Anxiety, Peripheral Nerve Block, Preoperative Anxiety
Conditions
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
Brief summary
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.
Interventions
patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff
patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Sponsors
Study design
Intervention model description
1:1
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in STAI-6 Scores From Post to Pre | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scores of the Experience During Procedure | immediately after nerve block placement (less than 1 minute after) | Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction |
| Provider Satisfaction Scores of the Experience During Procedure | immediately after nerve block placement (less than 1 minute after) | survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction |
| Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider | immediately after nerve block placement (less than 1 minute after) | surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate. |
| Block Times - Time it Took to do the Block | start of doing the block to immediately after nerve block placement, less than 1 minute after | differences amongst music and midazolam group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Music Group self-selected music
Music: patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff | 15 |
| Midazolam Group IV midazolam (1mg to 2mg max)
Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed | 21 |
| Total | 36 |
Baseline characteristics
| Characteristic | Midazolam Group | Total | Music Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 35 Participants | 14 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 18.1 | 42.3 years STANDARD_DEVIATION 18.5 | 42.7 years STANDARD_DEVIATION 19.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 26 Participants | 11 Participants |
| Region of Enrollment United States | 21 participants | 36 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 21 |
| other Total, other adverse events | 0 / 15 | 0 / 21 |
| serious Total, serious adverse events | 0 / 15 | 0 / 21 |
Outcome results
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.
Time frame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Population: Due to lack of resources the study was terminated early and data collection is incomplete.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Group | Change in STAI-6 Scores From Post to Pre | Pre STAI-6 | 34 score on a scale | Standard Deviation 7.02 |
| Music Group | Change in STAI-6 Scores From Post to Pre | Post STAI-6 | 28.19 score on a scale | Standard Deviation 5.17 |
| Midazolam Group | Change in STAI-6 Scores From Post to Pre | Pre STAI-6 | 35.17 score on a scale | Standard Deviation 9.22 |
| Midazolam Group | Change in STAI-6 Scores From Post to Pre | Post STAI-6 | 27.2 score on a scale | Standard Deviation 5 |
Block Times - Time it Took to do the Block
differences amongst music and midazolam group
Time frame: start of doing the block to immediately after nerve block placement, less than 1 minute after
Population: Due to lack of resources the study was terminated early and data collection is incomplete.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Group | Block Times - Time it Took to do the Block | 7 minutes | Standard Deviation 2.03 |
| Midazolam Group | Block Times - Time it Took to do the Block | 7.95 minutes | Standard Deviation 3.26 |
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.
Time frame: immediately after nerve block placement (less than 1 minute after)
Population: Due to lack of resources the study was terminated early and data collection is incomplete.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Music Group | Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider | Patient Perspective | 1 score on a scale |
| Music Group | Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider | Physician Perspective | 1 score on a scale |
| Midazolam Group | Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider | Patient Perspective | 1 score on a scale |
| Midazolam Group | Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider | Physician Perspective | 1 score on a scale |
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
Time frame: immediately after nerve block placement (less than 1 minute after)
Population: Due to lack of resources the study was terminated early and data collection is incomplete.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Music Group | Patient Satisfaction Scores of the Experience During Procedure | 10 units on a scale |
| Midazolam Group | Patient Satisfaction Scores of the Experience During Procedure | 9 units on a scale |
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
Time frame: immediately after nerve block placement (less than 1 minute after)
Population: Due to lack of resources the study was terminated early and data collection is incomplete.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Music Group | Provider Satisfaction Scores of the Experience During Procedure | 10 units on a scale |
| Midazolam Group | Provider Satisfaction Scores of the Experience During Procedure | 10 units on a scale |