AnxietyRCTNCT07038187
Effect of Music on Anxiety Levels During Intrauterine Device Application
A study testing Music Listening (Binaural Beats via Gnaural) in people with Anxiety and Family Planning, run by Şükriye ŞAHİN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anxiety, Family Planning, Music Intervention
- What is being tested?
- Music Listening (Binaural Beats via Gnaural)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who will have an IUD for the first time
- Women aged 18-45
Who cannot join
- Women with hearing problems
- Women with psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Family Planning, Music Intervention
- Being tested
- Music Listening (Binaural Beats via Gnaural)
- Keywords
- THERAPY, FAMİLY PLANNİNG, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening (Binaural Beats via Gnaural)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)
Secondary outcomes (1)
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.
Measured: Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start22 Jan 2025
- Primary completion10 Mar 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şükriye ŞAHİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şükriye ŞAHİN, Kocaeli University
- Investigators
- Şükriye Şahin, PhD, Study director, Kocaeli UniversityYasemin Özhanlı, Assistant Professor, Study chair, Kocaeli UniversityElif Ayfer Baltacı Yıldız, PhD, Study chair, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038187
- Sponsor's protocol ID
- 2025/0101
- Acronym
- RCT
- Status last verified
- Jun 2025
- First submitted
- 6 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Anxiety Levels During Intrauterine Device Application: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07038187
- Acronym / sponsor ID
- RCT / 2025/0101
- Conditions
- Anxiety, Family Planning, Music Intervention
- Keywords
- THERAPY, FAMİLY PLANNİNG, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Şükriye ŞAHİNUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Music Listening with Binaural Beats | Experimental | Behavioral: Music Listening (Binaural Beats via Gnaural)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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who will have an IUD for the first time
- Women aged 18-45
Key exclusion criteria (2 listed)
- Women with hearing problems
- Women with psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Music Listening with Binaural Beats |
Primary outcome
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).
1 secondary outcome
Trait Anxiety Severity
Time frame: Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şükriye Şahin, PhD study director
Kocaeli University
Yasemin Özhanlı, Assistant Professor study chair
Kocaeli University
Elif Ayfer Baltacı Yıldız, PhD study chair
Bingol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening (Binaural Beats via Gnaural) in people with Anxiety and Family Planning, run by Şükriye ŞAHİN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety severity (time frame: Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.