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

October 18, 2019 updated by: University Hospital, Angers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale
Time Frame: during one day
evaluation is maide five times
during one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC16_0073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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