Idiopathic ScoliosisNCT02409615
Complementary Therapies in Spinal Fusion Patients
A study testing Hypnosis Therapy and Healing Touch Therapy in people with Idiopathic Scoliosis, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Hypnosis Therapy and Healing Touch Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 27 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Females, ages 12 - 17
- Diagnosis of idiopathic scoliosis
Who cannot join
- Patients with chronic or severe disease conditions requiring spinal fusion surgery.
- Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours / A I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 30 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).
Read the detailed description
Female adolescents with the diagnosis of idiopathic scoliosis requiring surgery will be approached by a member of the research team at the pre-surgical evaluation visit to participate in the study. Randomization will be done at the time of the pre-surgical visit. Microsoft Excel will be used to generate a random group assignment table to one of the following groups:
CONTROL GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery
HYPNOSIS GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion and Hypnosis intervention consisting of induction to achieve a state of focused attention with heightened receptivity for acceptable suggestions targeting relaxation, comfort and healing.
HEALING TOUCH GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery and Healing Touch intervention (Chakra Connection, Magnetic Clearing)
Protocol:
- Potential patients identified by Orthopedic surgery schedule and review of electronic medical record (EMR) for eligibility.
- Randomization of participants into group, CPASS anxiety scale and cortisol level obtained for all participants at preoperative visit.
- Day of surgery: Hypnosis intervention or Healing Touch intervention prior to surgical procedure by research staff
- Intra-operative procedure: Hypnosis participant will have taped Hypnosis script during surgical procedure; Healing Touch participant will receive one minute of intentional healing at designated time each hour by Healing Touch Practitioner. Cortisol level will be obtained on all participants.
- PACU procedure: Healing Touch intervention or Hypnosis intervention by research staff.
- POD #1 until discharge: daily Healing Touch or Hypnosis intervention by research staff
- POD # 2: CPASS anxiety scale and cortisol level obtained on all participants
- Post-op analgesic regimen: Morphine PCA > 50 kg (demand 1 mg, 10 minute lockout, basal rate 0.5 mg/hr) and Morphine PCA < 40-49 kg (demand 0.8 mg, 10 minute lockout, basal rate 0.4 mg/hr), benzodiazepine, gabapentin, ketorolac and clonidine per standard protocol for all participants.
- Pain scores (self-report), vital signs, opioid consumption, side effects, day of ambulation, transition to oral analgesics will be collected from EMR until day of discharge.
- 4-week Postoperative visit: CPASS anxiety scale, cortisol level and pill count obtained on all participants.
Methods:
Statistical Analysis: Descriptive Statistics: Standard Descriptive Statistics will be used to describe the outcomes, demographic and independent variables of interest pre- and post-intervention, overall and by intervention group. Changes in outcomes will also be calculated and descried. For continuous variables means, medians and ranges will be produced, while frequencies and percentages will be produced for categorical variables. Means, standard deviations, medians and ranges will be computed for measured continuous variables; marginal distributions will be used for categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used in order to understand aspects of data quantity and examine assumptions (such as normality) underlying statistical models.
The primary outcome is decrease in opioid consumption as well as reported pain and anxiety scores. We will compare difference in pain pre- to post- between the two intervention and control groups, using ANOVA. Since data will be collected at multiple points pre- and post-intervention, and some randomly missing data expected, the primary analysis will employ generalized estimating equations (GEEs). The GEEs models will be adjusted for baseline characteristics, such as age, gender, race and any important clinical characteristics. GEEs will also be used to compare the changes in reported pain and analgesic use between the three groups.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Hypnosis Therapy, Healing Touch Therapy
- Keywords
- Complementary therapies, Hypnosis, Healing Touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis TherapyOther
A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness
Healing Touch TherapyOther
Healing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Group | Active comparator | Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol Receives: Other: Hypnosis Therapy |
| Healing Touch Group | Active comparator | Healing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol Receives: Other: Healing Touch Therapy |
| Control Group | No intervention | Control Group: ten participants will receive standard postoperative pain management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain (Total Opioid Use)
Total Opioid use will be measured in mg/kg/hour daily until discharge, and at postoperative follow-up visit. Postoperative time in PACU starts on admission to PACU until discharged to general nursing care floors. Postoperative Day #0 (POD #0) start on the day of surgery from the time the patient is discharged from the PACU to 7:00 AM the following morning. POD #1 is from 07:00 the day after surgery to the following morning (24 hour period) at 07:00. POD #2, POD #3 are the following 24 hour periods until time of discharge. The first outpatient postoperative appointment was four weeks after surgery.
Measured: up to postoperative day 4
Secondary outcomes (3)
Pain Score
Average pain score utilizing Visual Analog Scale which is a self report pain scale from 0 - 10 with a score of "0" indicating no report of pain and a score of "10" indicating the worst pain imaginable.
