Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer

NCT ID: NCT02583139

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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(Will be added later)

Conditions

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Cancer Chemotherapy-induced Nausea and Vomiting Effects of Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Narrative Group

Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives

Group Type EXPERIMENTAL

Designed Music Narratives

Intervention Type BEHAVIORAL

Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music.

The narrative and music reflect and support each other.

Control Group

Prescribed medical/chemotherapy treatment plus standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Designed Music Narratives

Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music.

The narrative and music reflect and support each other.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* Previous and/or acute psychiatric diagnosis
* Cognitive and mental deficits or impaired functioning
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Børnecancerfonden

OTHER

Sponsor Role collaborator

Ronald McDonalds Børnefond

OTHER

Sponsor Role collaborator

TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Ilan Sanfi

Music therapist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilan Sanfi, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospistal

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ilan Sanfi, PhD

Role: CONTACT

+4522973661

Stine C. Ærø, BA

Role: CONTACT

+47 92498316

Facility Contacts

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Lisbeth Rasmussen

Role: primary

+45 78 45 14 70

Other Identifiers

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MF-Cancer-Children-1

Identifier Type: -

Identifier Source: org_study_id

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