An interventional study of Guided Imagery and Music in Cancer, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Aarhus · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine whether a modified and resource-oriented form of Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in teenagers with cancer.
(Will be added later)
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Highly emetogenic chemotherapy:
Exclusion Criteria:
Prescribed medical/chemotherapy treatment plus standard care + Guided Imagery and Music
Behavioral: Guided Imagery and Music
Prescribed medical/chemotherapy treatment plus standard care
Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM)
Also known as: Music and imagery, music therapy, active music listening
Duration (minutes) of Acute Nausea
Self-reported duration og nausea in minutes during the first 32 hours after onset of chemotherapy
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Intensity of Acute Nausea as measured by the Visual Analogue Scale
Self-reported intensity of nausea, calculated as the average of the two measurements
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress regarding Acute Nausea as measured by the Visual Analogue Scale
Self-reported distress regarding nausea, calculated as the average of the two measurements
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Amount (mg/m2) of Nausea Reducing Medicine Consumed
Time frame: During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study
Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale
Self-reported side effects, calculated as the average of the two measurements. The Memorial Symptom Assessment Scale is a self-report composite measure that measures bodily and psychological symptoms of side effects
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Numbers of Acute Vomiting
Self-reported numbers of vomiting during the first 32 hours
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Duration (minutes) of Acute Pain
Self-reported duration of acute pain in minutes within the first 32 hours after onset of chemotherapy
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Acute Pain Intensity as measured by the Visual Analogue Scale
Self-reported intensity of pain, calculated as the average of the two measurements
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Number of Days to Absolute Neutrophil Count Recovery defined as ANC ≥ 0.5 x 109/L
Number of days before the immune system recovers after chemotherapy. In the study, Absolute Neutrophil Count Recovery (ANCR) is defined as ANCR ≥ 0.5 x 109/L. In addition, if no nadir \< 0.5 x 109/L occurs the period is 0 (zero).
Time frame: Time to Event: Measured Day 1 in 5th cycle of chemotherapy after enrolment in study - until first day with ANC ≥ 0.5 x 109/L after the nadir period (an expected average of 9-15 days)
Duration (minutes) of Acute Fatigue
Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress regarding Acute Fatigue as measured by a 5-point Likert-type Scale
Self-reported Distress regarding Acute Fatigue, calculated as the average of the two measurements
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Appraised food intake and appetite as measured by a 5-point Likert-type Scale
Self-reported appraised food intake, calculated as the average of the two measurements
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Weight (kg)
Time frame: Change between weight from during course 1 and course 5 after inclusion in study
Sense of Coherence as measured by the Antonovsky Sense of Coherence Scale
Self-report, registered once during 5th cycle of chemotherapy
Time frame: Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study
Satisfaction with music intervention as measured by a Likert-type Scale (participants in music group only)
Self-report, registered once during 5th cycle of chemotherapy
Time frame: Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus