Effect of Music on Anxiety Levels During Intrauterine Device Application (RCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Music Intervention; Family Planning
• Intervention / Treatment: Behavioral: Music Listening (Binaural Beats via Gnaural)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey
    • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Listening with Binaural Beats; 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); 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.
No Intervention: Routine Care Without Music; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trait Anxiety Severity	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.	Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)

Collaborators and Investigators

• Sponsor: Şükriye ŞAHİN
• Investigators: Study Director: Şükriye Şahin, PhD, Kocaeli University; Study Chair: Yasemin Özhanlı, Assistant Professor, Kocaeli University; Study Chair: Elif Ayfer Baltacı Yıldız, PhD, Bingol University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: May 6, 2025
• First Submitted That Met QC Criteria: June 17, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; THERAPY; FAMİLY PLANNİNG
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2025/0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No