Starlight Therapy in Palliative Care

• Sponsor: Nova Scotia Health Authority (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03716999
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 33.4
• Patients Per Site Per Month: 3

Study Details

Study Description

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 using a mixed-method analysis.

Condition or Disease	Intervention/Treatment	Phase
Symptom Management	Other: Starlight Therapy

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.

Three 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 of Starlight Therapy as a Non-Pharmacological Nursing Intervention for Palliative Care Patients".

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care
• Anticipated Study Start Date: Feb 15, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Palliative Care Patients Palliative care Patients meeting criteria will receive Starlight Therapy	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

Outcome Measures

Primary Outcome Measures

1. 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. [2 hours of Starlight Therapy]

   Edmonton Assessment scale questionnaire will be completed before Starlight Therapy and after 2 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Victoria General Hospital	Halifax	Nova Scotia	Canada

Sponsors and Collaborators

• Nova Scotia Health Authority

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Quantitative study on Starlight Therapy

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

• Responsible Party: Shelley Sandblom, Principal Investigator, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT03716999
• Other Study ID Numbers: Starlight Trial
• First Posted: Oct 23, 2018
• Last Update Posted: Feb 1, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shelley Sandblom, Principal Investigator, Nova Scotia Health Authority: palliative; starlight; end-of-life symptoms; non-pharmacological

Study Results

No Results Posted as of Feb 1, 2021