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Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sylvie Charette, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01663909
First received: June 27, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. Several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. The investigators developed a DVD on guided imagery, customized for teenagers, to help them cope better with their pain. The investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.


Condition Intervention
Pain
Scoliosis
 Behavioral: Guided imagery intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Level of pain intensity [ Time Frame: Level of pain intensity at two weeks after the surgery ] [ Designated as safety issue: No ]
    Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.


Secondary Outcome Measures:
  • Level of anxiety [ Time Frame: Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery ] [ Designated as safety issue: No ]
    Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.

  • Level of coping [ Time Frame: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery ] [ Designated as safety issue: No ]
    Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.


Enrollment: 40
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Experimental: Guided imagery Behavioral: Guided imagery intervention
A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.

  Eligibility

Ages Eligible for Study:   11 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 11 and 20 years old
  • Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis
  • Able to write and understand French
  • Requires a computer or DVD player at home.

Exclusion Criteria:

  • Diagnosed with a moderate cognitive deficit or severe mental retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663909

Locations
Canada, Quebec
CHU Ste-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Study Director: Sylvie Le May, RN, PhD Université de Montréal
  More Information

No publications provided

Responsible Party: Sylvie Charette, Clinical Nurse Specialist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01663909     History of Changes
Other Study ID Numbers: Scoliosis
Study First Received: June 27, 2012
Last Updated: August 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Pain
Scoliosis
Rehabilitation
Cognitive-behavioral interventions
Adolescents

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 17, 2013