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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

June 27, 2012
August 9, 2012
May 2010
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01663909 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Pain
  • Scoliosis
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.
  • No Intervention: Standard care
  • Experimental: Guided imagery
    Intervention: Behavioral: Guided imagery intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
11 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01663909
Scoliosis
No
Sylvie Charette, St. Justine's Hospital
St. Justine's Hospital
Not Provided
Study Director: Sylvie Le May, RN, PhD Université de Montréal
St. Justine's Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP