Spinal AnesthesiaMusicAnx-SSPINCT05002257
Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
A study testing music therapy and No music therapy in people with Spinal Anesthesia, run by CHU de Reims at 1 site in France.
Trial summary
Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- music therapy and No music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 8 Jul 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients;
- undergoing scheduled orthopedic surgery, under spinal anesthesia;
- non-cancerous, functional;
- in traditional or outpatient hospitalization;
- requiring a passage in PACU;
- agreeing to participate in the study (consent form).
Who cannot join
- Children;
- under tutorship or curatorship;
- having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered
- Patients equipped with their personal music.
- The following will be excluded when they arrive in SSPI:
- Patients who received a benzodiazepine during the intraoperative period;
- Patients whose spinal anesthesia has been converted to general anesthesia;
Trial locations and contacts
1 site in 1 country.
About this study
Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.
Read the detailed description
We want to demonstrate that listening to music:
- decreases the anxiety of patients in PHC;
- improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative…) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.
- Conditions
- Spinal Anesthesia
- Being tested
- music therapy, No music therapy
- Keywords
- PACU, pain, care, music, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
Patients included in the intervention arm with music therapy will choose among 3 possible music: music from elsewhere, classical music, today's music. These 3 music thearpy will have an identical duration of 20 minutes.
No music therapyOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Other: music therapy |
| Control arm | Active comparator | Not described Receives: Other: No music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia
Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start25 May 2021
- Primary completion8 Mar 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002257
- Sponsor's protocol ID
- PP21063
- Acronym
- MusicAnx-SSPI
- Status last verified
- Feb 2025
- First submitted
- 3 Aug 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05002257
- Acronym / sponsor ID
- MusicAnx-SSPI / PP21063
- Conditions
- Spinal Anesthesia
- Keywords
- PACU, pain, care, music, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- 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.
Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.
Detailed description
We want to demonstrate that listening to music:
- decreases the anxiety of patients in PHC;
- improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative…) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: music therapy |
| Control arm | Active comparator | Other: No music therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients;
- undergoing scheduled orthopedic surgery, under spinal anesthesia;
- non-cancerous, functional;
- in traditional or outpatient hospitalization;
- requiring a passage in PACU;
Key exclusion criteria (7 listed)
- Children;
- under tutorship or curatorship;
- having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered
- Patients equipped with their personal music.
- Patients who received a benzodiazepine during the intraoperative period;
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 therapyPatients included in the intervention arm with music therapy will choose among 3 possible music: music from elsewhere, classical music, today's music. These 3 music thearpy will have an identical duration of 20 minutes. | Other | Experimental Arm |
| No music therapyUsual care | Other | Control arm |
Primary outcome
anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia
Time frame: Day 0
Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)
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 5 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy and No music therapy in people with Spinal Anesthesia, run by CHU de Reims at 1 site in France.
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 6 inclusion and 7 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia (time frame: Day 0). 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 5 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.