2. METHODS
Study Design: The research was conducted in accordance with the
CONSORT guidelines between January 2021 and March 2021 as a
single-center, controlled, randomized study.
Ethics, Consent, and Permissions: Ethical permission for the
study was obtained from the NE University Ethical Committee (No. 2957,
December 18, 2020).
Inclusion Criteria: Patients over 18 years of age with
singleton term pregnancies (over 37 weeks) undergoing elective cesarean
section (obstetric indications or patients with previous cesarean
section) under regional anesthesia were included in the study.
Exclusion Criteria: Pregnant women with maternal hypertensive
disorders (chronic hypertension or preeclampsia), insulin-dependent
diabetes mellitus, intrauterine growth retardation, pregnancies at the
41st week, premature rupture of membranes, multiple pregnancies, in
utero fetal death, known fetal anomalies, hearing impairment, or
psychiatric disorders were excluded from the study.
Participants: Potential participating patients were enrolled in
the study after being informed by a single researcher (JEH) about the
purpose of the study and how data would be collected. Eligible
participants were told that they would participate in a pain relief
study during the operation. They were not informed about the role of
music in order to conduct a single-blind test. After obtaining informed
consent in writing and verbally, the following data were collected from
all participants before the procedure: age, parity, previous cesarean
section information, smoking history, and illnesses. Participants were
randomized into an intervention group that would listen to music and a
control group that would not listen to music. Randomization was done by
the researchers using the coin-flip method, where tails represented the
music group and heads represented the control group. Of the 60 pregnant
women initially included in the study, five were excluded from the study
because they were switched to general anesthesia during the operation,
three decided not to participate in the study, and three did not
complete the questionnaire completely (Figure 1).