NCT00376922

Brief Summary

RATIONALE: Listening to relaxing music during a bone marrow biopsy may be effective in reducing anxiety and pain. PURPOSE: This randomized clinical trial is studying how well music works in reducing anxiety and pain in adult patients undergoing bone marrow biopsy for hematologic cancers or other diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 30, 2017

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

September 13, 2006

Last Update Submit

May 25, 2017

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsPainPrecancerous ConditionPsychosocial Effects of Cancer and Its Treatment

Keywords

painpsychosocial effects of cancer and its treatmentaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)atypical chronic myeloid leukemia, BCR-ABL1 negativeblastic phase chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesessential thrombocythemiaextramedullary plasmacytomameningeal chronic myelogenous leukemiamyelodysplastic/myeloproliferative neoplasm, unclassifiablepolycythemia verapreviously treated myelodysplastic syndromesprimary systemic amyloidosisprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage III adult T-cell leukemia/lymphomastage III chronic lymphocytic leukemiastage III multiple myelomastage IV adult T-cell leukemia/lymphomastage IV chronic lymphocytic leukemiarelapsing chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiamast cell leukemiastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomaT-cell large granular lymphocyte leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiarefractory hairy cell leukemiarecurrent adult T-cell leukemia/lymphomarefractory chronic lymphocytic leukemiauntreated hairy cell leukemiarecurrent adult Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent cutaneous T-cell non-Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaadult grade III lymphomatoid granulomatosisrecurrent adult grade III lymphomatoid granulomatosisWaldenström macroglobulinemiacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomarecurrent adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomarecurrent adult lymphoblastic lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomacontiguous stage II marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaisolated plasmacytoma of bonemonoclonal gammopathy of undetermined significancerefractory multiple myelomastage I multiple myelomastage II multiple myelomapost-transplant lymphoproliferative disorderprimary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

  • State anxiety as measured by the State-Trait Anxiety Inventory (STAI) questionnaire

    day 1

  • Perceived pain level as measured by the Visual Analogue Scale

    day 1

  • Patient satisfaction as measured by a post-procedure questionnaire

    day 1

Study Arms (2)

usual care

NO INTERVENTION

Music therapy

EXPERIMENTAL
Procedure: music therapy

Interventions

music therapyPROCEDURE

music played for patient during bone marrow biopsy collection

Music therapy

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of hematologic malignancy * Referred or scheduled for a bone marrow biopsy PATIENT CHARACTERISTICS: * Must understand written and spoken English PRIOR CONCURRENT THERAPY: * Prior bone marrow biopsies allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPainPrecancerous ConditionsLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseThrombocythemia, EssentialPolycythemia VeraImmunoglobulin Light-chain AmyloidosisLeukemia, ProlymphocyticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Mast-CellLeukemia, Large Granular LymphocyticLeukemia, Hairy CellHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneMonoclonal Gammopathy of Undetermined Significance

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, B-CellMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, T-CellLymphoma, T-CellLymphadenopathyEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellHypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Suzanne C. Danhauer, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2010

Last Updated

May 30, 2017

Record last verified: 2012-07

Locations

US(1)