NCT01663909

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2010

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
Last Updated

August 13, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

June 27, 2012

Last Update Submit

August 9, 2012

Conditions

Keywords

PainScoliosisRehabilitationCognitive-behavioral interventionsAdolescents

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 INTERVENTION

Guided imagery

EXPERIMENTAL
Behavioral: Guided imagery intervention

Interventions

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.

Guided imagery

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

PainScoliosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sylvie Le May, RN, PhD

    Université de Montréal

    STUDY DIRECTOR

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

Locations