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

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT02922504

Collaborator

(none)

159

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
First Trimester Abortion Surgical Abortion Music Intervention Local Anesthesia Pain	Behavioral: Music intervention group Behavioral: Controlled group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music intervention group 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
Active Comparator: Controlled group For the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure	Behavioral: Controlled group

Arm

Intervention/Treatment

Experimental: Music intervention group

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

Active Comparator: Controlled group

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

Behavioral: Controlled group

Outcome Measures

Primary Outcome Measures

the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale [during one day]
evaluation is maide five times

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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