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Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663909
First Posted: August 13, 2012
Last Update Posted: August 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sylvie Charette, St. Justine's Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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

Primary Outcome Measures:
  • Level of pain intensity [ Time Frame: Level of pain intensity at two weeks after the surgery ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sylvie Charette, Clinical Nurse Specialist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01663909     History of Changes
Other Study ID Numbers: Scoliosis
First Submitted: June 27, 2012
First Posted: August 13, 2012
Last Update Posted: August 13, 2012
Last Verified: August 2012

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

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