Effect of Music on Anxiety Levels During Intrauterine Device Application

NCT07038187 | Completed DMC

• 1 other identifier: 2025/0101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

THERAPY; FAMİLY PLANNİNG; Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety severity

  Anxiety severity will be measured using the State Anxiety subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S). Participants will respond to 20 items using a 4-point Likert scale (1 = Not at all, 2 = Somewhat, 3 = Moderately so, 4 = Very much so).

  Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)

Secondary Outcomes (1)

• Trait Anxiety Severity

  Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)

Study Arms (2)

Music Listening with Binaural Beats

EXPERIMENTAL

Participants in the experimental group will listen to instrumental music embedded with 7 Hz binaural beats (theta range) generated using Gnaural (GPL-2.0 licensed, programmable sound generator). The tracks include piano and instrumental music played at a volume of 50-60 dB, allowing communication with the healthcare provider. Music will be delivered via headphones for approximately 30 minutes (20 minutes before and during the procedure). STAI-I and STAI-II scores will be assessed pre- and post-procedure.

Behavioral: Music Listening (Binaural Beats via Gnaural)

Routine Care Without Music

NO INTERVENTION

Participants in the control group will receive standard care during IUD insertion. No music or other additional intervention will be applied. STAI-I and STAI-II scores will be measured before and after the procedure.

Interventions

Music Listening (Binaural Beats via Gnaural) BEHAVIORAL

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.

Music Listening with Binaural Beats

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female participants were included in the study because intrauterine device (IUD) was used as a family planning method.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who will have an IUD for the first time
• Women aged 18-45

You may not qualify if:

• Women with hearing problems
• Women with psychiatric diagnoses

Sponsors & Collaborators

• Şükriye ŞAHİN: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Şükriye Şahin, PhD

  Kocaeli University

  STUDY DIRECTOR

• Yasemin Özhanlı, Assistant Professor

  Kocaeli University

  STUDY CHAIR

• Elif Ayfer Baltacı Yıldız, PhD

  Bingol University

  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: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 26, 2025
• Study Start: January 22, 2025
• Primary Completion: March 10, 2025
• Study Completion: May 5, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)