Anxiety Clinical Trial
Official title:
Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia
Verified date | October 2017 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effect of perioperative music on maternal anxiety,
hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and
overall maternal satisfaction.
Investigators hypothesize that women exposed to perioperative music will have greater overall
satisfaction with the delivery experience. Investigators also hypothesize that perioperative
music will lower anxiety levels of women having a scheduled cesarean delivery, result in a
less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in
a lower requirement of analgesics postpartum.
Status | Completed |
Enrollment | 150 |
Est. completion date | October 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - pregnant women - 8 years or older - scheduled for elective cesarean delivery under spinal anesthesia. Exclusion Criteria: - absolute contraindications of neuraxial anesthesia including patient refusal - uncorrected coagulopathy - infection at the skin site of epidural placement - increased intracranial pressure, or untreated hemodynamic instability. - Patients in active labor, with impaired hearing, or who do not want to participate in the study will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maternal anxiety level, VAS | assessed by VAS questionnaire | prior to surgery | |
Primary | maternal anxiety level, VAS | assessed by VAS questionnaire | 30 minutes after surgery | |
Secondary | Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure | nadir systolic arterial pressure within 30 minutes of spinal placement | within 30 minutes of spinal placement | |
Secondary | maternal anxiety level, STAI | assessed by STAI questionnaire | prior to surgery | |
Secondary | maternal anxiety level, STAI | assessed by STAI questionnaire | 30 minutes after surgery | |
Secondary | Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | prior to surgery | |
Secondary | Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | 30 minutes after surgery | |
Secondary | Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | postoperative day 1 | |
Secondary | Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | prior to surgery | |
Secondary | Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | 30 minutes after surgery | |
Secondary | Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | postoperative day 1 | |
Secondary | Vasopressor requirement, phenylephrine | utilization of phenylephrine, micrograms | within 30 minutes of spinal placement | |
Secondary | Vasopressor requirement, ephedrine | utilization of ephedrine, milligrams | within 30 minutes of spinal placement |
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