait Anxiety Inventory (STAI), which is scale with a minimum value of 10 (better outcome) and a maximum value of 40 (worse outcome).
Measured: Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start28 Aug 2020
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention being tested is music. Patients will receive either routine pain control measures only (control group) or routine pain control measures and music (treatment group). Routine pain control will include instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. It will be noted whether patients actually take ibuprofen or not by the study staff. Patients randomized to receive music in addition to routine pain control measures, will listen to preselected classical music.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenmarie Matthews, MD, Rutgers, The State University of New Jersey
- Investigators
- AMY J PATEL, MD, Study director, Rutgers, The State University of New JerseyGlenmarie Matthews, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068245
- Sponsor's protocol ID
- Pro2020000698
- Acronym
- MIUD
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Publications
Abdelhakim AM, Samy A, Abbas AM. Effect of music in reducing patient anxiety during colposcopy: A systematic review and meta-analysis of randomized controlled trials. J Gynecol Obstet Hum Reprod. 2019 Dec;48(10):855-861. doi: 10.1016/j.jogoh.2019.07.007. Epub 2019 Jul 2.
PubMed 31276848Practice Bulletin No. 186 Summary: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):1173-1175. doi: 10.1097/AOG.0000000000002394.
PubMed 29064966Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.
PubMed 28885425Callahan DG, Garabedian LF, Harney KF, DiVasta AD. Will it Hurt? The Intrauterine Device Insertion Experience and Long-Term Acceptability Among Adolescents and Young Women. J Pediatr Adolesc Gynecol. 2019 Dec;32(6):615-621. doi: 10.1016/j.jpag.2019.08.004. Epub 2019 Aug 8.
PubMed 31401254Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15.
PubMed 22176793Guerrero JM, Castano PM, Schmidt EO, Rosario L, Westhoff CL. Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial. Contraception. 2012 Aug;86(2):157-62. doi: 10.1016/j.contraception.2011.11.017. Epub 2012 Jan 10.
PubMed 22240180Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.
PubMed 27760797
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office
- ClinicalTrials.gov ID
- NCT05068245
- Acronym / sponsor ID
- MIUD / Pro2020000698
- Conditions
- Pain, Acute, Anxiety
- Keywords
- Intrauterine Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 5 Oct 2021 (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.
This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard)
Detailed description
This will be a randomized control trial conducted in the gynecology clinic inside Robert Wood Johnson University Hospital (RWJ) and the offices of Rutgers Medical Group Obstetrics and Gynecology (RMG). A family planning attending alone at RMG or accompanied by obstetrics and gynecology (Ob/Gyn) residents at RWJ will perform all IUD insertions during this study period. Patients scheduled for an IUD, either the Mirena® (levonorgestrel-releasing intrauterine system 52 mg) or Paragard® (intrauterine copper contraceptive), at both locations will be instructed to take ibuprofen 30 minutes prior to their procedure.
Enrollment will occur during all weekdays at both RWJ and RMG. Eligible women will be enrolled if they are willing to be randomized. Written consent will be obtained from each participant.
After the consent process is completed, the patients will complete a survey which includes their demographic information, if they are currently menstruating, and their pregnancy history while sitting in the waiting room. The patient will also complete a 10 point visual analog scale (VAS) to report her baseline pain and a State Trait Anxiety Inventory (STAI). Vital signs will be recorded with an automated machine.
Participants will then be randomized to routine pain control measures or routine pain control measures plus music. Randomization will be completed by the study staff, who will open sequentially numbered, sealed, opaque envelopes. Allocation will be in a 1:1 ratio. Routine pain control will include instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. It will be noted whether patients actually take ibuprofen or not by the study staff. Patients randomized to receive music in addition to routine pain control measures, will be given a headset that will be plugged into the PI phone to play the preselected classical music. Patients will control the volume. Control group participants also will receive a headset. The headsets will not be noise cancelling.
