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

University Hospital, Angers

Status: Completed

Conditions: Surgical Abortion; First Trimester Abortion; Local Anesthesia; Music Intervention; Pain

Treatments: Behavioral: Controlled group; Behavioral: Music intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT02922504

49RC16_0073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 2 patient groups

Music intervention group

Experimental group

Description:

For the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure

Treatment:

Behavioral: Music intervention group

Controlled group

Active Comparator group

Description:

For the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure

Treatment:

Behavioral: Controlled group