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��ࡱ�>��	�����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������{�	��zVbjbjz�z�	D���9N@���������������������80<�-L�XX(���[[[�K�K�K�K�K�K�K$N��P@�K�[[[[[�K������K�$�$�$[|�����K�$[�K�$�$n(>B�����0q�w>i�������@@ �K�K0-L`@�QY 8Q@BBQ�C�[[�$[[[[[�K�K�"b[[[-L[[[[��������������������������������������������������������������������Q[[[[[[[[[� �:	The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients:  A Pilot Prospective Crossover Trial
INTRODUCTION
Optimal qualitative and quantitative sleep is an important aspect of normal human function. Healthy sleep patterns are particularly critical for any patient recovering from a traumatic infliction, such as a serious burn injury. It is known that pediatric burn patients suffer from sleep deprivation during their recovery from acute injuries and continue to experience disruptive sleep for many years post discharge.1-5
Sleep patterns, as measured by polysomnography (PSG), typically include electroencephalogram, electrooculogram and electromyogram recordings in order to distinguish light sleep and deep sleep, as well as non-rapid eye movement (NREM) sleep and rapid eye movement (REM). Sleep architecture is further categorized into four stages (i.e. stages 1, 2, and 3) plus REM. Sleep typically passes from light sleep (stages 1 and 2) to deep or restorative sleep (stages 3 and REM sleep).6
This single site feasibility pilot study assessed the effect of Healing Touch (HT), an energy based therapy, on sleep patterns of pediatric patients who were in the process of recovering from reconstructive procedures and other rehabilitative treatments relating to their burn injuries. Convalescence for this group of patients can be long and arduous, often involving multiple hospital stays that include painful diagnostic and treatment procedures, and therefore; it is essential that favorable conditions for uninterrupted healing of the whole individual are implemented.
Children with acute thermal injury experience disruptive sleep during their hospitalization with excessive light sleep (stage 1) and very little, if any, REM sleep.1,2,3,12,13,14  Furthermore, reports indicate that sleep aberrations continue many years postburn.8,15 Sleep inadequacy is associated with a heightened propensity for morbidity and mortality. On the other hand, restorative sleep is associated with enhanced immune functioning and wound repair, improvements in endocrine and glycemic measures, as well as increased pain threshold, reduced emotional stress and enhanced quality of life.
The purpose of this prospective pilot study was to examine if the use of a gentle and subtle energy therapy, HT, can improve the quantity and quality of nocturnal sleep in pediatric burn patients. This heart-centered energy based modality has been shown to benefit patients suffering from stress, pain and anxiety. The term �heart-centered� refers to the practitioner�s intentional focus to feel compassion and love in order to transmit universal healing energies, making it possible to set aside the ego and allow an outcome for the patient�s highest good. The term �subtle energy� was first used by physicist Albert Einstein to describe the minute ongoing interrelationships between subatomic particles. This energy is in continuous interaction with matter as exemplified by our physical bodies, and the speed of our thoughts augmented by our emotions and sensitivity to our highest potential.16
The practice of HT utilizes and moves Qi (energy) to create a healing experience. It involves a gentle series of movements of the practitioner�s hands either directly touching the clothed body or several inches above the recipient. HT is used to facilitate a person�s healing and restoration by bringing their physical, emotional, mental and spiritual aspects into balance by reorganizing or unblocking the chakras and soothing the energy field within and surrounding a human being. The word Chakra means �wheel� or �vortex� in the primary Hindu liturgical language called �Sanskrit�, suggesting a whirling center of human Qi. HT practitioners are taught that trauma or disease naturally results in a disruption in the patients energy flow, and that the process of affecting and reorganizing the 7 major chakras that primarily extend from their locations near the spinal column through the finer layers of the energy field, in both the front and back of the body, can restore the energy flow to balance to bring about a sense of calm, thereby aiding the healing process.16-17 (Figure 1)
HT is an energy therapy developed by Janet Mentgen,16 endorsed by the American Holistic Nurses Association, and recognized as one of a number of energy therapies by the National Center for Complementary and Alternative Medicine (NCCAM)18. Research indicates that the benefits of HT range from reduction of pain, anxiety, depression, fatigue, and stress to enhanced wound healing, immunologic functioning and overall quality of life.19-23 HT techniques utilized in influencing the patient�s energy field are non-invasive, whereby the practitioner�s hands clear, energize and balance the human and environmental fields, thus affecting health and healing.18 
METHODS
