Cancer, Environmental Factor, Neoplasms, Non-invasive Intervention, Non-pharmacological Intervention, Sleep Initiation and Maintenance Disorders, Sleep Quality, Supportive Intervention
Conditions
Keywords
electrical grounding, earthing, body voltage, electromagnetic field, bedroom environment, insomnia, Pittsburgh Sleep Quality Index, oncology inpatients, sham-controlled
Brief summary
Sleep disturbance is one of the most common and most persistent symptoms in patients admitted for cancer care, and the options available during a short hospital stay are limited. The human body is electrically conductive, so an alternating potential - known as body voltage - is induced on the skin by mains wiring and appliances near the bed. Body voltage can be lowered by connecting the body to earth, and higher body voltage has been reported to be associated with lower vagal (parasympathetic) tone. This randomised, sham-controlled trial tested whether nightly electrical grounding improves sleep quality in hospitalised patients with cancer who also have clinically significant insomnia. Participants wore a hydrogel patch on the forehead connected by a cord either to a true earth connection or to an externally identical cord that did not complete a conductive circuit. Grounding was applied on two consecutive nights in the oncology ward and then nightly at home until the outpatient follow-up visit. Body voltage was measured before and during grounding in both settings, so that the trial could verify objectively whether the intervention achieved its intended physical effect. Sleep quality, mood, somatic symptoms and daytime sleepiness were assessed by validated self-report questionnaires.
Detailed description
Design. Prospective, randomised, sham-controlled, participant-blinded, parallel two-group trial conducted in the oncology ward of New Taipei Municipal TuCheng Hospital. Allocation. Participants were allocated to true grounding or sham grounding by a randomised block design generated with the Research Randomizer web service. The true and sham cords were externally indistinguishable, differing only in whether a conductive connection was completed internally; participants were therefore blinded to allocation. Investigators who applied the intervention and measured body voltage were necessarily aware of allocation. Intervention. Grounding was delivered through a medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a grounding cord, with the impedance of the completed circuit limited to less than 100 ohms. In hospital the cord was connected to the earth terminal of the bedside mains outlet; at home it was connected to a metal window frame, because domestic outlets in Taiwan do not reliably provide a standard earth terminal. Grounding was applied from 21:00 to 06:00 on two consecutive nights in the ward, suspended until discharge, and then applied nightly at home for at least six hours until the outpatient follow-up visit. Body voltage. The alternating potential at the fingertip was measured with a digital multimeter while the participant lay in bed, both before and during grounding, on each in-hospital study night and once at home. Remote bedroom assessment. Within two days of discharge a researcher conducted a video call to record the electromagnetic environment of the bedroom using a purpose-designed questionnaire, and to teach the participant to measure body voltage and to ground safely at home. Statistical analysis. The primary between-group treatment effect was estimated by analysis of covariance, regressing each follow-up score on allocation arm with the corresponding baseline score as covariate. Every model was repeated on rank-transformed data as a sensitivity analysis. All tests were two-sided at the 5% level.
Interventions
A Medical-grade hydrogel conductive patch ( 4 x 5 cm ) applied to the participants' forehead skin is connected by an electrically conductive cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the hospital ward and then nightly at home for at least six hours for 7 days before the outpatient follow-up visit. Assigned Intervention Device: true Electrical grounding patch
Medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a sham-grounding cord (not conductively connected ) to an earth connection point. Assigned Intervention Device: sham-grounding cord
Sponsors
Study design
Eligibility
Inclusion criteria
* Inpatients of the oncology ward aged 20 to 79 years * Subjective complaint of insomnia, with a Pittsburgh Sleep Quality Index global score of 10 or greater at baseline * Histologically or clinically confirmed cancer of any stage from 0 to IV * Intact forehead skin permitting application of a grounding patch * Scheduled hospital admission of more than three days * Able and willing to give written informed consent
Exclusion criteria
* Baseline Pittsburgh Sleep Quality Index global score of 9 or less * Known or suspected pregnancy * History of alcohol dependence with less than two months of abstinence * Recent use of an indoor grounding product during sleep for more than one month * Habitually walking barefoot outdoors for more than one hour a day for more than one month * Unable or unwilling to complete the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PSQI scores | first: Baseline (before the first study night) second: the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge | The PSQI is a 19-item self-report instrument assessing sleep quality over the preceding month. It yields a global score ranging from 0 to 21, obtained by summing seven component scores each rated 0 to 3. Higher scores indicate poorer sleep quality. |
| Change in Pittsburgh Sleep Quality Index (PSQI) component scores | Baseline (before the first study night) and the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge | Seven components of the PSQI, each scored 0 to 3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher scores indicate poorer sleep. |
| Leeds Sleep Evaluation Questionnaire (SEQ) domain scores | Morning after the first in-hospital study night, morning after the second in-hospital study night, and the outpatient follow-up visit 7 to 14 days after discharge | Self-rated change in sleep attributable to treatment, across four domains: getting to sleep, quality of sleep, awake following sleep, and behaviour following wakening. Each domain is scored on visual analogue scales; higher scores indicate better sleep. The instrument asks the respondent to compare current sleep with the period before treatment and therefore has no pre-treatment value. |
| Body voltage at the fingertip | Once at first enrollment (on the day before two in-hospital study nights), and once in the participant's own bedroom within 2 days of hospital discharge | Alternating-current potential in volts, measured with a digital multimeter at the fingertip while the participant lies in bed, recorded immediately before and during grounding. Lower values indicate less induced electrical potential on the body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) score | Baseline and the outpatient follow-up visit 7 to 14 days after discharge | Chinese version of the HADS. Anxiety and depression subscales each range from 0 to 21 and the total score from 0 to 42. Higher scores indicate greater distress. |
| Change in Depression and Somatic Symptoms Scale (DSSS) score | Baseline and the outpatient follow-up visit 7 to 14 days after discharge | Chinese version of the DSSS, assessing depressive and somatic symptoms. Higher scores indicate more severe symptoms. |
| Change in Karolinska Sleepiness Scale (KSS) daily total | Baseline, the mornings following each of the two in-hospital study nights, and the outpatient follow-up visit 7 to 14 days after discharge | Subjective sleepiness rated on a 9-point scale in the morning, afternoon and evening and summed to a daily total ranging from 3 to 27. Higher scores indicate greater sleepiness. |
Countries
Taiwan
Contacts
New Taipei City Municipal TuCheng Hospital