By Grace Galzagorry, RN MS NP, December 2009
Grace Galzagorry has over 30 years of clinical experience with substance abuse and mental health disorders, and 17 years as a member of the UCSF School of Nursing faculty. She has participated in the design and implementation of numerous clinical research trials affiliated with Stanford University School of Medicine and the University of California Schools of Nursing and Medicine. Grace created and developed the San Mateo County AIDS clinic in 1990 and the Glide Health Clinic in downtown San Francisco in 1997. She presents internationally on teaching and clinical practice models, and clinical trial outcomes.
Summary
Numerous studies have shown that EMR in our environment has a detrimental impact on health. EarthCalm undertook a pilot study to determine the impact of the Infinity Home Protection System on common Quality of Life indicators. An internet survey tool was designed using a combination of the standardized scientifically validated SF 36 Health Survey and several other qualitative research tools to assess quality of life parameters in the study population.
The EarthCalm study showed the Home Protection System significantly improved a number of Quality of Life indicators. Some were not impacted or experienced significantly enough to draw conclusions, but none of the Quality of Life indicators got worse. Respondents consistently reported improvement in their perceived level of energy as well as decreased stress, fatigue and improved sleep.
Other body symptoms such as body aches, pain, numbness and tingling in extremities, cardiac irregularities, gastrointestinal distress and skin rashes also showed overall improvement. The significant improvements in mental health issues and mood indicators such as feelings of elation, focus and concentration, serenity and calmness also point to some of the more subtle symptoms of chronic microwave radiation stress on the body’s nervous system which adversely impacts these health indicators. These outcomes lend striking support to the claim that the Earthcalm Home Protection System positively impacts calmness and alleviates stress in the home environment, which may allow the body to heal itself of chronic stress and neurological disorders.
Background
A pilot research study using selected scientifically validated qualitative research tools, specifically components of the SF-36 Quality of Life survey tool, the HIT-6 (headache impact test), Mood Indicator tool, Pain Intensity VAS (visual analog score) and Sleep Quantitative Index tools were combined into one questionnaire which was administered to all clients who indicated an interest in completing the questionnaire. A month after purchasing the Home Protection System, the same respondents completed the very same questionnaire. The SF Form 36 is a commonly used, scientifically validated qualitative research tool to evaluate Quality of Life parameters. It is a multi-purpose, short-form health survey that can be used with or without biologic markers. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.
Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. Its internal reliability and validity have been established after rigorous scientific review. It is designed to assess numerous quality of life indicators such as stress, fatigue, anxiety, pain, dizziness etc.
Translations of the SF-36 have been the subject of more than 500 publications involving investigators in 22 countries. Ten or more studies have been published from 13 countries.
In addition to the SF-36, several more in depth tools were used to assess specific symptoms associated with electrosensitivity to elucidate whether participants received benefit from the product being tested. These tools included the HIT-6 (headache impact test), the Sleep Qualitative Index Study tool and the Mood Assessment Indicator tool.
The HIT-6 has good reliability and validity for measuring patients’ subjective experience and the impact of headaches on health related Quality of Life. The MOS Sleep Qualitative Index Scale was originally developed in the context of the Medical Outcomes Study (MOS). It was intended to assess the extent of sleep problems, since disturbed sleep has a major impact on quality of life and is often a common symptom of many other chronic conditions, such as chronic pain and mood disorders.
The Mood Indicator tool (PHQ9P) was developed by Quality of Life researchers and has been used extensively for assessing and categorizing mental health issues and for diagnostic purposes.
The study design was developed and overseen by Grace Galzagorry ANP MSN, Associate Clinical professor at UCSF and administered by Earthcalm personnel to study participants via internet. It was intended as an initial pilot study to systematically assess the more challenging aspects of qualitative markers in one’s life which may or may not have biologic equivalents and that are often associated with electrosensitivity. Electrosensitivity is a complex of symptoms rather than one single symptom complex and affects the body’s energetic field in a myriad of ways making its study admittedly more challenging, especially by biologic means exclusively.
The purpose of this study was to collect data about the exact symptoms that may or may not improve using the Home Protection System. While self selection bias is apparent in this study design, it is our intention to progress using the data obtained to develop more sophisticated and topic appropriate research methodologies.
Methodology
Fifteen subjects were recruited. Recruitment criteria included that the participant had just purchased a Home Protection System and was wiling to fill out the questionnaire. Study participants were rewarded with an Eco-tec upon completion of the second questionnaire one month later. No other factors in their environment were controlled for in any way by participation in the study. Standard exposure to the EMF environment was assumed and no attempt was made to alter the EMF environment in the home.
All EARTHCALM clients purchasing a Home Protection System within a six month period were sent a letter via internet introducing the study participation option and those who chose to participate completed the first questionnaire. All survey participants were given a 3-page survey to complete with instructions included on the survey instrument itself. No other contact occurred between EARTHCALM personnel and study participants.
The study author had no contact whatsoever with the study participants at any time during the trial period. Survey results were sent to the author via internet and the results were tabulated. Given the pilot study format for this study, no attempt was made to ensure double blinding or control for any other variables.
Fifteen participants total completed both questionnaires and were therefore included in the study. No one was excluded due to incomplete results as all study participants understood the survey tool and completed the survey accurately. Study participants ranged in age from 20-76 yrs of age with 55 as the median age. Four of the participants were male and eleven were female. Three of the study participants self identified as being electrosensitive, which is the main target audience for Earthcalm products, although 12/15 participants also indicated concerns about the issue of electromagnetic radiation in the environment, pointing to the general population’s concerns about this issue.
