- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716999
Starlight Therapy in Palliative Care
Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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".
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: shelley A sandblom, BA, BScN, RN
- Phone Number: 902-449-6110
- Email: shelley.sandblom@nshealth.ca
Study Locations
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-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Victoria General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1. ESAS indicates at least one of the following symptoms:
- Insomnia
- Anxiety
- Restlessness
- Dyspnea
- Pain
Exclusion Criteria:
- Clinical Diagnosis of blindness
ESAS does not include any of the flowing symptoms:
- Insomnia
- Anxiety
- Restlessness
- Dyspnea
- Pain
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Palliative Care Patients
Palliative care Patients meeting criteria will receive Starlight Therapy
|
Starlight Projector will be placed in patients' rooms and project starlight on the ceilings and walls in an effort to reduce unpleasant symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 2 hours of Starlight Therapy
|
Edmonton Assessment scale questionnaire will be completed before Starlight Therapy and after 2 hours.
|
2 hours of Starlight Therapy
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Starlight Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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