Receptive Music Interventions During Intradermal Testing in Children

NCT07013669 | Completed

• 1 other identifier: 2025-276166482
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  within 2 minutes post-procedure

Study Arms (3)

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

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

Behavioral: Receptive Music Therapy - Traditional Turkish Music

Interventions

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

Solfeggio Music Intervention

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.

Traditional Turkish Music Intervention

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hilal Gungor: lead

Study Sites (1)

Prof Dr Cemil Tascioglu Education and Research Hospital Organization

Istanbul, Şişli, 34360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Pediatric Allergy and Immunology

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 10, 2025
• Study Start: May 14, 2025
• Primary Completion: July 6, 2025
• Study Completion: July 14, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)