Trial Outcomes & Findings for Complementary Therapies in Spinal Fusion Patients (NCT NCT02409615)
NCT ID: NCT02409615
Last Updated: 2024-08-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
up to postoperative day 4
Results posted on
2024-08-27
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
Control Group
Control Group; ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hypnosis Group
n=10 Participants
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
|
Healing Touch Group
n=10 Participants
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.
|
Control Group
n=10 Participants
Control Group; ten participants will receive standard postoperative pain management protocol
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.37 • n=10 Participants
|
15.0 years
STANDARD_DEVIATION 1.7 • n=10 Participants
|
13.9 years
STANDARD_DEVIATION 0.74 • n=10 Participants
|
14.67 years
STANDARD_DEVIATION 1.4 • n=30 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Cobb Angle
|
53.9 degrees
STANDARD_DEVIATION 7.23 • n=10 Participants
|
54.9 degrees
STANDARD_DEVIATION 1.65 • n=10 Participants
|
57.5 degrees
STANDARD_DEVIATION 11.64 • n=10 Participants
|
55.43 degrees
STANDARD_DEVIATION 8.31 • n=30 Participants
|
PRIMARY outcome
Timeframe: up to postoperative day 4Population: opioid comsumption calculated in morphine equivalents - mg/kg/hour
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.
Outcome measures
| Measure |
Hypnosis Group
n=10 Participants
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
|
Healing Touch Group
n=9 Participants
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.
|
Control Group
n=10 Participants
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Postoperative Pain (Total Opioid Use)
PACU opioid use
|
0.041 mg/kg/hr
Interval 0.022 to 0.061
|
0.048 mg/kg/hr
Interval 0.024 to 0.072
|
0.054 mg/kg/hr
Interval 0.027 to 0.08
|
|
Postoperative Pain (Total Opioid Use)
Postoperative Day 0
|
0.038 mg/kg/hr
Interval 0.029 to 0.047
|
0.042 mg/kg/hr
Interval 0.029 to 0.054
|
0.042 mg/kg/hr
Interval 0.029 to 0.054
|
|
Postoperative Pain (Total Opioid Use)
Postoperative Day 1
|
0.019 mg/kg/hr
Interval 0.015 to 0.024
|
0.023 mg/kg/hr
Interval 0.016 to 0.031
|
0.021 mg/kg/hr
Interval 0.015 to 0.027
|
|
Postoperative Pain (Total Opioid Use)
Postopertive Day 2
|
0.012 mg/kg/hr
Interval 0.009 to 0.016
|
0.017 mg/kg/hr
Interval 0.01 to 0.024
|
0.012 mg/kg/hr
Interval 0.009 to 0.016
|
|
Postoperative Pain (Total Opioid Use)
Postoperative Day 3
|
0.012 mg/kg/hr
Interval 0.009 to 0.015
|
0.011 mg/kg/hr
Interval 0.006 to 0.017
|
0.011 mg/kg/hr
Interval 0.005 to 0.018
|
|
Postoperative Pain (Total Opioid Use)
Postoperative Day 4
|
0.02 mg/kg/hr
Interval 0.0 to 0.02
|
0.016 mg/kg/hr
Interval -0.111 to 0.143
|
0.014 mg/kg/hr
Interval -0.002 to 0.029
|
SECONDARY outcome
Timeframe: up to postoperative day 4Population: One participant was withdrawn from the study. Day of discharge varied among participants
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.
Outcome measures
| Measure |
Hypnosis Group
n=9 Participants
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
|
Healing Touch Group
n=10 Participants
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.