Ten patients with a history of a burn injury from an electrical, flame, scald or chemical source were enrolled in this study. (Figure 2). All were in the postoperative period of their hospitalization. Excluded from the study were patients with pre-existing neurological conditions or those who required face and head grafting if they interfered with the lead placements. After obtaining approval from our local Institutional Review Board and following completion of informed consent, assent and HIPAA release, a sleep history questionnaire was administered by the consenting investigator to identify and exclude subjects with evidence of a pre-existing sleep disorder. Parents and guardians were invited to remain in the room to observe the HT intervention. Subjects were randomized to determine the order of HT versus no HT treatment (whereby patients served as their own control) utilizing a 2-period crossover design.24 Each patient served as his own control in order to determine if HT had an impact on the patient�s sleep patterns, rather than compare HT to a different modality such as massage or hypnotherapy. The randomization scheme was generated by the study statistician and given to the Primary Investigator. Included in the study were patients (age 5 to 21 years) admitted for treatment at Shriners Hospitals for Children � Cincinnati. 
One group received HT during study day 1 and no HT during study day 2. The other group received no HT during study day 1 and HT during study day 2. Although HT was only performed on 1 night, PSG recordings were obtained during the 2 nocturnal study periods to assess and analyze sleep.   Eight channels were utilized for the PSG montage: the outer canthus of the eyes, the frontal, central and occipital scalp leads, the chin, and the bilateral ears as reference leads. PSG recordings were accomplished with the Sandman Elite Sleep System (Tyco Healthcare/Puritan Bennett Ltd, Kanata, Ontario, Canada). (Figure 2)
The Sandman Elite Sleep System provided comprehensive summary reports of sleep stages with simultaneous recordings of electroencephalography, electromyography, electrooculography, respiration, pulse oxygen saturation, and body movement activities. Subjects were connected to the montage at approximately 2100 for younger children and around 2300 for young adults who preferred a later sleep time, and PSG monitoring continued until around 0700 the following morning. Identical soft background music played at the initiation of PSG on both nights, and was left on until the 45-60 minute long music CD ended. Although a wide selection of music was used for the patients in the study, the same music played on both nights for each individual patient. The sleep technician was present for each monitoring night. 
The American Academy of Sleep Medicine�s newly released guidelines, The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications6 were used for scoring the polysomnography data. Interpretation of sleep data was performed by the Sleep Disorder Center Director (a board-certified sleep specialist) of Cincinnati Children�s Hospital Medical Center.Healing Touch was performed by two certified practitioners who utilized the same HT techniques. The practitioners practiced heart-centering exercises at the patient�s bedside before applying HT, in order to become present, connected within, focused and open to spiritual guidance. The goal in centering was for the practitioner to clear the ego in order to connect more deeply with the Higher Self, to connect to a Higher Power, and to be fully present and open to another. The practitioner�s level of awareness is a central factor in the success of the interaction and the practitioner must be relaxed and focused or �centered� on the client. Prior studies on healing energy have indicated that healers can interact with energy fields without actually touching the person they are helping to heal.20 
HT began immediately after the electrodes were properly positioned and at the commencement of PSG. The HT interventions included practitioner introduction and education of the procedure with the patient. The HT procedure involved a gentle use of the practitioner�s hands either directly touching the clothed body or several inches above the recipient. (Figure 3)
The HT procedure was comprised of three techniques. (1) Magnetic clearing to cleanse the body�s energy field to assist in releasing emotional debris and feelings of fear, anger, worry and tension. Magnetic clearing consisted of the practitioner making 15-30 full length smooth continuous passes with both hands one to six inches from the patient�s body. (2) Mind clearing was used for relaxation and to focus or quiet the mind. It consisted of the practitioner placing their hands lightly on or above a variety of sites around the head, neck, forehead and face. (3) Chakra connection technique where the practitioner�s hands were placed on the major and minor chakras of the body completed the HT session. The chakra connection is designed to connect, open and balance the energy centers and enhance the flow of energy in the body.17 The practitioner concluded the session by documenting the research procedure, noting any unexpected occurrences or observations. 
Management of all patients was supervised by the chief of staff providing uniform care in accordance with standardized clinical protocols for surgical procedures, respiratory care, nutrition support, dressings and topical agents. All data were password-protected for confidentially. The files did not contain personal identifiers and were identified using a study identification number. 

