Starlight Therapy in Palliative Care

Symptom Management Clinical Trial

Official title:

Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716999
• Other study ID #: Starlight Trial
• Status: Not yet recruiting
• Start date: December 15, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2023
• Source: Nova Scotia Health Authority
• Contact: shelley A sandblom, BA, BScN, RN
• Phone: 902-449-6110
• Email: shelley.sandblom[@]nshealth.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Symptom Management

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Victoria General Hospital	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Edmonton Assessment scale questionnaire will be completed before Starlight Therapy and after 2 hours.	2 hours of Starlight Therapy

External Links

•   Quantitative study on Starlight Therapy