Music TherapyNCT07013669
Receptive Music Interventions During Intradermal Testing in Children
A study testing Receptive Music Therapy - Solfeggio Frequencies and Receptive Music Therapy - Traditional Turkish Music in people with Music Therapy and Anxiety, run by Hilal Gungor at 1 site in Turkey (Türkiye).
Trial summary
The study summary and design were to assess procedural anxiety and stress in parents and pain perception in children during intradermal testing. Music medicine was incorporated into the study design as a nonpharmacological intervention. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Music Therapy, Anxiety, Pain Management
- What is being tested?
- Receptive Music Therapy - Solfeggio Frequencies and Receptive Music Therapy - Traditional Turkish Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2025to 14 Jul 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged between 2 and 17 years
- Referred to the Pediatric Allergy Clinic for evaluation of suspected drug hypersensitivity reactions
- Accompanied by a parent or legal guardian willing to participate
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Known neurological, psychiatric, or developmental disorders in the child
- Use of sedatives or analgesic medications within 24 hours prior to testing
- Hearing impairment or auditory processing disorders in the child4.Non-consent or withdrawal of consent by parent or guardian
- Inability of the parent to complete anxiety assessments (e.g., due to language or cognitive barriers)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu Education and Research Hospital Organization
Istanbul, Şişli, 34360
About this study
Official title: Receptive Music Interventions During Intradermal Testing in Children: A Randomized Controlled Trial Comparing Solfeggio Frequencies and Turkish Classical Music on Pain and Parental Anxiety
The study summary and design were to assess procedural anxiety and stress in parents and pain perception in children during intradermal testing. Music medicine was incorporated into the study design as a nonpharmacological intervention. Two distinct auditory modalities were used: solfeggio frequencies-174 Hz, 285 Hz, 396 Hz, and 528 Hz-which have been suggested to interact with the human energy field through resonance-based mechanisms, and Turkish classical musical modes (makams), such as Rast, Hicaz, Uşşak, Neva, and Saba, which are modal systems that include microtonal intervals and follow specific melodic progressions that are often associated with different emotional and spiritual effects as well as sensory and emotional regulation potential.
- Conditions
- Music Therapy, Anxiety, Pain Management, Skin Tests, Child
- Being tested
- Receptive Music Therapy - Solfeggio Frequencies, Receptive Music Therapy - Traditional Turkish Music
- Medical subject headings
- Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receptive Music Therapy - Solfeggio FrequenciesBehavioural
Music featuring Solfeggio frequencies (174 Hz, 285 Hz, 396 Hz, 528 Hz) is played through standardized speakers in a sound-isolated room during IDT. Duration includes five minutes before and throughout the procedure
Receptive Music Therapy - Traditional Turkish MusicBehavioural
Selected Turkish Classical Music pieces (makams: Rast, Hicaz, Uşşak, Neva, Saba) are played via speakers in a sound-isolated room during IDT. Music begins five minutes prior and continues during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants undergo standard intradermal testing (IDT) without any additional auditory intervention |
| Solfeggio Music Intervention | Experimental | Participants receive receptive music therapy using Solfeggio frequencies (174 Hz, 285 Hz, 396 Hz, and 528 Hz) during the IDT procedure. Music starts five minutes before and continues throughout the procedure Receives: Behavioral: Receptive Music Therapy - Solfeggio Frequencies |
| Traditional Turkish Music Intervention | Experimental | Participants receive receptive music therapy using selected Traditional Turkish Music modes (makams), including Rast, Hicaz, Uşşak, Neva, and Saba, during the IDT procedure. Music starts five minutes before and continues throughout the procedure Receives: Behavioral: Receptive Music Therapy - Traditional Turkish Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental State Anxiety Levels
Change in parental state anxiety will be assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S is a validated psychological inventory that measures current levels of anxiety. It consists of 20 items, each rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety.
STAI-S scores will be collected immediately before and immediately after the intradermal testing (IDT) procedure. The change in anxiety levels will be calculated as the difference between post-procedure and pre-procedure scores (ΔSTAI-S), and will be used to evaluate the effect of the intervention.
Measured: within 5 minutes before and post procedure
Pain Levels in Pediatric Patients During Intradermal Testing
Pain scores will be evaluated immediately after the intradermal testing (IDT) procedure.
For children under 5 years of age, pain will be assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This is a behavioral pain assessment tool with scores ranging from 4 to 13, where higher scores indicate greater pain.
For children aged 5 years and older, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. This self-report scale ranges from 0 to 10, where higher scores indicate greater pain.
Measured: within 2 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start14 May 2025
- Primary completion6 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Gungor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Gungor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013669
- Sponsor's protocol ID
- 2025-276166482
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identified individual participant data (IPD) that underlie the results reported in this article will be shared. This includes:Demographic information (age, sex, parental education level)Baseline clinical data (allergy history, suspected drug, clinical symptoms)Pre- and post-intervention STAI scores (State and Trait Anxiety Inventory)Pain scores measured using CHEOPS and Wong-Baker FACES scalesGroup allocation (Control, Solfeggio, Traditional Turkish Music)All shared data will be anonymized to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Receptive Music Interventions During Intradermal Testing in Children: A Randomized Controlled Trial Comparing Solfeggio Frequencies and Turkish Classical Music on Pain and Parental Anxiety
- ClinicalTrials.gov ID
- NCT07013669
- Acronym / sponsor ID
- 2025-276166482
- Conditions
- Music Therapy, Anxiety, Pain Management, Skin Tests, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hilal GungorUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 6 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 10 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.
The study summary and design were to assess procedural anxiety and stress in parents and pain perception in children during intradermal testing. Music medicine was incorporated into the study design as a nonpharmacological intervention. Two distinct auditory modalities were used: solfeggio frequencies-174 Hz, 285 Hz, 396 Hz, and 528 Hz-which have been suggested to interact with the human energy field through resonance-based mechanisms, and Turkish classical musical modes (makams), such as Rast, Hicaz, Uşşak, Neva, and Saba, which are modal systems that include microtonal intervals and follow specific melodic progressions that are often associated with different emotional and spiritual effects as well as sensory and emotional regulation potential.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants undergo standard intradermal testing (IDT) without any additional auditory intervention |
| Solfeggio Music Intervention | Experimental | Behavioral: Receptive Music Therapy - Solfeggio FrequenciesParticipants receive receptive music therapy using Solfeggio frequencies (174 Hz, 285 Hz, 396 Hz, and 528 Hz) during the IDT procedure. Music starts five minutes before and continues throughout the procedure |
| Traditional Turkish Music Intervention | Experimental | Behavioral: Receptive Music Therapy - Traditional Turkish MusicParticipants receive receptive music therapy using selected Traditional Turkish Music modes (makams), including Rast, Hicaz, Uşşak, Neva, and Saba, during the IDT procedure. Music starts five minutes before and continues throughout the procedure |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged between 2 and 17 years
- Referred to the Pediatric Allergy Clinic for evaluation of suspected drug hypersensitivity reactions
- Accompanied by a parent or legal guardian willing to participate
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- Known neurological, psychiatric, or developmental disorders in the child
- Use of sedatives or analgesic medications within 24 hours prior to testing
- Hearing impairment or auditory processing disorders in the child4.Non-consent or withdrawal of consent by parent or guardian
- Inability of the parent to complete anxiety assessments (e.g., due to language or cognitive barriers)
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 |
|---|---|---|
| Receptive Music Therapy - Solfeggio FrequenciesMusic featuring Solfeggio frequencies (174 Hz, 285 Hz, 396 Hz, 528 Hz) is played through standardized speakers in a sound-isolated room during IDT. Duration includes five minutes before and throughout the procedure | Behavioural | Solfeggio Music Intervention |
| Receptive Music Therapy - Traditional Turkish MusicSelected Turkish Classical Music pieces (makams: Rast, Hicaz, Uşşak, Neva, Saba) are played via speakers in a sound-isolated room during IDT. Music begins five minutes prior and continues during the procedure. | Behavioural | Traditional Turkish Music Intervention |
Primary outcome
Change in Parental State Anxiety Levels
Time frame: within 5 minutes before and post procedure
Change in parental state anxiety will be assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S is a validated psychological inventory that measures current levels of anxiety. It consists of 20 items, each rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety. STAI-S scores will be collected immediately before and immediately after the intradermal testing (IDT) procedure. The change in anxiety levels will be calculated as the difference between post-procedure and pre-procedure scores (ΔSTAI-S), and will be used to evaluate the effect of the intervention.
Pain Levels in Pediatric Patients During Intradermal Testing
Time frame: within 2 minutes post-procedure
Pain scores will be evaluated immediately after the intradermal testing (IDT) procedure. For children under 5 years of age, pain will be assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This is a behavioral pain assessment tool with scores ranging from 4 to 13, where higher scores indicate greater pain. For children aged 5 years and older, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. This self-report scale ranges from 0 to 10, where higher scores indicate greater pain.
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 8 Dec 2025.
- Individual participant dataSharing planned: Yes. Identified individual participant data (IPD) that underlie the results reported in this article will be shared. This includes:Demographic information (age, sex, parental education level)Baseline clinical data (allergy history, suspected drug, clinical symptoms)Pre- and post-intervention STAI scores (State and Trait Anxiety Inventory)Pain scores measured using CHEOPS and Wong-Baker FACES scalesGroup allocation (Control, Solfeggio, Traditional Turkish Music)All shared data will be anonymized to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receptive Music Therapy - Solfeggio Frequencies and Receptive Music Therapy - Traditional Turkish Music in people with Music Therapy and Anxiety, run by Hilal Gungor 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 4 inclusion and 4 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 8 Dec 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?
Change in Parental State Anxiety Levels (time frame: within 5 minutes before and post procedure). The study lists 2 primary outcomes in all. 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 8 Dec 2025.