NCT02922504

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

September 27, 2016

Last Update Submit

October 18, 2019

Conditions

First Trimester AbortionSurgical AbortionMusic InterventionLocal AnesthesiaPain

Keywords

First trimester abortionSurgical abortionMusic interventionLocal anesthesiaPain

Outcome Measures

Primary Outcomes (1)

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

    evaluation is maide five times

    during one day

Study Arms (2)

Music intervention group

EXPERIMENTAL

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

Controlled group

ACTIVE COMPARATOR

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

Behavioral: Controlled group

Interventions

Music intervention groupBEHAVIORAL
Music intervention group
Controlled groupBEHAVIORAL
Controlled group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 4, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10