This study will be done with aim to investigate the effect of Rose esence on the sleep quality of hemodialysis patients in Imam Reza hospital of Kermanshah in 2015. This study is a nonblinded clinical trial. The study population includes undergoing hemodialysis patients that refer to Imam Reza hospital of Kermanshah city. Before starting the study, the patients will receive Pittsburgh Sleep Quality questionnaire and a total of 32(study will done in phase 2) will selected and randomly will be assigned in two exprimental and control groups (16 members).Experimental group will use 3 drops of Rose esence 10%, every night before bed for a month. Patients and attendants will trained, while using spills 3 drops of Rose esence on a cotton ball into a layer of fabric that had already been prepared and will put them, and by a small pin install on the collar and breathing during the night and the morning after awakening separate from collar. In the control group will used sesame oil as a placebo. After the last day of the intervention, when they referring to the ward for hemodialysis, both groups will receive the final questionnaire and sleep quality will compared in the two groups. Inclusion criteria: Patient informed consent; History of dialysis at least 6 months at a rate of 1 to 7 times a week. Exclusion criteria: A score less than 5 of Pittsburgh Sleep Quality scale; Failure to perform systematic interventions for one third of intended time
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110214333N45
Registration date:2016-02-15, 1394/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-15, 1394/11/26
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness and ineffectiveness of Rose esence on the sleep quality of hemodialysis patients
Public title
Investigate the effect of Rose esence on the sleep quality of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 15 to 70 years; Patient informed consent; Patients undergoing hemodialysis; At least 6 months history of dialysis at a rate of 1 to7 times a week; Lack of Allergic Diseases Exclusion criteria: A score less than 5 of Pittsburgh Sleep Quality scale; Failure to perform systematic interventions for one third of intended time.
Age
From 15 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
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
2015-10-20, 1394/07/28
Ethics committee reference number
kums.rec.1394.123
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Subjective sleep quality
Timepoint
Base line and end of the study (one month after the beginning of the study)
Method of measurement
By Pittsburgh Sleep Quality questionnaire
2
Description
Sleep latency
Timepoint
Base line and end of the study (one month after the beginning of the study)
Method of measurement
By Pittsburgh Sleep Quality questionnaire(PSQI)
3
Description
Duration of sleep
Timepoint
Base line and end of the study (one month after the beginning of the study)
Method of measurement
By Pittsburgh Sleep Quality questionnaire(PSQI)
4
Description
Sufficient sleep
Timepoint
Base line and end of the study (one month after the beginning of the study)
Method of measurement
By Pittsburgh Sleep Quality questionnaire(PSQI)
5
Description
Sleep disturbances
Timepoint
Base line and end of the study (one month after the beginning of the study)
Method of measurement
By Pittsburgh Sleep Quality questionnaire(PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group will use 3 drops of Rose esence 10%, every night before bed for a month. Patients and attendants will trained, while using spills 3 drops of Rose esence on a cotton ball into a layer of fabric that had already been prepared and will put them, and by a small pin install on the collar and breathing during the night and the morning after awakening separate from collar.
Category
Treatment - Drugs
2
Description
In the control group will used sesame oil as a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Touraj Mohamadyari
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Hadadian
Position
Master of Science in Medical Surgical Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
- daneshjoo.610@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)