This study will be done with aim to investigate the effectiveness of melatonin on sleep quality in patients with cancer. This study is a not blinded clinical trial. The study population included patients with cancer who referred to Imam Reza Hospital in Kermanshah city. 44 patients in available method will be selected and will be assigned in the intervention group. Before the intervention, the Pittsburgh Sleep quality questionnaire will be completed in all patients. Then the patients of the study will receive 3 mg of melatonin daily for 1 month. Patients will be visited every week. At the end of the study the Pittsburgh Sleep quality questionnaire will be completed and the complications and problems associated with sleep medications will be compared with the initial results. Inclusion criteria: age between 16 to 80; Cancer patients who have trouble sleeping and chemotherapy have done for them and ended Exclusion criteria: patients with underlying disorders and uncontrolled medical problems such as diabetes; hypertension; seizures; addiction
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051027840N1
Registration date:2016-06-30, 1395/04/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Sepideh Tanhaie
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3722 3365
Email address
s.tanhaie@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of effectiveness and non effectiveness of melatonin in sleep quality in patients with
Public title
investigation of melatonin in sleep quality in patients with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 16 to 80; Cancer patients who have trouble sleeping and chemotherapy have done for them and ended
Exclusion criteria: patients with underlying disorders and uncontrolled medical problems such as diabetes, hypertension, seizures; addiction and continuous use of sleep medications and anticoagulants and anticonvulsants; Individuals treated with anticoagulants and anticonvulsants and antidepressants and sleeping drugs
Age
From 16 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
KUMS.REC.1394.186
Health conditions studied
1
Description of health condition studied
sleep quality disorders
ICD-10 code
G47
ICD-10 code description
sleep disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Baseline,once a week for a amonth
Method of measurement
Based on pittsburgh sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive 3 mg of melatonin daily for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sepideh Tanhaie
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sepideh Tanhaie
Position
Student of Medical
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
s.tanhaie@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Negin Farshchian
Position
Oncologists
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
negin10860@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sepideh Tanhaie
Position
Student of Medical
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
s.tanhaie@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)