Determining the effect of red light on the sleep quality of patients admitted to the intensive care unit of the heart
Design
A community based, pragmatic, control group clinical trial was randomized with parallel groups, on 80 patients.
Settings and conduct
Sleep disorders are a common problem in heart patients. One of the complementary medicine methods for treating sleep disorders is the use of red light. This clinical trial will be conducted in the cardiac intensive care units of Beheshti Hospital in Kashan without blinding. In the intervention group, patients will be exposed to red light for two vonsecutive nights from 22:00 to 06:00. In the control group, there will be no intervention. Patients will complete the standard sleep quality questionnaire of saint mary's hospital in the morning of the first day before the intervention and then in the morning of the first and second day after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: admission letter and cardiologist's consent, age 30 to 75 years, ability to speak and understand and alert, no Intubation, no severe heart failure; Exclusion criteria: unwillingness to continue the research, incomplete answers to the questionnaires, discharge earlier than the end of the intervention, transfer from the ward, cardiopulmonary resuscitation, non observance of light conditions
Intervention groups
Intervention group: the Light emitted from an infrared lamp with a red filter without visible light of 50 watts with a wavelength of more than 700 NM , while the curtains of the patient's room will be drawn and movement will be limited to the patient's room; It will take place for 2 consecutive nights from 22:00 to 6:00 in the morning. In the control group, there is no change in the room light.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N53
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of red light on the quality of sleep of patients hospitalized in the cardiac intensive care unit
Public title
Investigating the effect of red light on the sleep quality of cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Admission letter from the cardiologist and the consent of the attending physician to perform the lntervention
Age between 30 and 75 years
Written consent of the lndividual to enter the study
Patients who are able to speak and understand the language and are alert
At least 24 hours have passed since hospitalization
No intubation
Absence of severe heart failure
Minimum MMSE score equal to 22
Exclusion criteria:
Reluctance to continue participating in research
Incomplete answers to questionnaires
Discharge earlier than the end of the intervention
Moving from the department (such as performing a procedure in the operating room, etc.)
Performing cardiopulmonary resuscitation
Failure to comply with the conditions related to the change of light
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For the sampling method, first the elegible Ssmples will be selected as available and using computer software on the sealed envelope website by placing the number of groups and the total uumber of samples and the number of samples in each block (the total number of samples is 80 people and the number of samples in each block is 8 people) a list of 10 rapndom blocks will be prepared, in each block, 4 people from each group will be placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of nursing and midwifery school, Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2024-04-14, 1403/01/26
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1403.005
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I51
ICD-10 code description
Complications and ill-defined descriptions of heart disease
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, 1 and 2 days after the intervention
Method of measurement
Saint Mary's Hospital Sleep Quality Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for 2 consecutive nights, from 10:00 PM to 6:00 AM, the room lamps will be turned off and to prevent the white light from the corridors, the room curtains will be drawn and movement will be limited to the patient's room. So, with the reading light which has an infrared lamp with a red filter without visible light, 50 watts with a wavelength of more than 700 NM, Lucky herp brand, the light in the room will be changed to red light.
Category
Other
2
Description
Control group: There is no Change in the Light of the Room
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Seyed Mehdi Motahary Barzoki
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Fax
+98 31 5558 9200
Email
motaharysme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Fax
+98 31 5558 9338
Email
hamidi_gh@kaums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher Ajorpaz
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Fax
+98 31 5558 9392
Email
mirbagher_n@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher Ajorpaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Fax
+98 31 5558 9392
Email
mirbagher_n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Mehdi Motahary Barzoki
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Fax
+98 31 5558 9392
Email
motaharysme@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of Participants are Confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available