|
Control Group
n=10 Participants
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Pain Score
Pain Score - POD #2
|
5.56 numeric pain score
Standard Deviation 1.48
|
5.0 numeric pain score
Standard Deviation 1.7
|
5.0 numeric pain score
Standard Deviation 1.3
|
|
Pain Score
Pain score - preoperative
|
0.11 numeric pain score
Standard Deviation 0.33
|
0.5 numeric pain score
Standard Deviation 1.58
|
1.5 numeric pain score
Standard Deviation 2.27
|
|
Pain Score
Pain Score - PACU
|
5.0 numeric pain score
Standard Deviation 2.24
|
4.7 numeric pain score
Standard Deviation 3.58
|
6.2 numeric pain score
Standard Deviation 1.98
|
|
Pain Score
Pain Score - POD #0
|
5.2 numeric pain score
Standard Deviation 1.97
|
5.18 numeric pain score
Standard Deviation 2.17
|
5.36 numeric pain score
Standard Deviation 2.0
|
|
Pain Score
Pain Score - POD #1
|
4.78 numeric pain score
Standard Deviation 1.69
|
4.70 numeric pain score
Standard Deviation 1.99
|
4.33 numeric pain score
Standard Deviation 1.73
|
|
Pain Score
Pain Score - POD #3
|
7.12 numeric pain score
Standard Deviation 1.46
|
5.8 numeric pain score
Standard Deviation 2.15
|
7.8 numeric pain score
Standard Deviation 1.64
|
|
Pain Score
Pain Score - POD #4
|
4.0 numeric pain score
Standard Deviation 0
|
5.8 numeric pain score
Standard Deviation 1.34
|
4.5 numeric pain score
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: up to 4-week postoperativelyCortisol 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.
Outcome measures
| Measure |
Hypnosis Group
n=10 Participants
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
|
Healing Touch Group
n=9 Participants
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.
|
Control Group
n=10 Participants
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Cortisol Level
Preoperative coristol level
|
4.36 mcg/dL
Standard Deviation 1.88
|
6.07 mcg/dL
Standard Deviation 2.39
|
5.03 mcg/dL
Standard Deviation 1.34
|
|
Cortisol Level
Intraoperative cortisol level
|
2.94 mcg/dL
Standard Deviation 2.95
|
3.28 mcg/dL
Standard Deviation 3.67
|
3.25 mcg/dL
Standard Deviation 4.75
|
|
Cortisol Level
POD #2 cortisol level
|
7.82 mcg/dL
Standard Deviation 3.71
|
3.80 mcg/dL
Standard Deviation 2.48
|
9.07 mcg/dL
Standard Deviation 11.55
|
|
Cortisol Level
Four week postoperative cortisol level
|
6.09 mcg/dL
Standard Deviation 2.54
|
8.2 mcg/dL
Standard Deviation 3.2
|
6.05 mcg/dL
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: up to 4 weeks postoperativelyChild 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.
Outcome measures
| Measure |
Hypnosis Group
n=10 Participants
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
|
Healing Touch Group
n=9 Participants
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.
|
Control Group
n=10 Participants
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Child Pain Anxiety Symptoms Scale (CPASS)
Preoperative CPASS score
|
19.6 units on a scale
Standard Deviation 10.32
|
18.0 units on a scale
Standard Deviation 11.44
|
30.3 units on a scale
Standard Deviation 13.58
|
|
Child Pain Anxiety Symptoms Scale (CPASS)
POD #2 CPASS score
|
41.7 units on a scale
Standard Deviation 23.92
|
41.33 units on a scale
Standard Deviation 26.63
|
48.6 units on a scale
Standard Deviation 11.39
|
|
Child Pain Anxiety Symptoms Scale (CPASS)
Four week postoperative CPASS score
|
21.1 units on a scale
Standard Deviation 16.07
|
15.0 units on a scale
Standard Deviation 9.72
|
36.89 units on a scale
Standard Deviation 16.22
|
Adverse Events
Healing Touch Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Hypnosis Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healing Touch Group
n=10 participants at risk
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.
|
Hypnosis Group
n=10 participants at risk
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
|
Control Group
n=10 participants at risk
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
|
Reproductive system and breast disorders
somnolence
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
Other adverse events
| Measure |
Healing Touch Group
n=10 participants at risk
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.
|
Hypnosis Group
n=10 participants at risk
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
|
Control Group
n=10 participants at risk
Control Group: ten participants will receive standard postoperative pain management protocol
|
|---|---|---|---|
|
Nervous system disorders
Somnulence
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
Additional Information
Karen Sacks, MSN PNP
Nemours/A I duPont Hospital for Children
Phone: 302-651-5649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place