PainNCT01663909
Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
A study testing Guided imagery intervention in people with Pain and Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 11 to 20 years
- What is being tested?
- Guided imagery intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with a moderate cognitive deficit or severe mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion
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.
- Being tested
- Guided imagery intervention
- Keywords
- Pain, Scoliosis, Rehabilitation, Cognitive-behavioral interventions, Adolescents
- Medical subject headings
- Pain, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imagery interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Not described |
| Guided imagery | Experimental | Not described Receives: Behavioral: Guided imagery intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Level of pain intensity at two weeks after the surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Charette, St. Justine's Hospital
- Investigators
- Sylvie Le May, RN, PhD, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663909
- Sponsor's protocol ID
- Scoliosis
- Status last verified
- Aug 2012
- First submitted
- 27 Jun 2012
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion
- ClinicalTrials.gov ID
- NCT01663909
- Acronym / sponsor ID
- Scoliosis
- Keywords
- Pain, Scoliosis, Rehabilitation, Cognitive-behavioral interventions, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | – |
| Guided imagery | Experimental | Behavioral: Guided imagery intervention |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosed with a moderate cognitive deficit or severe mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided imagery interventionA 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images. | Behavioural | Guided imagery |
Primary outcome
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.
2 secondary outcomes
Level of anxiety
Time frame: Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery
Level of coping
Time frame: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Le May, RN, PhD study director
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery intervention in people with Pain and Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain intensity (time frame: Level of pain intensity at two weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.