Clinical trial NCT02409615: Complementary Therapies in Spinal Fusion Patients
Official title: A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Complementary therapies
Hypnosis
Healing Touch
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Healing Touch Worldwide Foundation
First posted: 2015-04-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 30 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain (Total Opioid Use)
timeFrame: up to postoperative day 4
Secondary outcomes:
measure: Pain Score
timeFrame: up to postoperative day 4
measure: Cortisol Level
timeFrame: up to 4-week postoperatively
measure: Child Pain Anxiety Symptoms Scale (CPASS)
timeFrame: up to 4 weeks postoperatively
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours / A I duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours / A I duPont Hospital for Children
name: Karen Sacks, MSN, PNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemper KJ, Vohra S, Walls R; Task Force on Complementary and Alternative Medicine; Provisional Section on Complementary, Holistic, and Integrative Medicine. American Academy of Pediatrics. The use of complementary and alternative medicine in pediatrics. Pediatrics. 2008 Dec;122(6):1374-86. doi: 10.1542/peds.2008-2173.
citation: Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23.
citation: Sanders H, Davis MF, Duncan B, Meaney FJ, Haynes J, Barton LL. Use of complementary and alternative medical therapies among children with special health care needs in southern Arizona. Pediatrics. 2003 Mar;111(3):584-7. doi: 10.1542/peds.111.3.584.
citation: Post-White J, Fitzgerald M, Hageness S, Sencer SF. Complementary and alternative medicine use in children with cancer and general and specialty pediatrics. J Pediatr Oncol Nurs. 2009 Jan-Feb;26(1):7-15. doi: 10.1177/1043454208323914. Epub 2008 Oct 20.
citation: Hagen LE, Schneider R, Stephens D, Modrusan D, Feldman BM. Use of complementary and alternative medicine by pediatric rheumatology patients. Arthritis Rheum. 2003 Feb 15;49(1):3-6. doi: 10.1002/art.10931.
citation: Lew MW, Kravits K, Garberoglio C, Williams AC. Use of preoperative hypnosis to reduce postoperative pain and anesthesia-related side effects. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):406-23. doi: 10.1080/00207144.2011.594737.
citation: Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.