Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT05009693
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer
Sponsor:
Eskisehir Osmangazi University
Organization:
Study Overview
Official Title:
The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity.
It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows:
H0: White light has no effect on fatigue levels in patients with gynecological cancer.
H1: White light reduces fatigue levels in patients with gynecological cancer.
It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows:
H0: White light has no effect on fatigue levels in patients with gynecological cancer.
H1: White light reduces fatigue levels in patients with gynecological cancer.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: