Effect of Music on Anxiety Levels During Intrauterine Device Application

Not Applicable

Completed

• Conditions: Anxiety; Family Planning; Music Intervention

• Registration Number: NCT07038187
• Lead Sponsor: Şükriye ŞAHİN

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.

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 Timeline

• Study Start: 2025-01-22
• Primary Completion: 2025-03-10
• Study Completion: 2025-05-05
• Study First Submitted: 2025-05-06
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety severity	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 Outcome Measures

Name	Time	Method
Trait Anxiety Severity	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.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey