The Use of Music for Pain and Anxiety Control During Abortion
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
No Intervention: No music
Participants will not use the digital music player during their procedure.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01013363
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Paula M Castano, MD, MPH||Columbia University|
|Study Director:||Jacqueline M Guerrero, MD||Columbia University|