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

NCT02145221 | Completed

• 1 other identifier: 221-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• pain reduction

  Does music therapy intervention impact the experience of pain in patients recovering from spinal surgery.

  within a 24 hour period

Secondary Outcomes (1)

• reduction of hospiral anxiety related to pain

  24 hour period

Study Arms (2)

Music therapy

EXPERIMENTAL

Music therapy post surgery

Other: Music Therapy

No intervention

NO INTERVENTION

Interventions

Music Therapy OTHER

Music therapy

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female ages 40-55 undergoing anterior, posterior, or anterior/posterior spinal fusion.
• Minorities and patients with Medicaid and Medicare will be included.

You may not qualify if:

• Individuals under the age of 40 and over the age of 55.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joanne V. Loewy, DA

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 22, 2014
• Study Start: January 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)