Complementary Therapies in Spinal Fusion Patients

September 12, 2017 updated by: Karen Sacks, Nemours Children's Clinic

A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients

In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 45 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Female adolescents with the diagnosis of idiopathic scoliosis requiring surgery will be approached by a member of the research team at the pre-surgical evaluation visit to participate in the study. Randomization will be done at the time of the pre-surgical visit. Microsoft Excel will be used to generate a random group assignment table to one of the following groups:

CONTROL GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery

HYPNOSIS GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion and Hypnosis intervention consisting of induction to achieve a state of focused attention with heightened receptivity for acceptable suggestions targeting relaxation, comfort and healing.

HEALING TOUCH GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery and Healing Touch intervention (Chakra Connection, Magnetic Clearing)

Protocol:

  1. Potential patients identified by Orthopedic surgery schedule and review of electronic medical record (EMR) for eligibility.
  2. Randomization of participants into group, CPASS anxiety scale and cortisol level obtained for all participants at preoperative visit.
  3. Day of surgery: Hypnosis intervention or Healing Touch intervention prior to surgical procedure by research staff
  4. Intra-operative procedure: Hypnosis participant will have taped Hypnosis script during surgical procedure; Healing Touch participant will receive one minute of intentional healing at designated time each hour by Healing Touch Practitioner. Cortisol level will be obtained on all participants.
  5. PACU procedure: Healing Touch intervention or Hypnosis intervention by research staff.
  6. POD #1 until discharge: daily Healing Touch or Hypnosis intervention by research staff
  7. POD # 2: CPASS anxiety scale and cortisol level obtained on all participants
  8. Post-op analgesic regimen: Morphine PCA > 50 kg (demand 1 mg, 10 minute lockout, basal rate 0.5 mg/hr) and Morphine PCA < 40-49 kg (demand 0.8 mg, 10 minute lockout, basal rate 0.4 mg/hr), benzodiazepine, gabapentin, ketorolac and clonidine per standard protocol for all participants.
  9. Pain scores (self-report), vital signs, opioid consumption, side effects, day of ambulation, transition to oral analgesics will be collected from EMR until day of discharge.
  10. 4-week Postoperative visit: CPASS anxiety scale, cortisol level and pill count obtained on all participants.

Methods:

Statistical Analysis: Descriptive Statistics: Standard Descriptive Statistics will be used to describe the outcomes, demographic and independent variables of interest pre- and post-intervention, overall and by intervention group. Changes in outcomes will also be calculated and descried. For continuous variables means, medians and ranges will be produced, while frequencies and percentages will be produced for categorical variables. Means, standard deviations, medians and ranges will be computed for measured continuous variables; marginal distributions will be used for categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used in order to understand aspects of data quantity and examine assumptions (such as normality) underlying statistical models.

The primary outcome is decrease in opioid consumption as well as reported pain and anxiety scores. We will compare difference in pain pre- to post- between the two intervention and control groups, using ANOVA. Since data will be collected at multiple points pre- and post-intervention, and some randomly missing data expected, the primary analysis will employ generalized estimating equations (GEEs). The GEEs models will be adjusted for baseline characteristics, such as age, gender, race and any important clinical characteristics. GEEs will also be used to compare the changes in reported pain and analgesic use between the three groups.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours / A I duPont Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Females, ages 12 - 17
  2. Diagnosis of idiopathic scoliosis

Exclusion Criteria:

  1. Patients with chronic or severe disease conditions requiring spinal fusion surgery.
  2. Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hypnosis Group
Hypnosis Group: fifteen participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol
Other: Hypnosis Therapy
A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness
ACTIVE_COMPARATOR: Healing Touch Group
Healing Touch Group: fifteen participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol
Other: Healing Touch Therapy
Healing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing.
NO_INTERVENTION: Control Group
Control Group will receive standard postoperative pain management protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain (Total Opioid use)
Time Frame: 4 weeks
Total Opioid use will be measured daily until discharge, and at postoperative follow-up visit
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical recovery (Postoperative parameters - nausea / vomiting; day of ambulation; transition to oral pain medication; length of stay followed daily until discharge)
Time Frame: 1 week
1 week
Cortisol level
Time Frame: 5 weeks
Cortisol levels will be obtained at 4 points - pre-operative surgical evaluation visit, intra-operative, POD #2, 4-week postoperative follow-up clinic visit.
5 weeks
Anxiety (Child Pain Anxiety Symptoms Scale (CPASS)
Time Frame: 5 weeks
The Child Pain Anxiety Symptoms Scale (CPASS) is a validated 20-item self-report tool measuring pain anxiety in adolescents undergoing major surgical procedures and will obtained on all participants at 3 points - presurgical evaluation, POD #2 and 4-week postoperative follow-up visit.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

Healing Touch Worldwide Foundation

Investigators

  • Principal Investigator: Karen Sacks, MSN, PNP, Nemours / A I duPont Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

March 27, 2017

Study Completion (ACTUAL)

March 27, 2017

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (ESTIMATE)

April 7, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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