Completed

Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma

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What is being tested

Music Imagery

Behavioral
Who is being recruted

Leukemia

+ Lymphoma, Non-Hodgkin
From 18 to 80 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2002

See protocol details

Summary

Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: August 18, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2002Actual date on which the first participant was enrolled.

The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma. Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients. Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.

Official TitleMusic Imagery for Patients in Protected Environments 
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: August 18, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Leukemia
Lymphoma, Non-Hodgkin
Criteria

Inclusion Criteria: * Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma * Able to read and understand English

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Indiana University Cancer Center/University HospitalIndianapolis, United StatesSee the location
CompletedOne Study Center