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The Use of Music for Pain and Anxiety Control During Abortion

This study has been completed.
Sponsor:
Collaborator:
Family Planning Fellowship
Information provided by (Responsible Party):
Paula Castano, Columbia University
ClinicalTrials.gov Identifier:
NCT01013363
First received: November 6, 2009
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Pain
Anxiety
Other: iPod Nano digital music player

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Music as an Auxiliary Analgesic and Anxiolytic During First Trimester Abortion

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pain and anxiety experienced during first trimester abortion. [ Time Frame: 1 day. Outcome measured immediately after procedure without additional follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate and blood pressure changes. [ Time Frame: Measured before and after procedure. ] [ Designated as safety issue: No ]
  • Overall patient satisfaction. [ Time Frame: Assessed immediately after procedure. ] [ Designated as safety issue: No ]
  • Provider assessment of patient's pain. [ Time Frame: Assessed immediately after procedure. ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No music
Participants will not use the digital music player during their procedure.
Experimental: Music
Participants will use the digital music player during their procedure.
Other: iPod Nano digital music player
Digital music player pre-loaded with 10 playlists to be used intra-operatively by the participant randomized to the intervention group.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Hearing or visual impairment
  • Allergy to ibuprofen or lidocaine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013363

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Family Planning Fellowship
Investigators
Principal Investigator: Paula M Castano, MD, MPH Columbia University
Study Director: Jacqueline M Guerrero, MD Columbia University
  More Information

Publications:
Responsible Party: Paula Castano, Assistant Clinical Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01013363     History of Changes
Other Study ID Numbers: AAAE0439
Study First Received: November 6, 2009
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
abortion
first trimester
suction aspiration
vacuum aspiration
music
anesthesia
analgesia
anxiolytic
pain
anxiety
blood pressure
heart rate
satisfaction

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2014