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
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started May 2010
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedAugust 13, 2012
August 1, 2012
1.3 years
June 27, 2012
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of pain intensity
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.
Level of pain intensity at two weeks after the surgery
Secondary Outcomes (2)
Level of anxiety
Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery
Level of coping
Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
Study Arms (2)
Standard care
NO INTERVENTIONGuided imagery
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diagnosed with a moderate cognitive deficit or severe mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Ste-Justine Hospital
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sylvie Le May, RN, PhD
Université de Montréal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Nurse Specialist
Study Record Dates
First Submitted
June 27, 2012
First Posted
August 13, 2012
Study Start
May 1, 2010
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
August 13, 2012
Record last verified: 2012-08