Clinical trial · Interventional
Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer
The Effect and Meaning of Designed Music Narratives on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Children (7-12 Years) With Cancer: a Randomized Controlled Multisite Study
NCT02583139CI-TRIAL-00022118unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
| Effects of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Designed Music Narratives | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music Narrative Group
- description
- Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives
- interventionNames
- Behavioral: Designed Music Narratives
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Prescribed medical/chemotherapy treatment plus standard care
Primary outcomes (1)
- measure
- Duration (minutes) of Acute Nausea
- timeFrame
- Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
- description
- Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 12 Years
Show eligibility criteria text
1. Children at the ages 7-12 2. Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting. The specific type of chemotherapy may vary across the four/five consecutive courses but shall include one of the following moderate and/or highly emetogenic types of chemotherapy: Moderate emetogenic chemotherapy: * Carboplatin * Cyclophosphamide \<1500 mg/m2 * Cytarabine \>1 g/m2 * Daunorubicin * Doxorubicin * Epirubicin * Idarubicin * Ifosfamide * Mitoxantrone * Methotrexate \>1000 mg/m2 Highly emetogenic chemotherapy: * Cisplatin \>25 mg/m2 * Cyclophosphamide \>1500 mg/m2 * Dacarbazine 3. Understand Norwegian/Danish 4. Parents must be able to read and understand Norwegian/Danish * No significant hearing impairment * Written and verbal informed consent from both possessors of the custody * Verbal informed consent from child/participant Exclusion Criteria: * Previous and/or acute psychiatric diagnosis * Cognitive and mental deficits or impaired functioning
References
Publications (0)
Data not yet available
No reference posted for this study.