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

NCT ID: NCT02922504

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-10-31

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.

Conditions

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First Trimester Abortion Surgical Abortion Music Intervention Local Anesthesia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Music intervention group

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

Group Type EXPERIMENTAL

Music intervention group

Intervention Type BEHAVIORAL

Controlled group

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

Group Type ACTIVE_COMPARATOR

Controlled group

Intervention Type BEHAVIORAL

Interventions

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Music intervention group

Intervention Type BEHAVIORAL

Controlled group

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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49RC16_0073

Identifier Type: -

Identifier Source: org_study_id

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