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

Primary Purpose

First Trimester Abortion, Surgical Abortion, Music Intervention

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Music intervention group

Controlled group

About this trial

This is an interventional prevention trial for First Trimester Abortion focused on measuring First trimester abortion, Surgical abortion, Music intervention, Local anesthesia, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music intervention group

Controlled group

Arm Description

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

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

Outcomes

Primary Outcome Measures

the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale

evaluation is maide five times

Secondary Outcome Measures

Full Information

NCT ID

NCT02922504

First Posted

September 27, 2016

Last Updated

October 18, 2019

Sponsor

University Hospital, Angers

1. Study Identification

Unique Protocol Identification Number

NCT02922504

Brief Title

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

Acronym

AlgoMusic

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Angers

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

First trimester abortion, Surgical abortion, Music intervention, Local anesthesia, Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Music intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Controlled group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Music intervention group

Intervention Type

Behavioral

Intervention Name(s)

Controlled group

Primary Outcome Measure Information:

Title

the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale

Description

evaluation is maide five times

Time Frame

during one day

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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

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