Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663909
• Other study ID #: Scoliosis
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: August 9, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Canada	CHU Ste-Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No