Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion

Conditions
-----------------
Pain, Scoliosis

Intervention / Treatment
-----------------
* Behavioral: Guided imagery intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | |
| Experimental: Guided imagery<br> | Behavioral: Guided imagery intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety | 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 anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery | 
| Level of coping | 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. | Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive-behavioral interventions, Adolescents, Pain, Scoliosis, Rehabilitation