Receptive Music Interventions During Intradermal Testing in Children

NCT ID: NCT07013669

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2025-07-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Participants undergo standard intradermal testing (IDT) without any additional auditory intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Solfeggio Music Intervention

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

Group Type: EXPERIMENTAL

Receptive Music Therapy - Solfeggio Frequencies

Intervention Type: 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

Traditional Turkish Music Intervention

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

Group Type: EXPERIMENTAL

Receptive Music Therapy - Traditional Turkish Music

Intervention Type: 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.

Interventions

Receptive Music Therapy - Solfeggio Frequencies

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

Intervention Type: BEHAVIORAL

Receptive Music Therapy - Traditional Turkish Music

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Children aged between 2 and 17 years

2. Referred to the Pediatric Allergy Clinic for evaluation of suspected drug hypersensitivity reactions

3. Accompanied by a parent or legal guardian willing to participate

4. Written informed consent obtained from parents or legal guardians

Exclusion Criteria

1. Known neurological, psychiatric, or developmental disorders in the child

2. Use of sedatives or analgesic medications within 24 hours prior to testing

3. Hearing impairment or auditory processing disorders in the child4.Non-consent or withdrawal of consent by parent or guardian

4. Inability of the parent to complete anxiety assessments (e.g., due to language or cognitive barriers)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hilal Gungor

OTHER

Sponsor Role: lead

Responsible Party

Hilal Gungor

Medical Doctor, Pediatric Allergy and Immunology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Prof Dr Cemil Tascioglu Education and Research Hospital Organization

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025-276166482

Identifier Type: -

Identifier Source: org_study_id