Music for Anxiety Management in Cesarean Delivery

NCT06496932 | Completed

• 1 other identifier: Interventional trial
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy

Keywords

cesarean section; music; randomize trial

Outcome Measures

Primary Outcomes (1)

• anxiete level

  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]

Study Arms (2)

Listen to music group

EXPERIMENTAL

The study group will be played music during the cesarean section.

Other: Listen to music

Standart cesarean procedure

NO INTERVENTION

The control group continued to receive the routine care

Interventions

Listen to music OTHER

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.

Listen to music group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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).

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University

Aydin, Turkey (Türkiye)

Location

Study Officials

• Tuğba Dündar

  AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: September 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)