Starlight Therapy in Palliative Care

January 11, 2023 updated by: Shelley Sandblom, Nova Scotia Health Authority

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

Not yet recruiting

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Victoria General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in an inpatient palliative care Setting who meet the specified criteria for inclusion in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2023

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

November 30, 2025

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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