The Use of Music for Pain and Anxiety Control During Abortion
Completed · Not applicable
Conditions studied: Pain, Anxiety
In brief
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.
Key facts
- Study ID
- NCT01013363
- Run by
- Columbia University
- People needed
- 106
- Starts
- 2009-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2012-11-19
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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