Measured: up to postoperative day 4
Cortisol Level
Cortisol levels obtained at 4 points - pre-operative surgical evaluation visit, intra-operative, POD #2, 4-week postoperative follow-up clinic visit. Cortisol is a hormone released by the adrenal glands. Cortisol mainly helps regulate the body's response to stress. For most tests, the normal ranges are: 6 a.m. to 8 a.m.: 10 to 20 micrograms per deciliter (mcg/dL). Around 4 p.m.: 3 to 10 mcg/dL. Normal ranges can vary from lab to lab, time to time and person to person.
Measured: up to 4-week postoperatively
Child Pain Anxiety Symptoms Scale (CPASS)
Child Pain Anxiety Symptoms Scale (CPASS) is a validated 20-item self-report tool measuring pain anxiety in adolescents undergoing major surgical procedures and obtained on all participants at 3 points - pre-surgical evaluation, POD #2 and 4-week postoperative follow-up visit. Total score is ranged from 0-100. CPASS scores ranging from 0 to 34 indicated mild pain anxiety; 35 to 67 indicated moderate pain anxiety; 68 to 100 indicated severe pain anxiety.
Measured: up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startAug 2014
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Healing Touch Worldwide Foundation
- Responsible party
- Principal investigator, Karen Sacks, Nemours Children's Clinic
- Investigators
- Karen Sacks, MSN, PNP, Principal investigator, Nemours / A I duPont Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409615
- Sponsor's protocol ID
- KS001
- Status last verified
- Aug 2024
- First submitted
- 1 Apr 2015
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kemper KJ, Vohra S, Walls R; Task Force on Complementary and Alternative Medicine; Provisional Section on Complementary, Holistic, and Integrative Medicine. American Academy of Pediatrics. The use of complementary and alternative medicine in pediatrics. Pediatrics. 2008 Dec;122(6):1374-86. doi: 10.1542/peds.2008-2173.
PubMed 19047261Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23.
PubMed 19361005Sanders H, Davis MF, Duncan B, Meaney FJ, Haynes J, Barton LL. Use of complementary and alternative medical therapies among children with special health care needs in southern Arizona. Pediatrics. 2003 Mar;111(3):584-7. doi: 10.1542/peds.111.3.584.
PubMed 12612240Post-White J, Fitzgerald M, Hageness S, Sencer SF. Complementary and alternative medicine use in children with cancer and general and specialty pediatrics. J Pediatr Oncol Nurs. 2009 Jan-Feb;26(1):7-15. doi: 10.1177/1043454208323914. Epub 2008 Oct 20.
PubMed 18936292Hagen LE, Schneider R, Stephens D, Modrusan D, Feldman BM. Use of complementary and alternative medicine by pediatric rheumatology patients. Arthritis Rheum. 2003 Feb 15;49(1):3-6. doi: 10.1002/art.10931.
PubMed 12579587Lew MW, Kravits K, Garberoglio C, Williams AC. Use of preoperative hypnosis to reduce postoperative pain and anesthesia-related side effects. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):406-23. doi: 10.1080/00207144.2011.594737.
PubMed 21867377Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
PubMed 19255840
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
- ClinicalTrials.gov ID
- NCT02409615
- Acronym / sponsor ID
- KS001
- Conditions
- Idiopathic Scoliosis
- Keywords
- Complementary therapies, Hypnosis, Healing Touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Healing Touch Worldwide Foundation
- Study start
- Aug 2014
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 27 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 30 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).
Detailed description
Female adolescents with the diagnosis of idiopathic scoliosis requiring surgery will be approached by a member of the research team at the pre-surgical evaluation visit to participate in the study. Randomization will be done at the time of the pre-surgical visit. Microsoft Excel will be used to generate a random group assignment table to one of the following groups:
CONTROL GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery
HYPNOSIS GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion and Hypnosis intervention consisting of induction to achieve a state of focused attention with heightened receptivity for acceptable suggestions targeting relaxation, comfort and healing.
HEALING TOUCH GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery and Healing Touch intervention (Chakra Connection, Magnetic Clearing)
Protocol:
- Potential patients identified by Orthopedic surgery schedule and review of electronic medical record (EMR) for eligibility.
- Randomization of participants into group, CPASS anxiety scale and cortisol level obtained for all participants at preoperative visit.
- Day of surgery: Hypnosis intervention or Healing Touch intervention prior to surgical procedure by research staff
- Intra-operative procedure: Hypnosis participant will have taped Hypnosis script during surgical procedure; Healing Touch participant will receive one minute of intentional healing at designated time each hour by Healing Touch Practitioner. Cortisol level will be obtained on all participants.
- PACU procedure: Healing Touch intervention or Hypnosis intervention by research staff.
- POD #1 until discharge: daily Healing Touch or Hypnosis intervention by research staff
- POD # 2: CPASS anxiety scale and cortisol level obtained on all participants
- Post-op analgesic regimen: Morphine PCA > 50 kg (demand 1 mg, 10 minute lockout, basal rate 0.5 mg/hr) and Morphine PCA < 40-49 kg (demand 0.8 mg, 10 minute lockout, basal rate 0.4 mg/hr), benzodiazepine, gabapentin, ketorolac and clonidine per standard protocol for all participants.
