Peripheral Nerve BlockPhase 1/2NCT05610969
Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks
A Phase 1/2 study testing Music and Midazolam in people with Peripheral Nerve Block and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Block, Anxiety, Preoperative Anxiety
- What is being tested?
- Music and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 8 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who are >18 years of age
- Patients able to give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control
Who cannot join
- significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder
- individuals who were incompetent to give informed consent
- pregnant and/or breast-feeding patients
- any underlying coagulopathy
- infection or other factors which would be a contraindication to receiving a peripheral nerve block
- hypersensitivity to midazolam
- history of renal impairment.
- Patients who were extremely anxious (scores greater than 50 on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.
Read the detailed description
Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.
Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.
Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.
- Conditions
- Peripheral Nerve Block, Anxiety, Preoperative Anxiety
- Being tested
- Music, Midazolam
- Keywords
- Midazolam, Adjuvants, Anesthesia, Anti-Anxiety Agents, Hypnotics and Sedatives, Tranquilizing Agents, Anesthetics, GABA Modulators, GABA Agents, Central Nervous System Depressants, Physiological Effects of Drugs, Neurotransmitter Agents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff
MidazolamDrug
Also called Hypnovel, Versed
patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
| Study group | Role | What they receive |
|---|---|---|
| Music group | Active comparator | self-selected music Receives: Other: Music |
| Midazolam group | Active comparator | IV midazolam (1mg to 2mg max) Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in STAI-6 Scores From Post to Pre
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Measured: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Secondary outcomes (4)
Patient Satisfaction Scores of the Experience During Procedure
Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Measured: immediately after nerve block placement (less than 1 minute after)
Provider Satisfaction Scores of the Experience During Procedure
survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Measured: immediately after nerve block placement (less than 1 minute after)
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.
Measured: immediately after nerve block placement (less than 1 minute after)
Block Times - Time it Took to do the Block
differences amongst music and midazolam group
Measured: start of doing the block to immediately after nerve block placement, less than 1 minute after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Sep 2021
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: terminated due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veena Graff, University of Pennsylvania
- Investigators
- Veena Graff, MD, MS, Principal investigator, University of Pennsylvania, Anesthesiology and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610969
- Sponsor's protocol ID
- 842519
- Status last verified
- May 2025
- First submitted
- 5 Aug 2022
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks
- ClinicalTrials.gov ID
- NCT05610969
- Acronym / sponsor ID
- 842519
- Conditions
- Peripheral Nerve Block, Anxiety, Preoperative Anxiety
- Keywords
- Midazolam, Adjuvants, Anesthesia, Anti-Anxiety Agents, Hypnotics and Sedatives, Tranquilizing Agents, Anesthetics, GABA Modulators, GABA Agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to lack of resources
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.
Detailed description
Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.
Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.
Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Music group | Active comparator | Other: Musicself-selected music |
| Midazolam group | Active comparator | Drug: MidazolamIV midazolam (1mg to 2mg max) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are >18 years of age
- Patients able to give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control
Key exclusion criteria (8 listed)
- significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder
- individuals who were incompetent to give informed consent
- pregnant and/or breast-feeding patients
- any underlying coagulopathy
- infection or other factors which would be a contraindication to receiving a peripheral nerve block
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 |
|---|---|---|
| Musicpatients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff | Other | Music group |
| MidazolamAlso: Hypnovel, Versedpatients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed | Drug | Midazolam group |
Primary outcome
Change in STAI-6 Scores From Post to Pre
Time frame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
4 secondary outcomes
Patient Satisfaction Scores of the Experience During Procedure
Time frame: immediately after nerve block placement (less than 1 minute after)
Provider Satisfaction Scores of the Experience During Procedure
Time frame: immediately after nerve block placement (less than 1 minute after)
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Time frame: immediately after nerve block placement (less than 1 minute after)
Block Times - Time it Took to do the Block
Time frame: start of doing the block to immediately after nerve block placement, less than 1 minute after
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peripheral Nerve Block
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Nerve Block Resolution Time Display and Pain Complaints
Postoperative Pain, Rebound Pain
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.
Veena Graff, MD, MS principal investigator
University of Pennsylvania, Anesthesiology and Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Music and Midazolam in people with Peripheral Nerve Block and Anxiety, run by University of Pennsylvania at 1 site in United States.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 May 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in STAI-6 Scores From Post to Pre (time frame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)). 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 14 May 2025.