Impact of Music Intervention on Pain Control In First Tri... | NCT02922504

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

NCT02922504

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Oct 22, 2019Actual

Enrollment

159Actual

Phase

Not Applicable

Conditions

First Trimester Abortion
Surgical Abortion
Music Intervention
Local Anesthesia
Pain

Interventions

Music intervention group
Controlled group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2019Actual

Completion Date

Oct 2019Actual

First Submitted Date

Sep 27, 2016

First Submission Date that Met QC Criteria

Sep 30, 2016

First Posted Date

Oct 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 22, 2019Actual

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Music intervention group	Behavioral		Music intervention group
Controlled group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided