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Completed

NCT Number: NCT07013669

Receptive Music Interventions During Intradermal Testing in Children

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.

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Key information

Conditions

Music Therapy Agnosia Anxiety Anxiety Disorders Child Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Tests

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof Dr Cemil Tascioglu Education and Research Hospital Organization

Istanbul, Şişli, 34360, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Receptive Music Therapy - Solfeggio Frequencies

Behavioral

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 Music

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hilal Gungor

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Dec 8, 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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