Data were managed and analyzed using SAS�, version 9.2 (SAS institute, Cary NC). Demographics are reported both as mean � standard error and median with 25th and 75th percentiles due to the sample size although these variables do not show deviation from the assumption of normality.  This is a crossover study with a sample size of 10, again due to the sample size and prior knowledge that the sleep variables can show deviation from the assumption of normality, non-parametric statistics were used for analysis of the paired difference between the HT night and the non-HT night, specifically a paired signed rank test to examine the deviation from zero.  The sleep variables analyzed were total sleep time, sleep efficiency, sleep latency, number of awakenings, minutes spent in wake after sleep onset, REM periods and the minutes and percentage of time compared to normal in each stage of sleep were used for analysis of HT versus non-HT nights and percentage of time compared to normal spent in each stage of sleep; N1, N2, N3 and REM.

 Power calculations were done using SAS PROC POWER for crossover design. The initial approach examined frequencies and univariate distributions in order to check validity of the data, checking for outlying observations and for the need for transformation of variables for the analysis. Accuracy checks were run using PROC UNIVARIATE and PROC FREQ. In addition, sleep activity was examined to determine the percent of time asleep during each of the first 7 hours on both nights; a paired t-test was used to compare HT and non-HT nights.

RESULTS
Ten patients consented to participate in the study between June 2010 and April 2012. (Figure 4) The median age at the time of the HT procedures was 15.5 years (Range: 13-20 years). All subjects were 2-3 days postoperative status when they received HT.  Three sessions were performed by one HT practitioner and 7 by the other HT practitioner. Patients were studied a mean of 7.2 � 2.0 years post burn. (Table 1) Out of 10 patients, 5 had another person (family, friend or a 2nd HT practitioner) remain in the room. All present reported that they felt relaxed during and after the HT intervention and that observing the HT process itself brought about a sense of calm. There was no difference in the medications used during both nights of the study. Two of the young adult patients ages 16 and 21 were not tired, and although both continued to use their mobile phones and receive text alerts for socialization rather than sleep after HT, they were deeply relaxed during the 45 minute HT session. 
For all 10 patients, data analysis indicated that HT had a significant effect on the quantity and quality of sleep. Total sleep time (TST) was enhanced (median 391 vs. 331 minutes, p=0.02). Furthermore, the percent of time asleep during the first seven hours increased with significant differences in sleep during the 4th, 6th and 7th hours. (Figure 5) The number of REM periods also increased in the HT group (median 4.5 vs. 3.5, p=0.03).Patients fell asleep more quickly on HT nights than on non HT nights. Sleep efficiency and N2 sleep was significantly enhanced (p<0.04 and p<0.03) and no effect was observed on number of awakenings on HT nights, or sequencing of HT intervention.
DISCUSSION 
There were significant differences in sleep over the course of the study period. HT patients fell asleep more quickly (e.g. in half the time). During the HT nights, patients slept twice as many minutes in the important restorative sleep stage 3 and spent more time in REM sleep. The purpose of this pilot study was not to compare HT to other interventions, but rather to use the subject as his own control to determine if there is a difference in sleep patterns with or without Healing Touch after a burn or a burn injury reconstructive surgery. Researchers at our facility are currently preparing a grant application to include a sham, control no presence and a control presence group.  
Because it is difficult to measure the movement of an invisible energy or QI, we used PSG to determine if in fact, the energetic exchange and activity of the practitioner could create a difference in the electric impulses from nerve activity and muscular movements. Although certified practitioners are required to demonstrate competency and possess the skills and knowledge to move Qi, there are many factors involved that can create energy blocks, for both practitioner and healee, such as fear and pain, discomfort from memories of the initial burn and the environment including the temperament of the health care providers, patient and family members.  The results indicate that the patients in this pilot study who received HT fell asleep more quickly, slept longer, and seemed less likely to react to external stimuli such as a sudden loud noise, which is not unusual in the burn hospital environment. This could be because they were in a deep state of relaxation. 

