Effects of Music Therapy on the Recovery of Patients Undergoing Spine Surgery
Primary Purpose
Post-surgical Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by

About this trial
This is an interventional supportive care trial for Post-surgical Pain
Eligibility Criteria
Inclusion Criteria:
- Male or female ages 40-55 undergoing anterior, posterior, or anterior/posterior spinal fusion.
- Minorities and patients with Medicaid and Medicare will be included.
Exclusion Criteria:
- Individuals under the age of 40 and over the age of 55.
- Exclusions will also include patients with a diagnosis of clinical psychosis and/or depression that pre-termed the spine injury.
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music therapy
No intervention
Arm Description
Music therapy post surgery
Outcomes
Primary Outcome Measures
pain reduction
Does music therapy intervention impact the experience of pain in patients recovering from spinal surgery.
Secondary Outcome Measures
reduction of hospiral anxiety related to pain
Does music therapy reduce anxiety in patients recovering from spinal surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02145221
Brief Title
Effects of Music Therapy on the Recovery of Patients Undergoing Spine Surgery
Official Title
The Effects of Music Therapy in the Recovery of Patients Undergoing Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are studying music therapy as an incentive and adjunct to a comprehensive spine surgery rehabilitation-recuperation program. Through the use of music therapy psychosocial support is motivated by the clinical use of music. The program will investigate the use of music therapy as an option for managing symptoms associated with spine surgery recovery. The proposed program will investigate the use of music therapy as an integrative treatment within Beth Israel's Department of Spine Surgery.This study will investigate the effects of music therapy in managing spine surgery recuperation and to reduce the intensity and experience of pain. Outcomes will include: Pain (pain medication dosage and patient report) using a CAS Color Analysis Scale and the VAS Pain Rating Scale, level of self-reliance/independence using physical therapy assessment scale, cooperation through evaluating number of times patient declined/accepted services, length of stay, patient satisfaction/patient report, level of kinesiophobia using the Tampa Scale for Kinesiophobia and anxiety/depression using the HADS during the period post-spine surgery.(see attached scales in Appendix section)
Detailed Description
The proposed research will combine traditional medical care with an integrative model of care; music therapy will be an integrative intervention and we will study the effects of music therapy interventions, which include: clinical improvisation, rhythm which can enhance assisted walk and music-assisted physical movement which may encourage patients to experience a greater tolerance to pain, improving gait, range of motion, endurance, and the ability to relax, motivation to participate in daily activities.
Methodology:The primary goals are to assess pain, independence, compliance, length of stay, patient satisfaction/patient report, level of kinesiophobia and anxiety/depression related to medical condition during the period post-spine surgery.
Design of the Study:This study will use quantitative and qualitative methodologies. A randomized control design that will include two groups of patients that will be targeted to include up to 60 male and female patients.
The experimental group will receive music therapy and standard care and a second group will serve as a wait-listed control, receiving only standard care. Patients with undergoing ASP, PSF or A/PSF will be placed with consent randomly into the experimental or control group. Patients belonging to the experimental group will receive one music therapy session after surgery.
For both groups, the VAS Pain Rating Scale, the HADS - Hospitalization Anxiety/Depression Scale, the Tampa Scale for Kinesiophobia, and the Color Analysis Scale will be introduced. For both groups of patients measurements will be logged before and after the music therapy session, or no intervention during the same time period.
Procedure: Patients will be recruited by the attending doctor, nurse, physical therapist and/or social worker. Patients in the experimental group will participate in an active music-listening and active music-making session post-spine surgery.
The music therapy session will last approximately 30 minutes and will encourage patients to engage in active music-making to release pain, and to reduce anxiety/fear related to surgery and recuperation. The music therapy sessions will include:
Warm up: Verbal or musical discourse
Treatment section: Based upon assessment of patient's needs during the warm up, treatment options will include the use of live music and either:
Tension release/relaxation through entrained music visualization or Incentive-based play through clinical improvisation or rhythmic drumming
Closure/Integration (if awake) to reflect upon the session and issues that may have arisen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Music therapy post surgery
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Music Therapy
Primary Outcome Measure Information:
Title
pain reduction
Description
Does music therapy intervention impact the experience of pain in patients recovering from spinal surgery.
Time Frame
within a 24 hour period
Secondary Outcome Measure Information:
Title
reduction of hospiral anxiety related to pain
Description
Does music therapy reduce anxiety in patients recovering from spinal surgery
Time Frame
24 hour period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ages 40-55 undergoing anterior, posterior, or anterior/posterior spinal fusion.
Minorities and patients with Medicaid and Medicare will be included.
Exclusion Criteria:
Individuals under the age of 40 and over the age of 55.
Exclusions will also include patients with a diagnosis of clinical psychosis and/or depression that pre-termed the spine injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne V. Loewy, DA
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Music Therapy on the Recovery of Patients Undergoing Spine Surgery
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