The Sunlight Exposure Therapy on the Improvement of Depression and Quality of Life in Post-stroke Patients

NCT04036565 | Completed

• 1 other identifier: 2017-09-001CC
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic diseases has been the leading causes of death in 2015 to 2017 based on the National database. In particular, cerebrovascular disease was the third in 2015, the fourth in 2016 and 2017. In the Statistical Office of the Ministry of Health and Welfare (2016, 2017,2018). Previous studies have suggested that nearly 30% of the stroke victims present with signs of depression within the first 5 years of illness. Since post-stroke depression significantly affects the patient both physically and psychologically, the emotional disturbances impede the progress and effectiveness of rehabilitation. Regarding the non-pharmacological treatment of melancholia, the phototherapy has been used to treat psychological, behavioral or emotional disorders with satisfactory outcomes.Furthermore, many studies has suggested that artificial light should mimic natural sunlight to reach optimal effect. The benefit of sunlight in human wellbeing has been well documented, therefore we intend to utilize sunlight therapy for stroke patients in order to improve their physical and mental health.

Conditions

Stroke; Depression

Keywords

Sunlight; depression; daily active function; stroke

Outcome Measures

Primary Outcomes (2)

• depression status (Taiwanese depression scale, TDS)

  change depression status. Assess the feeling of body and mood within 7 days. Those who are above 19 will be considered as those with severe depression. 15-18 is divided into depression points to the critical point. 9-14 is divided into emotional ups and downs.

  8-12weeks

• physical activity function (Barthel Index)

  improved physical activity function. The total score of the scale is between 0 to 100 points. The higher the score, the better the activity Can be re-evaluated at different times, compare the difference in scores to determine whether daily life function is progressing or regressing

  8-12weeks

Secondary Outcomes (1)

• National Institute of Health Stroke Scale (NIHSS)

  8-12weeks

Other Outcomes (1)

• cognitive status (mini-mental state examination,MMSE).

  8-12weeks

Study Arms (2)

The experimental group

The first post-test measurements were taken right after the participants completed the sunlight therapy (two to four weeks after the start of the intervention), and the second post-test measurements were taken one month after the intervention was completed (six to eight weeks after the start of the intervention).

Behavioral: sunlight therapy

The control group

Standard care.The first and second post-test measurements were taken two and six weeks, respectively, after they started receiving standard care.

Interventions

sunlight therapy BEHAVIORAL

Exposed to sunlight for at least 30 minutes per day, at least 14 days of exposure duration of 4 weeks.

The experimental group

Eligibility Criteria

• Age: 24 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants had to be verified one-month post-stroke patients in stable condition, with an NIHSS score of not more than 15 (minor or moderate stroke).

You may qualify if:

• Participants also had to meet at least two of the Diagnostic and Statistical Manual(DSM)-IV diagnosis criteria for minor depression, dejection, or dysthymia, and had to be conscious and capable of expressing themselves. Participants had to be aged 20 or above, able to converse in or be literate in Mandarin or Taiwanese, and agree, after being asked to provide consent, to participate in this study.

You may not qualify if:

• Patients with a NIHSS score higher than 16 (severe stroke); patients with stroke caused by cancer metastasis; stroke patients with cancer comorbidity; and patients who were on dialysis, pregnant, mentally-challenged, or suffering from severe cognitive disabilities.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Su-Jen Wang

Taipei, 11217, Taiwan

Location

Related Publications (1)

• West A, Jennum P, Simonsen SA, Sander B, Pavlova M, Iversen HK. Impact of naturalistic lighting on hospitalized stroke patients in a rehabilitation unit: Design and measurement. Chronobiol Int. 2017;34(6):687-697. doi: 10.1080/07420528.2017.1314300. Epub 2017 Apr 21.

  PMID: 28430522 RESULT

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Miao-Yen Chen

  School of Nursing, National Taipei University of Nursing and Health Sciences.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 29, 2019
• Study Start: October 9, 2017
• Primary Completion: April 23, 2018
• Study Completion: April 23, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

TW (1)