Comparison of the effect of Chamomile, Rosa damascena and Alperazolam on the quality of sleep in patients with hemodialysis
Design
The clinical trial has 3 intervention groups, with parallel groups, randomized.
Settings and conduct
The study is a clinical trial study of 3 groups of 90 patients undergoing hemodialysis.
Participants/Inclusion and exclusion criteria
Entry Criterion: 1- Having at least 30 years and maximum 70 years of age 2- Awarded for participation in the study 3- A record of at least 6 months of hemodialysis 4. Performing hemodialysis at least twice a week and at least 3 hours 5- Awareness , Not having noticeable speech and speech disorder 6-No history of allergic rhinitis, eczema or known respiratory problems, such as asthma and lack of olfactory disorder 7-No known psychological illness and no drug addiction as 8-Not susceptible to Chamomile essential oil and flowers of Mohammadi9- Absence of acute illness 10- No admission to hospital and surgery
Exit criteria: 1. Non-collaboration during study 2. patient death 4. Renal transplantation
Intervention groups
Participants in two groups of Chamomile and Rose damascns each night and for seven nights, before going to bed, three drops of essential oil were poured on a cotton ball and put in a pre-prepared patch and put on the patient's clothes Snuggles, sniffs.In the third group, for seven nights, the alprazolam tablet is 0.5 before bedtime.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190521043663N1
Registration date:2019-06-20, 1398/03/30
Registration timing:prospective
Last update:2019-06-20, 1398/03/30
Update count:0
Registration date
2019-06-20, 1398/03/30
Registrant information
Name
Fatemeh Samiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3266 2676
Email address
f.samiei61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect aromatherapy Chamomile and Damask rose essential oil with Alprazolam on sleep quality of hemodialysis patient
Public title
The effect of aromatherapy on sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient be Agree to participate in the study
Patient have at least 6 months of hemodialysis
Patient have a hemodialysis at least twice a week, and minimum 3 hours each time
Patient have complete consciousness
Patient do not have well known auditory and speech disorder
Patient have no history of allergic rhinitis, eczema or known respiratory problems such as asthma and the absence of olfactory disorder
Patient do not have known mental disease
Patient not be addicted to drug
Exclusion criteria:
The test of the quality of sleep score base on using the Modified Pittsburgh Sleep Quality Index (PSQI) should be <5
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
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 Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, Southern Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸-۵۳۵۷۷
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR. BUMS.REC.1398.027
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis
Primary outcomes
1
Description
sleep quality
Timepoint
1-Before the intervention ,2- The seventh night after the intervention
Method of measurement
Pittsburg Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In this group, each night from 10 pm to 6 am for seven nights, before the patient goes to bed, three drops of essential oil rose damascene flower with a droplet on a cotton ball inside a patch already made Prepare it and put it on its clothes and smell it at bedtime. Group 2: This group every night from 10 pm to 6 am for seven nights before the patient goes to bed, three drops of essential oil Put Mohammad a dropper on a cotton ball in a pre-prepared patch and attach it to his clothes and at bedtime. Group 3: For seven nights, Alperazol tablets M 0.5 is consumed as directed by the physician.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
A comprehensive treatment center for specific patients