Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia

NCT02922504 — Not applicable, Completed, 159 participants, University Hospital, Angers

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RegistryNCT02922504, acronym AlgoMusic
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment159 (Actual)
SponsorUniversity Hospital, Angers (Other gov)
ConditionsFirst Trimester Abortion, Surgical Abortion, Music Intervention, Local Anesthesia, Pain
InterventionsMusic intervention group, Controlled group (Behavioral)
Datesstart 2016-10-01, primary completion 2019-10-01, completion 2019-10-01, first posted 2016-10-04, last updated 2019-10-22

Related Papers Related Patents Related Grants Related Experts
All trials for First Trimester Abortion All trials for Surgical Abortion All trials of Music intervention group All trials of Controlled group

-Summary

A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant , the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatement instead of a standard care for an abortion.

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+Detailed description

A surgical abortion under local anesthesiac is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant, the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatment instead of a standard care for an abortion.

The number of patients needed is estimate to be eighty patients per group.

The result of the study could allow :

* Showing the effectiveness of music intervention before operative abortion as adjuvant treatment on the pain, anxiety and nausea during a surgical abortion by suction aspiration under local anesthesia.
* Improving the experience of an abortion and the satisfaction of the patients as well as lowering the use of drugs.

+Arms and interventions

ArmTypeInterventionsDescription
Music intervention groupExperimentalBehavioral: Music intervention groupFor the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure
Controlled groupActive comparatorBehavioral: Controlled groupFor the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure
  • Music intervention group (Behavioral)
  • Controlled group (Behavioral)

+Outcome measures

Primary outcomes

  • the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale [during one day]: evaluation is maide five times

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Every patients must have more than 18 years old
* Hospitalised at the Angers Hospital for a surgical abortion under local anesthesia.
* Affiliated or be part of the french Sécurité Sociale ( health service )
* To have signed a consent form

Exclusion Criteria:

* Patients not speaking french
* People who should not use music intervention ( Total or partial hearing difficulties)
* No consent given
* Adults protected by the law
* Not being part of another medical study