Clinical trial NCT05068245: Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office
Official title: Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety
Keywords: Intrauterine Devices
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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)

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to IUD placement: Active pelvic infection, pregnancy, known distortion of uterine cavity, Wilson's disease (Paragard® only), breast cancer (Mirena® only)

Primary outcomes:
measure: Pain to be reported via a 10 point visual analog scale (VAS)
timeFrame: 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
measure: Pain to be reported via a 10 point visual analog scale (VAS)
timeFrame: At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
measure: Pain to be reported via a 10 point visual analog scale (VAS)
timeFrame: At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure
measure: Pain to be reported via a 10 point visual analog scale (VAS)
timeFrame: At the point of intrauterine device insertion, and five minutes post-procedure
measure: Pain to be reported via a 10 point visual analog scale (VAS)
timeFrame: Five minutes post-procedure
Secondary outcomes:
measure: Anxiety to be reported via the State Trait Anxiety Inventory (STAI)
timeFrame: Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: AMY J PATEL, MD
role: STUDY_DIRECTOR
affiliation: Rutgers, The State University of New Jersey
name: Glenmarie Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Practice 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.
citation: Akers 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.
citation: Callahan 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.
citation: Chor 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.
citation: Guerrero 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.
citation: Lee 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.