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Music in surgeries

Benefit of intraoperative Music in Orthopedic Surgeries under Spinal Anesthesia: a Randomized Clinical Trial - : Benefit of intraoperative music in orthopedic surgeries under spinal anesthesia: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4vsvy6
Enrollment
Unknown
Registered
2018-09-26
Start date
2017-02-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, surgery, lower members, pain

Interventions

The patients of the study will be approached in a serial way, during the preanesthetic visit performed in the Anesthesia Outpatient Clinic, before the surgical procedure. The date of the preanesthetic
B patient who will receive phone with music. Headphones are circumaural or "around ear" type. The patient will have the opportunity to see him in the pre-anesthetic consultation. They are best suited
Device
Behavioural
E02.190.888.500

Sponsors

Faculdade de Tecnologia e Ciências
Lead Sponsor
Hospital Manoel Victorino
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Will be included all patients with age between 18 and 65 years, submitted to surgery of lower members, with spinal anesthesia; physical condition P1 (patients without comorbidities) or P2 (patients with comorbidities with control, for example, systemic arterial hypertension on medication and normal blood pressure values.

Exclusion criteria

Exclusion criteria: Patients in use or previous use (up to one year) of antidepressants or anxiolytics will be excluded; patients diagnosed with psychiatric illness using or not drug therapy; illicit drug users; patients who are unable to respond to the survey satisfactorily and those who refuse to participate in the survey. Also excluded is the patient who has already participated in the study and is undergoing a new surgical procedure and those whose surgery lasts less than one hour, in addition to cases in which there is partial or total failure of spinal anesthesia, due to the greater use of complementary sedation .

Design outcomes

Primary

MeasureTime frame
Anxiety reduction in Group 2 patients, measured by the Spielberger Trait-State Anxiety Inventory (IDATE). It is expected to find a results comparable with the number found in a previous meta-analysis that showed an anxiety reduction in 69%. For intergroup comparison the t-Test will be used for unpaired samples. To compare the differences within the same group, we will use the analysis of variance for continuous variables with symmetric distribution (A-NOVA), with Newman-Keuls post-test for multiple comparisons. The critical level of significance will be 5%.

Secondary

MeasureTime frame
Decreased use of sedative and analgesic drugs in patients in group 2. Sedation dose will be uniform for all patients enrolled in the study. Additional doses required by patients will be recorded to verify sedation needs comparison intergroups.

Countries

Brazil

Contacts

Public ContactMatheus Melo Viana

Faculdade de Tecnologia e Ciências

matheusmviana@hotmail.com+5577991912281

Outcome results

None listed

Source: REBEC (via WHO ICTRP)