First Trimester AbortionAlgoMusicNCT02922504
Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
A study testing Music intervention group in people with First Trimester Abortion and Surgical Abortion, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- First Trimester Abortion, Surgical Abortion, Music Intervention
- What is being tested?
- Music intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Music intervention group, Controlled group
- Keywords
- First trimester abortion, Surgical abortion, Music intervention, Local anesthesia, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music intervention groupBehavioural
Controlled groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Controlled group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale
evaluation is maide five times
Measured: during one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Trimester AbortionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922504
- Sponsor's protocol ID
- 49RC16_0073
- Acronym
- AlgoMusic
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT02922504
- Acronym / sponsor ID
- AlgoMusic / 49RC16_0073
- Keywords
- First trimester abortion, Surgical abortion, Music intervention, Local anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention group | Experimental | Behavioral: Music intervention groupFor the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure |
| Controlled group | Active comparator | Behavioral: Controlled groupFor the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music intervention group | Behavioural | Music intervention group |
| Controlled group | Behavioural | Controlled group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention group in people with First Trimester Abortion and Surgical Abortion, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale (time frame: during one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.