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Starlight Therapy in Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716999
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Shelley Sandblom, Nova Scotia Health Authority

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 Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Palliative Care Population
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




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. [ Time Frame: 2 hours of Starlight Therapy ]
    Edmonton Assessment scale questionnaire will be completed before Starlight Therapy and after 2 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716999


Contacts
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Contact: shelley A sandblom, BA, BScN, RN 902-449-6110 shelley.sandblom@nshealth.ca
Contact: Cynthia Stockman, BScN, MN 902-473-7776 cynthia.stockman@nshealth.ca

Locations
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Canada, Nova Scotia
Victoria General Hospital
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Nova Scotia Health Authority

Additional Information:
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

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Responsible Party: Shelley Sandblom, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03716999    
Other Study ID Numbers: Starlight Trial
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shelley Sandblom, Nova Scotia Health Authority:
palliative
starlight
end-of-life symptoms
non-pharmacological