Effectiveness Not Established

Cranial Stimulation

for Anxiety

Cranial stimulation is a complementary medicine intervention that provides electrical stimulation to the brain. Cranial electrical stimulation studied in patients with cancer was delivered via a medical device that delivered a programmed level of electrical stimulation via electrodes attached to the earlobes with a low intensity delivered from a battery source. This intervention was studied in patients with cancer for its effect on fatigue and sleep/wake disturbance.

Research Evidence Summaries

Lyon, D., Kelly, D., Walter, J., Bear, H., Thacker, L., & Elswick, R.K. (2015). Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus, 4, 369-015-1151-z. 

Study Purpose

To examine the effects of cranial stimulation on symptoms

Intervention Characteristics/Basic Study Process

Women were randomly assigned to receive actual or sham cranial stimulation. The device passed biphasic electrical stimulation via ear lobe electrodes. The active device was preset to deliver maximum stimulation at 0.5 Hz and 100 µA, the lowest setting below the level of perception. The sham device was identical but did not transmit a current. Patients were instructed to use the device daily for one hour during chemotherapy treatment and for two weeks after treatment cessation. Symptom data were collected weekly, and patients completed logs to record stimulator use.

Sample Characteristics

  • N = 163
  • MEAN AGE = 51 years (SD = 0.78 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All participants had breast cancer, and 88.3% had stage 2 disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: In total, 61.7% were Caucasian, and 82% had more than a high school education.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Florida

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care

Study Design

Double-blinded, randomized, sham-controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)
  • Brief Fatigue Inventory (BFI) 
  • General Sleep Disturbance Scale (GSDS)

Results

There were no statistically significant differences in levels of depression, anxiety, pain, fatigue, or sleep at any time point during the study. Symptom levels were low. Anxiety was highest at baseline and decreased over time. Depression and fatigue increased over time.

Conclusions

This study did not demonstrate any benefit of microcurrent cranial stimulation in the management of pain, anxiety, depression, fatigue, or sleep disturbance among women receiving chemotherapy for breast cancer.

Limitations

  • The patients had low symptom severity, which may have caused the lack of significant changes.
  • Adherence to the intervention was measured by patient self-reports.

Nursing Implications

Cranial stimulation did not benefit symptom management in this study.

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