Results and Discussion
The following table summarizes the results found in this study. The final analysis excluded the following symptoms because less than half of the study participants reported having a problem with these symptoms: skin is bluish in color, blurred vision, wheezing, anxiety, seizures and abdominal pain. Of note, while anxiety wasn’t self reported as being an issue earlier in the survey, more than half the study participants reported having terror and panic attacks which responded favorably to the study intervention.
Therefore, one could conclude that anxiety, in its numerous manifestations, is a significant parameter to continue studying. The significance of the remainder of these symptoms, both for the purposes of this study as well as for any further research on Earthcalm products, will be considered negligible and will not be further studied. All other symptoms were experienced by half or more of the respondents. All symptoms are based on 0 = not experiencing symptom to 10 = severely experiencing symptom. The intervention consisted of implementing the use of the Home Protection System in the home for 30 days.
MUSCULO-SKELETAL
Symptom Total no. of participants with symptom Average severity before (scale 0-10)
Average severity after (scale 0-10)
Muscle aches 12/15 4.08 3.1
Weakness 11/15 4.9 3.5
Painful joints 12/15 5.9 3.25
NERVOUS SYSTEM/MENTAL HEALTH
Numbness/tingling of legs & feet 12/15 2.2 0.8
Dizziness 12/15 2.5 2.2
Difficulty concentrating 13/15 5.5 4.1
Depression 14/15 3.5 2.2
Little interest or pleasure in doing things 13/15 4.2 2.8
Memory loss 11/15 4.2 2.9
Feeling tired or having little energy 15/15 5.4 4.4
Feeling tense or keyed up 14/15 5.2 3.5
Spells of terror or panic 11/15 3.5 1.1
CARDIO/RESPIRATORY
Heart palpitations 10/15 3.6 2.6
Chest pain 8/15 4.0 2.5
GASTROINTESTINAL SYMPTOMS
Total number having symptom Severity before
(scale 1-10) Severity after (scale 0-10)
nausea 8/15 3.1 1.7
Gas/bloating 14/15 3.7 2.9
PAIN
Degree of pain 14/15 4.8 3.7
Pain interferes with ADL’s 14/15 4.9 3.7
Highlighted items indicate symptoms with 10% or greater improvement during the one month trial period.
The HIT-6, headache impact tool showed a total before score of 60 and after score of 58 with headache intensity over 50 indicating participants needed to seek medical attention for their headaches. A total of 13 respondents reported headaches of varying intensity.
The mood indicator tool results are conversely related to improvement. So a score of 0 = not at all and a score of 10 indicates extremely so.
SYMPTOM BEFORE AFTER
I feel calm, serene 3.8 5.8
I feel elated 2.4 4.5
I feel keen, full of energy 3.4 4.9
I feel stressed 4.7 3.5
I feel rushed, pressured 4.4 3.4
*Highlights indicate an improvement of greater than 15% in the one month trial period.
Sleep findings are summarized in the table below:
1. Need to nap during the day
BEFORE AFTER
Never/seldom 11 12
Frequently/always 4 3
2. Difficulty falling asleep
BEFORE AFTER
Never/seldom 9 11
Frequently/always 6 4
3. Difficulty staying asleep
BEFORE AFTER
Never/seldom 6 10
Frequently/always 9 5
4. Waking up feeling tired
BEFORE AFTER
Never/seldom 5 9
Frequently/always 9 6
5. Waking up early in the AM
BEFORE AFTER
Never/seldom 5 9
Frequently/always 10 6
The trends here indicate an improvement in overall sleep patterns that could be strengthened in future studies on this extremely important Quality of Life indicator.
Conclusions
The results of this pilot study show definitive improvement in some quality of life indicators and dramatic improvement in some parameters especially those parameters having to do with mood and relaxation of chronic nervous system stress. The underlying strategy in pilot studies is to cast a large net without bias to collect data systematically in order to determine the benefits, if any, of the study intervention. Despite the obvious self selection bias in the study design, that objective was met and perhaps even exceeded. Some of the noteworthy findings are:
Nervous system symptoms such as neuropathy improved by 15%,
GI symptoms probably related to nervous system issues improved by 10-15%
Mood issues such as feeling elated, serene and calm improved by 20%
Mental health symptoms such as depression and stress improved by 10%
Symptoms of stress, fatigue and feeling tired improved by 10%
Many of the clinical health issues addressed through the Quality of Life tool assessments occur at a very high rate in our Western culture so any intervention that might ameliorate these symptoms would be well worth considering. Given that an improvement was seen in almost all parameters, it could be attributed to placebo effect although many variables are hard to control for in this study environment. However, the dramatic improvement in some of the study parameters, most notably around mental health and mood issues, would certainly invite further study using a control group.
The positive outcomes of this pilot study pave the way for further scientific investigation of EarthCalm products. A model using a combination of Quality of Life indicators plus some reliable physiologic markers designed to measure stress responses in the body might be an interesting avenue. Quality of Life indicators such as sleep, pain, fatigue, mood and stress symptoms have historically been more challenging to assess and to address in the clinical arena but nothing impacts quality of life more than these symptoms. Therefore, any intervention that positively impacts these issues, even in a selected group of participants, is noteworthy and certainly warrants further investigation.