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Completed

NCT Number: NCT07038187

Effect of Music on Anxiety Levels During Intrauterine Device Application

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.

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Key information

Conditions

Anxiety Anxiety Disorders Family Planning Mental Disorders Music Intervention

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

About this study

This randomized controlled study aimed to assess the effect of music on procedural anxiety in women undergoing IUD insertion. Randomization was performed using a computer-generated random number table prepared by a statistician. Each participant meeting the inclusion criteria was assigned to either the experimental or control group via opaque envelopes distributed in the order of clinic admission. The independent variable was music listening, and the dependent variable was anxiety level measured using the STAI-S Scale. Data were collected from women at a Community Health Center between January and May 2025. The study received ethical approval and informed consent was obtained from all participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women with hearing problems
  • Women with psychiatric diagnoses

Treatment and study plan

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.

Primary outcomes

  1. Anxiety severity

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

    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).

Secondary outcomes

  1. Trait Anxiety Severity

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

    Trait anxiety will be measured using the Trait Anxiety subscale of the Spielberger State-Trait Anxiety Inventory (STAI-T), consisting of 20 items rated on a 4-point Likert scale. This scale assesses the participant's general tendency toward anxiety.

Sponsors and collaborators

Lead sponsor

Şükriye ŞAHİN

Other

Registry information

Official study title

Effect of Music on Anxiety Levels During Intrauterine Device Application: A Randomized Controlled Trial

Acronym: RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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