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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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First Trimester Abortion, Surgical Abortion, Music Intervention, Local Anesthesia, Pain

Intervention / Treatment
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* Behavioral: Music intervention group
* Behavioral: Controlled group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music intervention group<br>For the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure | Behavioral: Music intervention group<br> <br> |
| Active Comparator: Controlled group<br>For the patients in the  controlled  group, the use of analgesic will be use if needed during the procedure | Behavioral: Controlled group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale | evaluation is maide five times | during one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First trimester abortion, Surgical abortion, Music intervention, Local anesthesia, Pain