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| Name | Class |
|---|---|
| Healing Touch Worldwide Foundation | OTHER |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis Group | Active Comparator | Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol |
|
| Healing Touch Group | Active Comparator | Healing 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis Therapy | Other | A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to postoperative day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to postoperative day 4 |
| Cortisol Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sacks, MSN, PNP | Nemours / A I duPont Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours / A I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19047261 | Background | 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. | |
| 19361005 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypnosis Group | Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol Hypnosis Therapy: A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness |
| FG001 | Healing Touch Group | Healing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol Healing Touch Therapy: 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. |
| FG002 | Control Group | Control Group; ten participants will receive standard postoperative pain management protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnosis Group | Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol Hypnosis Therapy: A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | opioid comsumption calculated in morphine equivalents - mg/kg/hour | Posted | Mean | 95% Confidence Interval | mg/kg/hr | up to postoperative day 4 |
|
Postoperative Day #0 up to POD #1
Participant assigned to Healing Touch Group, somnolent postoperative day #0, transferred to PICU for closer monitoring, withdrawn from study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healing Touch Group | Healing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol Healing Touch Therapy: Healing Touch An energy 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Non-systematic Assessment | Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnulence | Nervous system disorders | Standard terminology | Non-systematic Assessment | Participant becoming somnolent on standard weight based dosing of opioid medication, transferred to the PICU for closer monitoring. Withdrawn from study due to transfer to ICU. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sacks, MSN PNP | Nemours/A I duPont Hospital for Children | 302-651-5649 | ksacks@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2014 | Feb 13, 2024 | Prot_SAP_000.pdf |
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| Healing Touch Therapy | Other | 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. |
|
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. |
| 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. | up to 4 weeks postoperatively |
| Barnes 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. |
| 12612240 | Background | Sanders 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. |
| 18936292 | Background | Post-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. |
| 12579587 | Background | Hagen 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. |
| 21867377 | Background | Lew 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. |
| 19255840 | Background | Accardi 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. |
| Healing Touch Group |
Healing Touch Group: nine participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol Healing Touch Therapy: 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. |
| BG002 | Control Group | Control Group; ten participants will receive standard postoperative pain management protocol |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cobb Angle | The Cobb Angle is a measurement of bending disorders of the vertebral column such as scoliosis. The Cobb Angle is measured in degrees, with a range of 10-20 to be considered mild scoliosis. Surgical treatment is generally indicated for curves exceeding 45-50 degrees. | Mean | Standard Deviation | degrees |
|
| OG001 | Healing Touch Group | Healing Touch Group: nine participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol Healing Touch Therapy: 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. |
| OG002 | Control Group | Control Group: ten participants will receive standard postoperative pain management protocol |
|
|
| Secondary | 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. | One participant was withdrawn from the study. Day of discharge varied among participants | Posted | Mean | Standard Deviation | numeric pain score | up to postoperative day 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mcg/dL | up to 4-week postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | up to 4 weeks postoperatively |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 1 |
| 10 |
| EG001 | Hypnosis Group | Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol Hypnosis Therapy: A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Control Group | Control Group: ten participants will receive standard postoperative pain management protocol | 0 | 10 | 0 | 10 | 0 | 10 |
| somnolence | Reproductive system and breast disorders | Non-systematic Assessment | Postoperative somnolence. Participant transferred to PICU for additional monitoring. Once admitted to PICU, became ineligible and withdrawn from study |
|
|
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| Male |
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| Pain Score - PACU |
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| Pain Score - POD #0 |
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| Pain Score - POD #1 |
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| Pain Score - POD #2 |
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| Pain Score - POD #3 |
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| Pain Score - POD #4 |
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| POD #2 cortisol level |
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| Four week postoperative cortisol level |
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| Four week postoperative CPASS score |
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