The Use of Music for Pain and Anxiety Control During Abortion

NCT01013363 | Completed

• 1 other identifier: AAAE0439
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Most first trimester abortions are performed under local anesthesia using either manual or electric vacuum suction aspiration. The majority of women undergoing these procedures experience some amount of pain and anxiety. The investigators seek to understand if the provision of music during first trimester abortion will reduce pain and anxiety associated with this procedure. This study will involve the use of music during first trimester abortion as an additional method of pain and anxiety control. The investigators will recruit women seeking a first trimester suction aspiration procedure primarily for elective pregnancy termination or for other related indications such as an abnormal pregnancy, inevitable abortion, or retained products of conception. Participation will be voluntary and include informed consent. Recruited women will be divided into two groups: control group (no music) and intervention (music) group. All subjects will receive routine care and standard pain control measures, including local anesthesia, during their procedure. Those assigned to the intervention group will receive a portable digital music player (iPOD™ Nano) with headphones to listen to during their procedure. All subjects will complete preoperative and postoperative pain and anxiety questionnaires in addition to a patient satisfaction survey at the end of their visit. The provider will also assess and record the subject's pain experienced during the procedure. The investigators will also measure preoperative and postoperative vital signs on all participants. Subjects will be compensated for their time and study participation will not affect any care received at the clinic. Upon completion of their visit, there will be no additional followup for this study.

Conditions

Pain; Anxiety

Keywords

abortion; first trimester; suction aspiration; vacuum aspiration; music; anesthesia; analgesia; anxiolytic; pain; anxiety; blood pressure; heart rate; satisfaction

Outcome Measures

Primary Outcomes (1)

• Pain and anxiety experienced during first trimester abortion.

  1 day. Outcome measured immediately after procedure without additional follow-up.

Secondary Outcomes (3)

• Heart rate and blood pressure changes.

  Measured before and after procedure.

• Overall patient satisfaction.

  Assessed immediately after procedure.

• Provider assessment of patient's pain.

  Assessed immediately after procedure.

Study Arms (2)

No music

NO INTERVENTION

Participants will not use the digital music player during their procedure.

Music

EXPERIMENTAL

Participants will use the digital music player during their procedure.

Other: iPod Nano digital music player

Interventions

iPod Nano digital music player OTHER

Digital music player pre-loaded with 10 playlists to be used intra-operatively by the participant randomized to the intervention group.

Music

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Viable or non-viable intrauterine pregnancy less than or equal to 14 weeks gestational age (including women with an abnormal pregnancy, inevitable abortion, or retained products of conception)
• Ability to read and speak English or Spanish
• Willingness to participate in the randomized trial

You may not qualify if:

• Hearing or visual impairment
• Allergy to ibuprofen or lidocaine

Sponsors & Collaborators

• Columbia University: lead
• Family Planning Fellowship: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (2)

• 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 RESULT

• Oviedo JD, Ohly NT, Guerrero JM, Castano PM. Factors associated with participant and provider pain rating during office-based first-trimester vacuum aspiration. Contraception. 2018 Jun;97(6):497-499. doi: 10.1016/j.contraception.2018.01.001. Epub 2018 Jan 6.

  PMID: 29317229 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Agnosia; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Study Officials

• Paula M Castano, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Jacqueline M Guerrero, MD

  Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 13, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

US (1)