The Use of Music for Pain and Anxiety Control During Abortion
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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 |
- 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 ]
| 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 |
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| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| 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 Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013