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NCT02922504 Clinical Trial

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

Pain Clinical Trial

— AlgoMusic  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02922504
Other study ID # 49RC16_0073
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date October 2019

Study information
Verified date October 2019
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 159
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Music intervention group

• Controlled group

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Outcome
Type Measure Description Time frame Safety issue
Primary the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale evaluation is maide five times during one day
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