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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922504
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02922504    
Other Study ID Numbers: 49RC16_0073
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Keywords provided by University Hospital, Angers:
First trimester abortion
Surgical abortion
Music intervention
Local anesthesia
Pain
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs