Receptive Music Interventions During Intradermal Testing in Children

Not Applicable

• Conditions: Music Therapy; Anxiety; Pain Management; Skin Tests; Child

• Registration Number: NCT07013669
• Lead Sponsor: Hilal Gungor

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-14
• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-07-06
• Study Completion: 2025-07-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Parental State Anxiety Levels	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	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.

Trial Locations

Locations (1)

Prof Dr Cemil Tascioglu Education and Research Hospital Organization; 🇹🇷 Istanbul, Şişli, Turkey