The effects of any trauma can extend beyond the physical realm, therefore affecting thoughts, behaviors and sleeping habits leading to insomnia, nightmares and difficulty relaxing. Traumatic experience activates the neurosensory apparatus, altering the pattern and quantity of neurotransmitter release throughout the neuronal systems responsible for sensation, perception and processing of that specific trauma.35 These changes affect the micro-environment of the psychophysical system, therefore altering function and cellular memory of the experience. By centering and setting an intention for the highest good of the individual, practitioners are trained to sense and re-align any disrupted minute, human subatomic particle irregularities and interrelationships within the micro-environment to restore the neurosensory apparatus to a normal state and therefore improve sleep.35 
According to the National Sleep Foundation,36 the following are common sleep problems that occur following a traumatic event:
Flashbacks and troubling thoughts that make it difficult to fall asleepA need to be on alert to prevent a re-occurrence of the traumaAnxiety and restlessness brought on by darkness and nightNightmares that cause one to wake up in the middle of the night and make it difficult to go back to sleep
It is believed that when the host is stressed or unable to express emotions, the chakras become distorted and out of alignment. When this occurs energy cannot flow freely, hence the physical body may not heal well. Chakras are balanced when the practitioner uses heart-centered energy to invite the body to return to its natural state by stimulating the senses favorably.37 
Based on the data obtained from this small study group, we have determined that Healing Touch improves abnormal sleep architecture exhibited by pediatric burn patients. Study limitations included the small sample size.  
Also problematic was the dislodgement of some of the PSG leads on one of the patients who was sweating profusely and the unwillingness of 2 patients to put aside their social activities and the use of their cellular phones. One of the patients was in a deeply relaxed sleep state when his phone rang loudly at the same time the HT intervention ended. However, patient care interruptions during the night are an expected element in the study plan.

Research on HT includes studies on the effect of the trauma release technique in reducing chronic pain, 26 the effects on percutaneous coronary intervention for unstable coronary syndromes,27 and significant changes in IgA and stress levels after HT treatment.28 Pain studies in HT include a study that showed a significant decrease in pain scores after four sessions of HT.29 Subjects also reported an increased relaxation and better overall perspective toward life.30,31 Other studies have found reduction in pain for both inpatients and outpatients in a hospital setting.32-34 Although HT has had a relatively limited track record of research, the field of energy medicine including the Chinese qigong and Indian yoga has had a long history of research and application in treating pain and other medical conditions.
It is interesting that when we compared our findings to age and gender specific norms, our results corroborated prior findings of excessive N1 and deficient N3 restorative sleep.(Table 2) It also appears that HT triggers a rapid relaxation response demonstrated by the fact that subjects entered sleep in half the time when they had HT compared to when they did not have HT. While not significant, the findings indicating a reduction in sleep stage 1 and an increase in the deeper N2 and N3 stages of sleep during the HT night are very encouraging.

Conclusion
HT was associated with significant improvement in total sleep time. HT patients fell asleep more quickly and also slept an extra hour on HT nights compared with non-HT nights. The percent of time asleep increased incrementally during the first seven hours, and more periods of REM sleep were observed. Significant improvements in sleep efficiency occurred. Furthermore, sleep latency was reduced with clinical improvements in N1 and N3 sleep stages although statistical significance was not achieved. HT appears to benefit the quantity and quality of restorative sleep in pediatric burn patients during the rehabilitative phase of recovery. Achieving adequate sleep continues to be a problem post burn and the plan is to continue to monitor the effect of HT on the sleep activities of many more pediatric burn survivors. 
















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