NCT03716999

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Dec 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
8.2 years until next milestone

Study Start

First participant enrolled

December 15, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

August 23, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

October 18, 2018

Last Update Submit

August 21, 2024

Conditions

Keywords

palliativestarlightend-of-life symptomsnon-pharmacological

Outcome Measures

Primary Outcomes (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.

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

    2 hours of Starlight Therapy

Study Arms (1)

Palliative Care Patients

Palliative care Patients meeting criteria will receive Starlight Therapy

Other: Starlight Therapy

Interventions

Starlight Projector will be placed in patients' rooms and project starlight on the ceilings and walls in an effort to reduce unpleasant symptoms

Palliative Care Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. ESAS indicates at least one of the following symptoms:
  • Insomnia
  • Anxiety
  • Restlessness
  • Dyspnea
  • Pain

You may not qualify if:

  • Clinical Diagnosis of blindness
  • ESAS does not include any of the flowing symptoms:
  • Insomnia
  • Anxiety
  • Restlessness
  • Dyspnea
  • Pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria General Hospital

Halifax, Nova Scotia, Canada

Location

Related 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

    BACKGROUND

Related Links

Central Study Contacts

shelley A sandblom, BA, BScN, RN

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 23, 2018

Study Start (Estimated)

December 15, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

August 23, 2024

Record last verified: 2024-02

Locations