Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office

NCT05068245 | Completed

• 1 other identifier: Pro2020000698
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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)

Conditions

Pain, Acute; Anxiety

Keywords

Intrauterine Devices

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  Five minutes post-procedure

Secondary Outcomes (1)

• Anxiety to be reported via the State Trait Anxiety Inventory (STAI)

  Anxiety will be recorded immediately prior to the procedure and five minutes post-procedure

Study Arms (2)

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.

Behavioral: Preselected classical music

Interventions

Preselected classical music BEHAVIORAL

Preselected classical music

Also known as: Music

Routine pain control plus music

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (7)

• 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.

  PMID: 31276848 BACKGROUND

• 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.

  PMID: 29064966 BACKGROUND

• 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.

  PMID: 28885425 BACKGROUND

• 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.

  PMID: 31401254 BACKGROUND

• 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.

  PMID: 22176793 BACKGROUND

• 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.

  PMID: 22240180 BACKGROUND

• 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.

  PMID: 27760797 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• AMY J PATEL, MD

  Rutgers, The State University of New Jersey

  STUDY DIRECTOR

• Glenmarie Matthews, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Planning Specialist

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 5, 2021
• Study Start: August 28, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: The data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. To gain access, data requestors should direct proposals to ajp323@rwjms.rutgers.edu.

Locations

US (2)