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Effect of Music on Anxiety Levels During Intrauterine Device Application

NCT07038187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-26

No results posted yet for this study

Summary

This study was conducted as a pre-test/post-test, randomized controlled trial to evaluate the effect of music on anxiety levels of women undergoing intrauterine device (IUD) insertion. Data were collected between January 2025 and May 2025 at a Community Health Center in Bingöl province. A total of 60 women (30 in the experimental group, 30 in the control group) who applied for IUD insertion were included. Women in the experimental group listened to slow classical music (12-15 beats per minute) through headphones for approximately 20 minutes prior to the procedure and continued listening during the procedure, totaling 30 minutes. Women in the control group did not listen to music. Anxiety levels were assessed before and after the procedure using the State-Trait Anxiety Inventory-State (STAI-S) Scale. Institutional and ethics committee approvals, as well as informed consent, were obtained before the study.

Conditions

  • Anxiety
  • Family Planning
  • Music Intervention

Interventions

BEHAVIORAL

Music Listening (Binaural Beats via Gnaural)

Modern 'relaxation' music regularly includes binaural beats. Binaural beats can be defined as a sensation produced by the arrival of sine tones of different frequencies in each ear. This sensation is created by the difference in frequency between the two tones reaching the ear. Music with binaural beats has been associated with reduced anxiety and increased relaxation by activating theta and delta wavelengths in the electroencephalography (EEG). The authors used Gnaural (GPL-2.0), a freely programmable sound generator, for the binaural beats. Two pieces of instrumental 7 Hz binaural beats were used, a piano and an instrumental. The music volume was between 50-60 decibels and was at a level where the participant could hear the healthcare professional performing the procedure.

Sponsors & Collaborators

  • Şükriye ŞAHİN

    lead OTHER

Principal Investigators

  • Şükriye Şahin, PhD · Kocaeli University

  • Yasemin Özhanlı, Assistant Professor · Kocaeli University

  • Elif Ayfer Baltacı Yıldız, PhD · Bingol University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2025-03-10
Completion
2025-05-05

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038187 on ClinicalTrials.gov