An interventional study of Live music and Taped music in Non Hodgkin´s Lymphomas and Hodgkin´s Lymphomas, sponsored by Margrethe Langer Bro. Completed at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Margrethe Langer Bro · Not applicable, Interventional, and Supportive care
Main purpose: To determine if live music moderates the level of chemotherapy related anxiety, in patients with haematological cancer
The investigators hypothesize that live music:
Method: Intervention groups:
Endpoints:
Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.
Background: In order to establish the intervention procedures, the investigators have carried out a pilot study at the hematology department at Hospital of Southwest Denmark, including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results indicates that live music has an uplifting, pain relieving, and then releasing effect and that music has a positive impact on hospitalisation. According to the evaluation forms filled out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy involves major physical and psychological problems. Not much has been provided in the clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the need for developing new potential areas of intervention that takes into account, that not only do cancer patients face challenges in everyday life ranging from physiological changes over social to psychological problems, but also during treatment procedures, which may cause a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This project investigates to what degree live music may relieve some of these symptoms during treatment for haematological cancer. The project is created in order to both measure psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These physiological changes are measured in order to shed light on the mechanism behind the potential effects of live music on discomfort in connection with chemotherapy treatment.
Perspectives: The vision of the project focus on strengthening the cancer patients' ability to cope with physiological and psychological issues during chemotherapy sessions and to make the patients conscious of music as an option in these coping efforts. Hopefully, the results will provide a scientific basis for an evaluation of the perspectives and the potentials of live music treatment during chemotherapy infusion among cancer patients.
5,624 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 143 is above the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →This is the only study on the registry with Margrethe Langer Bro as lead sponsor.
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Exclusion Criteria:
Patient preferred live music during chemotherapy session.
Other: Live music
Patient preferred taped music during chemotherapy
Other: Taped music
Usual care during chemotherapy
Anxiety (STAI)
STAI-S Spielberger State-Trait Anxiety Scale-State
Time frame: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
Serum catecholamines
Blood samples
Time frame: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
Nausea
Patient diary
Time frame: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
Quality of life
Quality of Life Questionnaire: QLQ-C30
Time frame: Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
Anxiety (HADS)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Distress
questionaire: The Distress Thermometer
Time frame: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
Anxiety (STAI)
STAI-S Spielberger State-Trait Anxiety Scale-State
Time frame: Measurement of STAI at baseline and after each chemotherapy 1 to 5 (on average 2, 4, 6 and 8 weeks after inclusion) as well as differences from baseline.
Ran from May 2013 to primary completion in Jan 2017, 44 months.
Of 180 non-industry interventional studies with no phase under Lymphoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 87. This study's 44 months is below that.
Counting every sponsor, half of 200 studies reached it within 47 months; a quarter within 24 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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