Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000347561
Ethics application status
Approved
Date submitted
6/12/2023
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of music on perioperative anxiety in patients undergoing caeserean section
Scientific title
Effects of music on perioperative anxiety in patients undergoing caesarean section with regional anesthesia: A randomized prospective controlled study
Secondary ID [1] 310735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 331681 0
Caesarean section 331682 0
Pregnancy 332861 0
Condition category
Condition code
Alternative and Complementary Medicine 328416 328416 0 0
Other alternative and complementary medicine
Anaesthesiology 328432 328432 0 0
Other anaesthesiology
Reproductive Health and Childbirth 329577 329577 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: Listening to music during surgery
Patients listened to the type of music preferred by them during the cesarean section surgery starting from surgical incision to wound dressing was done with an over-ear headset.
The music was selected by opening a playlist in the style the patient desired from a music application. It was confirmed by asking the patients that headphones were playing the music. The sound level that patients felt comfortable with was adjusted. Listening to music was not stopped during the surgery. If music was stopped during surgery, patients were asked to inform this.Patients who refused to listen to music intraoperatively or who had to remove their headphones for any reason were not included in the study.

Arm 2: Isolating patients from ambient operating room noise.
A group of patients wore headphones starting from the surgical incision until wound dressing was done without listening to any music. Headphones were only used to keep the patients away from the operating room noise.

An anaesthesiologist performed all the interventions in the operating room. All surgeries were performed under regional anaesthesia (combined spinal- epidural anaesthesia).
No sedative medication was administered to any patient.
Intervention code [1] 327150 0
Treatment: Other
Comparator / control treatment
The control group underwent surgery under regional anesthesia (combined spinal-epidural anesthesia) without wearing headphones, listening to music, or using any sedative drugs.
Control group
Active

Outcomes
Primary outcome [1] 336319 0
Anxiety
Timepoint [1] 336319 0
Within a month before the surgery, at the Anesthesiology and Reanimation outpatient clinic (It is not a certain date, because patients come to the Anesthesiology and Reanimation outpatient clinic after they have been examined by an obstetrician and decided to cesarean section. This can be either three weeks or one week before the surgery.), on the morning of the day of cesarean section surgery, at the obstetric service where the patients were, at the 1st postoperative hour.

The primary timepoint is the 1st postoperative hour.
Secondary outcome [1] 427837 0
Pain
Timepoint [1] 427837 0
Postoperative 1st, 4th, 8th and 12th hours
Secondary outcome [2] 427838 0
Heart rate (Beat per minute)
Timepoint [2] 427838 0
Assessed continuously during intraoperative period, at the postoperative 1st, 4th, 8th and 12th hours
Secondary outcome [3] 427839 0
Blood Pressure (systolic, diastolic, mean)
Timepoint [3] 427839 0
Assessed continuously during intraoperative period, at he postoperative 1st, 4th, 8th and 12th hours

Eligibility
Key inclusion criteria
Patients undergoing elective caesarean section surgery with American Society of Anaesthesiologists Score II and III
Minimum age
18 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with contraindications for regional anesthesia, hearing impairment or a history of psychiatric drug use, professionally trained in music, foreign nationals and patients refused to wear headphones and/or listen to music to conduct the study were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main goal of the study was to figure out the differences in STAI-SA throughout the follow-up period among groups. A total sample size of 84 was required (28 for each group) to detect at least a 0.40 effect size (a.k.a. Cohen’s F) among groups with a power of 80% at the 1.67‰ significance level in terms of Bonferroni correction. The value of 0.40 was taken from our clinical experiments. Sample size estimation was performed using G*Power (Franz Faul, Universität Kiel, Kiel, Germany) version 3.0.10.

