Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02145221
Other study ID # 221-08
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT04988490 - Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes
Terminated NCT01694199 - A Multicenter, Randomized, Sham-Controlled, Double-Blinded Study to Evaluate the Analgesic Efficacy and Safety of Pulsed Radiofrequency Energy (PRFE) in Bunionectomy Surgery for the Treatment of Post-Operative Pain N/A
Recruiting NCT05657704 - Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol Phase 4
Recruiting NCT03421522 - Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain N/A
Completed NCT03730350 - Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning N/A
Completed NCT03933124 - The Effect of Virtual Reality on Post-surgical Pain and Recovery. N/A
Completed NCT03599089 - Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients Phase 2
Terminated NCT04085237 - ESP Block for Laparoscopic Nephrectomy Surgeries N/A
Completed NCT02807428 - Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery Phase 2
Completed NCT02523235 - Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks Phase 4