Music for Anxiety Management in Cesarean Delivery

July 11, 2024 updated by: Tuğba Dündar, Aydin Adnan Menderes University

Management of Anxiety and Vital Signs With Music in Cesarean Delivery: A Randomized Controlled Trial

A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aydın, Turkey
        • Adnan Menderes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Aged between 18-35 years,

  • Undergoing cesarean section under spinal anesthesia,
  • Experiencing spontaneous and singleton pregnancy,
  • With a gestational age greater than 37 weeks,
  • Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,
  • Scheduled for cesarean section (regardless of the number of previous cesarean sections).

Exclusion Criteria:

  • Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Listen to music group
The study group will be played music during the cesarean section.
Other: Listen to music
Women in the intervention groups will listen to nature and bird sounds through over-the-ear headphones after spinal anesthesia for cesarean section until the suturing is completed.
No Intervention: Standart cesarean procedure
The control group continued to receive the routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiete level
Time Frame: 37th gestational weeks]
State-Trait Anxiety Inventory: It can be applied to individuals over the age of 14. It consists of 20 items that determine how an individual feels at a certain moment and under certain conditions. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person filling out the inventory.
37th gestational weeks]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Study Chair: Tuğba Dündar, AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Interventional trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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