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The Use of Music for Pain and Anxiety Control During Abortion

NCT01013363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2012-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Paula M Castano, MD, MPH · Columbia University

  • Jacqueline M Guerrero, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01013363 on ClinicalTrials.gov