Clinical trial NCT03716999: Starlight Therapy in Palliative Care
Official title: Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Symptom Management
Keywords: palliative
starlight
end-of-life symptoms
non-pharmacological
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in an inpatient palliative care Setting who meet the specified criteria for inclusion in the study

Brief summary: Starlight Therapy™ has been shown to help alleviate end-of-life symptoms in Palliative Care patients and reduce the need for PRN or "as needed" medications. This study will investigate the efficacy of this intervention on the symptom of anxiety using a mixed-method analysis.

The primary investigator hypothesizes that any anti-anxiolytic effects could be caused by the Intrinsically Photosensitive Retinal Ganglion Cell neural pathway to the amygdala.

Detailed description: Starlight Therapy has been shown (see citation) to help alleviate end-of-life symptoms in Palliative Care patients and reduce the need for PRN or "as needed" medications. This study will investigate the efficacy of this intervention using a mixed-method analysis.

Starlight Therapy will be offered to patients with unpleasant end-of-life symptoms such as dyspnea, agitation, anxiety, restlessness and insomnia. The effect the Starlight Therapy has in helping alleviate these symptoms will be measured using the ESAS (Edmonton Symptom Assessment System) questionnaire at baseline and following a predetermined period of time of Starlight Therapy.

10 Starlight Projectors have been purchased for the unit where the study will take place: the Inpatient Palliative Care Unit 7A, Victoria General Hospital, Centennial Building. The funding was acquired by a Comfort \& Care Grant from the QEII Foundation.

The results will be compiled and analyzed in a research paper "Concerning the Efficacy and Underlying Mechanism of Starlight Therapy as a Non-Pharmacological Nursing Intervention for Palliative Care Patients".

Eligibility criteria: Inclusion Criteria:

1. ESAS indicates at least one of the following symptoms:

* Insomnia
* Anxiety
* Restlessness
* Dyspnea
* Pain

Exclusion Criteria:

1. Clinical Diagnosis of blindness
2. ESAS does not include any of the flowing symptoms:

   * Insomnia
   * Anxiety
   * Restlessness
   * Dyspnea
   * Pain

Primary outcomes:
measure: Using Starlight Therapy to measure Change in Unpleasant Symptoms in Palliative Care Patients as measured using the ESAS (Edmonton Symptom Assessment System) Scale. On a scale of 0-10, with 0 = no symptom and 10= symptom is worst outcome possible.
timeFrame: 2 hours of Starlight Therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hospital
state: Nova Scotia
Study officials:
References:
citation: Evaluation of a Low-Light Intervention-Starlight Therapy-for Agitation, Anxiety, Restlessness, Sleep Disturbances, Dyspnea, and Pain at End of Life. (2017). Journal of Hospice & Palliative Nursing, 19(3), 221-222. doi:10.1097/njh.0000000000000343