Effects of Music Therapy on the Recovery of Patients Undergoing Spine Surgery

Post-surgical Pain Clinical Trial

Official title:

The Effects of Music Therapy in the Recovery of Patients Undergoing Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145221
• Other study ID #: 221-08
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: May 21, 2014
• Start date: January 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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:

1. Warm up: Verbal or musical discourse

2. 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

3. Closure/Integration (if awake) to reflect upon the session and issues that may have arisen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Post-surgical Pain

Intervention

Other:
• Music Therapy

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain reduction	Does music therapy intervention impact the experience of pain in patients recovering from spinal surgery.	within a 24 hour period	No
Secondary	reduction of hospiral anxiety related to pain	Does music therapy reduce anxiety in patients recovering from spinal surgery	24 hour period	No