Data analysis was performed using IBM SPSS Statistics version 25.0 software (IBM Corporation, Armonk, NY, US). Kolmogorov-Smirnov test was used to investigate whether the normal distribution assumption was met. Homogeneity of variances was examined Levene test. Categorical data were expressed as numbers (n) and percentage (%) while quantitative data were given as mean ± SD and median (25th - 75th) percentiles. While the mean differences among groups were compared One-Way ANOVA, otherwise the Kruskal Wallis test was applied for the comparisons of the continuous variables which the parametrical test assumptions were not met. When the p-values from One-Way ANOVA were statistically significant, post-hoc Tukey HSD test was used to know which group differ from which others. Categorical data were analyzed Pearson’s 2 or Fisher Freeman Halton test, where appropriate. While the mean differences in HR and, mean blood pressure measures among follow-up time were compared Repeated measures of ANOVA via Wilks’ Lambda test, otherwise the Friedman test was applied for the comparisons of STAI and VAS. When the p-values from Wilks’ Lambda or Friedman test were statistically significant, Bonferroni adjusted multiple comparison or Dunn-Bonferroni test was used to know which follow-up time differ from which others. A p value less than 0.05 was considered statistically significant. However, for all possible multiple comparison, the Bonferroni Correction was applied for controlling Type I error.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/12/2019
Date of last participant enrolment
Anticipated
Actual
26/02/2020
Date of last data collection
Anticipated
Actual
19/03/2020
Sample size
Target
84
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 25897 0
Turkey
State/province [1] 25897 0
Ankara

Funding & Sponsors
Funding source category [1] 314966 0
Self funded/Unfunded
Name [1] 314966 0
Country [1] 314966 0
Primary sponsor type
Individual
Name
Pinar Kirdemir
Address
Ankara Etlik Lady Zübeyde Gynaecology Education and Research Hospital Yeni Etlik Street No: 55 Keçiören Ankara, Turkey 06010
Country
Turkey
Secondary sponsor category [1] 316964 0
Individual
Name [1] 316964 0
Hale Yarkan Uysal
Address [1] 316964 0
Ankara Training and Research Hospital Ulucanlar Street No: 89 Altindag, Ankara, Turkey 06320
Country [1] 316964 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313940 0
Ministry of Health Ankara Training and Research Hospital Clinical Research Ethics Committee
Ethics committee address [1] 313940 0
Ethics committee country [1] 313940 0
Turkey
Date submitted for ethics approval [1] 313940 0
21/10/2019
Approval date [1] 313940 0
05/12/2019
Ethics approval number [1] 313940 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129858 0
Dr Pinar Kirdemir
Address 129858 0
Ankara Etlik Lady Zübeyde Gynaecology Education and Research Hospital Yeni Etlik Street No:55 Etlik Keçiören, Ankara 06010
Country 129858 0
Turkey
Phone 129858 0
+905348226752
Fax 129858 0
Email 129858 0
[email protected]
Contact person for public queries
Name 129859 0
Pinar Kirdemir
Address 129859 0
Ankara Etlik Lady Zübeyde Gynaecology Education and Research Hospital Yeni Etlik Street No:55 Etlik Keçiören, Ankara 06010
Country 129859 0
Turkey
Phone 129859 0
+905348226752
Fax 129859 0
Email 129859 0
[email protected]
Contact person for scientific queries
Name 129860 0
Pinar Kirdemir
Address 129860 0
Ankara Etlik Lady Zübeyde Gynaecology Education and Research Hospital Yeni Etlik Street No:55 Etlik Keçiören, Ankara 06010
Country 129860 0
Turkey
Phone 129860 0
+905348226752
Fax 129860 0
Email 129860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data researched in the study, except the personal information of the patients, will be shared.
When will data be available (start and end dates)?
Data will be available for 5 years from date of registration.
Available to whom?
To all researchers who request to access data
Available for what types of analyses?
Available for data analysis of numerical measurements
How or where can data be obtained?
Data can be accessed by sending an email to the corresponding author of the study. The email adress is "[email protected]"


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21113Ethical approval  [email protected] 386700-(Uploaded-24-03-2024-19-10-46)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.