A study staff member will be present in the room throughout the duration of the procedure in addition to the physician performing the actual insertion of the IUD. This study staff member will complete a procedure information sheet including vitals, type of IUD inserted, and the VAS and STAI at several points of the procedure (immediately prior to the procedure, point of speculum insertion, point of tenaculum placement, point of IUD insertion, and 5 minutes post-procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention being tested is music. Patients will receive either routine pain control measures only (control group) or routine pain control measures and music (treatment group). Routine pain control will include instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. It will be noted whether patients actually take ibuprofen or not by the study staff. Patients randomized to receive music in addition to routine pain control measures, will listen to preselected classical music.
| Arm | Type | Receives |
|---|---|---|
| Routine pain control | No intervention | –The routine pain control group will receive instructions to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. |
| Routine pain control plus music | Experimental | Behavioral: Preselected classical musicPatients randomized to receive music in addition to routine pain control measures, will be instructed to take ibuprofen 600 mg 30 minutes prior to the procedure. These instructions will be given to all participants. Preselected classical music will be played for this group throughout the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who have an appointment for IUD insertion at either RWJ or RMG
- Women who are able to read and write in English or Spanish
- Age equal to or greater than 18 years
Key exclusion criteria (1 listed)
- Contraindications to IUD placement: Active pelvic infection, pregnancy, known distortion of uterine cavity, Wilson's disease (Paragard® only), breast cancer (Mirena® only)
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 |
|---|---|---|
| Preselected classical musicAlso: MusicPreselected classical music | Behavioural | Routine pain control plus music |
Primary outcome
Pain to be reported via a 10 point visual analog scale (VAS)
Time frame: Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Pain to be reported via a 10 point visual analog scale (VAS)
Time frame: At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Pain to be reported via a 10 point visual analog scale (VAS)
Time frame: At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Pain to be reported via a 10 point visual analog scale (VAS)
Time frame: At the point of intrauterine device insertion, and five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
Pain to be reported via a 10 point visual analog scale (VAS)
Time frame: Five minutes post-procedure
Pain will be reported via a 10 point visual analog scale (VAS), from a score of 0 to 10 with 0 being no pain (better outcome) and 10 being the most pain (worse outcome).
1 secondary outcome
Anxiety to be reported via the State Trait Anxiety Inventory (STAI)
Time frame: Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 31276848Abdelhakim AM, Samy A, Abbas AM. Effect of music in reducing patient anxiety during colposcopy: A systematic review and meta-analysis of randomized controlled trials. J Gynecol Obstet Hum Reprod. 2019 Dec;48(10):855-861. doi: 10.1016/j.jogoh.2019.07.007. Epub 2019 Jul 2.
- Background: PubMed 29064966Practice Bulletin No. 186 Summary: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):1173-1175. doi: 10.1097/AOG.0000000000002394.
- Background: PubMed 28885425Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.
- Background: PubMed 31401254Callahan DG, Garabedian LF, Harney KF, DiVasta AD. Will it Hurt? The Intrauterine Device Insertion Experience and Long-Term Acceptability Among Adolescents and Young Women. J Pediatr Adolesc Gynecol. 2019 Dec;32(6):615-621. doi: 10.1016/j.jpag.2019.08.004. Epub 2019 Aug 8.
- Background: PubMed 22176793Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15.
- Background: PubMed 22240180Guerrero JM, Castano PM, Schmidt EO, Rosario L, Westhoff CL. Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial. Contraception. 2012 Aug;86(2):157-62. doi: 10.1016/j.contraception.2011.11.017. Epub 2012 Jan 10.
- Background: PubMed 27760797Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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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.
AMY J PATEL, MD study director
Rutgers, The State University of New Jersey
Glenmarie Matthews, MD principal investigator
Rutgers, The State University of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preselected classical music in people with Pain, Acute and Anxiety, run by Rutgers, The State University of New Jersey at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain to be reported via a 10 point visual analog scale (VAS) (time frame: Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068245, which also lists 7 linked publications.
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 5 Oct 2021.