Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01870479
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2013-04-09
Brief Title:
Music Cancer - Live Music During Chemotherapy
Sponsor:
Margrethe Langer Bro
Organization:
University of Southern Denmark
Study Overview
Official Title:
Music Cancer - Live Music During Chemotherapy Randomized Study of the Effect of Live Music During Chemotherapy Treatment
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
2 May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients
3 Is more effective in patients with good musical abilities
4 Is more effective than taped music
Method Intervention groups
1 Listening to patient-preferred live music during chemotherapy
2 Listening to patient-preferred taped music during chemotherapy
3 Standard care
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 anchoragecohesion 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 eg chemotherapy infusionThis 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 ie 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
The investigators hypothesize that live music
1 Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
2 May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients
3 Is more effective in patients with good musical abilities
4 Is more effective than taped music
Method Intervention groups
1 Listening to patient-preferred live music during chemotherapy
2 Listening to patient-preferred taped music during chemotherapy
3 Standard care
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 anchoragecohesion 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 eg chemotherapy infusionThis 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None