Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement

NCT04835701 | Terminated

• 1 other identifier: IRB-20-03749
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes. Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale (VAS). This will be administered at 8 points during the procedure. All subjects will also answer the same 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study.

Conditions

Contraception

Keywords

Intrauterine device; IUD; Pain; Music

Outcome Measures

Primary Outcomes (1)

• 100-mm visual analog scale (VAS)

  100-mm VAS total scale from 1-100 with higher score indicating more pain

  Day 1, at time of IUD insertion

Secondary Outcomes (7)

• 100-mm visual analog scale (VAS)

  Day 1, baseline prior to IUD insertion

• 100-mm visual analog scale (VAS)

  Day 1, after speculum placement

• 100-mm visual analog scale (VAS)

  Day 1, on tenaculum application

• 100-mm visual analog scale (VAS)

  Day 1, on uterine sounding

• 100-mm visual analog scale (VAS)

  Day 1, after speculum removal

Study Arms (2)

Music Intervention group

EXPERIMENTAL

Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Participants will otherwise undergo standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes.

Behavioral: Music

Control group

NO INTERVENTION

Participants to undergo same standard protocol for IUD insertion in an outpatient clinic setting. No music will be played during the procedure.

Interventions

Music BEHAVIORAL

Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure.

Music Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 2\. Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation)
• English-speaking patients
• Undergoing insertion of a copper or levonorgestrel intrauterine device
• Willing to comply with all study procedures

You may not qualify if:

• Non-English speaking patients
• Patients with a support person in the room during IUD insertion
• Patients desiring a paracervical block for analgesia

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Neha R Bhardwaj, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics, Gynecology and Reproductive Science

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: December 14, 2020
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)