- Pain scores (self-report), vital signs, opioid consumption, side effects, day of ambulation, transition to oral analgesics will be collected from EMR until day of discharge.
- 4-week Postoperative visit: CPASS anxiety scale, cortisol level and pill count obtained on all participants.
Methods:
Statistical Analysis: Descriptive Statistics: Standard Descriptive Statistics will be used to describe the outcomes, demographic and independent variables of interest pre- and post-intervention, overall and by intervention group. Changes in outcomes will also be calculated and descried. For continuous variables means, medians and ranges will be produced, while frequencies and percentages will be produced for categorical variables. Means, standard deviations, medians and ranges will be computed for measured continuous variables; marginal distributions will be used for categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used in order to understand aspects of data quantity and examine assumptions (such as normality) underlying statistical models.
The primary outcome is decrease in opioid consumption as well as reported pain and anxiety scores. We will compare difference in pain pre- to post- between the two intervention and control groups, using ANOVA. Since data will be collected at multiple points pre- and post-intervention, and some randomly missing data expected, the primary analysis will employ generalized estimating equations (GEEs). The GEEs models will be adjusted for baseline characteristics, such as age, gender, race and any important clinical characteristics. GEEs will also be used to compare the changes in reported pain and analgesic use between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Group | Active comparator | Other: Hypnosis TherapyHypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol |
| Healing Touch Group | Active comparator | Other: Healing Touch TherapyHealing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol |
| Control Group | No intervention | –Control Group: ten participants will receive standard postoperative pain management protocol |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Females, ages 12 - 17
- Diagnosis of idiopathic scoliosis
Key exclusion criteria (2 listed)
- Patients with chronic or severe disease conditions requiring spinal fusion surgery.
- Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.
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 |
|---|---|---|
| Hypnosis TherapyA technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness | Other | Hypnosis Group |
| Healing Touch TherapyHealing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing. | Other | Healing Touch Group |
Primary outcome
Postoperative Pain (Total Opioid Use)
Time frame: up to postoperative day 4
Total Opioid use will be measured in mg/kg/hour daily until discharge, and at postoperative follow-up visit. Postoperative time in PACU starts on admission to PACU until discharged to general nursing care floors. Postoperative Day #0 (POD #0) start on the day of surgery from the time the patient is discharged from the PACU to 7:00 AM the following morning. POD #1 is from 07:00 the day after surgery to the following morning (24 hour period) at 07:00. POD #2, POD #3 are the following 24 hour periods until time of discharge. The first outpatient postoperative appointment was four weeks after surgery.
3 secondary outcomes
Pain Score
Time frame: up to postoperative day 4
Cortisol Level
Time frame: up to 4-week postoperatively
Child Pain Anxiety Symptoms Scale (CPASS)
Time frame: up to 4 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19047261Kemper KJ, Vohra S, Walls R; Task Force on Complementary and Alternative Medicine; Provisional Section on Complementary, Holistic, and Integrative Medicine. American Academy of Pediatrics. The use of complementary and alternative medicine in pediatrics. Pediatrics. 2008 Dec;122(6):1374-86. doi: 10.1542/peds.2008-2173.
- Background: PubMed 19361005Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23.
- Background: PubMed 12612240Sanders H, Davis MF, Duncan B, Meaney FJ, Haynes J, Barton LL. Use of complementary and alternative medical therapies among children with special health care needs in southern Arizona. Pediatrics. 2003 Mar;111(3):584-7. doi: 10.1542/peds.111.3.584.
- Background: PubMed 18936292Post-White J, Fitzgerald M, Hageness S, Sencer SF. Complementary and alternative medicine use in children with cancer and general and specialty pediatrics. J Pediatr Oncol Nurs. 2009 Jan-Feb;26(1):7-15. doi: 10.1177/1043454208323914. Epub 2008 Oct 20.
- Background: PubMed 12579587Hagen LE, Schneider R, Stephens D, Modrusan D, Feldman BM. Use of complementary and alternative medicine by pediatric rheumatology patients. Arthritis Rheum. 2003 Feb 15;49(1):3-6. doi: 10.1002/art.10931.
- Background: PubMed 21867377Lew MW, Kravits K, Garberoglio C, Williams AC. Use of preoperative hypnosis to reduce postoperative pain and anesthesia-related side effects. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):406-23. doi: 10.1080/00207144.2011.594737.
- Background: PubMed 19255840Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
Related trials for Idiopathic Scoliosis
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
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.
Karen Sacks, MSN, PNP principal investigator
Nemours / A I duPont Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis Therapy and Healing Touch Therapy in people with Idiopathic Scoliosis, run by Nemours Children's Clinic at 1 site in United States.
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 2 inclusion and 2 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 27 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain (Total Opioid Use) (time frame: up to postoperative day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409615, which also lists 7 linked publications.
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 27 Aug 2024.