Protocol summary
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Study aim
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The effect of rose flower aroma on sleep quality of women during the postpartum
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Design
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A clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 84 people, a random number table was used for randomization.
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Settings and conduct
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Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow. The project was carried out in Arak city and between clients of health clinics.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Lack of severe pain disruptive sleep
; Lack of experience in aromatherapy
; Do not use complementary medicine in the last week
; Awareness (awareness of time, place and person)
; Lack of underlying disease affecting sleep (such as rheumatoid arthritis and migraine)
; No known sleep disorder according to the patient
; No history of asthma and allergies
No history of allergies and eczema to flowers and plants and the smell of sweat and their essential oils
; Do not take drugs 6 hours before bedtime
; Not addicted
; Do not take psychiatric drugs
; Lack of care or treatment plan during bedtime
; Lack of orthopnea and respiratory problems
; Baby age 20 to 25 days
; Exclusive breastfeeding
; Criteria for not entering:
; Severe sensitivity to the scent of rosemary during the study.
; The patient's unwillingness to continue participating in the study
; Arbitrary use of sedatives
; Orthopedics and respiratory problems during the study
; The patient becomes ill
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Intervention groups
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For 3 nights - the napkin is dipped in rose essential and pinned to the pillow. The control group will receive no intervention
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Main outcome variables
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women's sleep quality during the postpartum
General information
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Reason for update
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Record sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191013045079N1
Registration date:
2019-11-05, 1398/08/14
Registration timing:
prospective
Last update:
2020-11-26, 1399/09/06
Update count:
2
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Registration date
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2019-11-05, 1398/08/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-03, 1398/09/12
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Expected recruitment end date
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2020-01-20, 1398/10/30
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Actual recruitment start date
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2019-12-03, 1398/09/12
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Actual recruitment end date
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2020-03-18, 1398/12/28
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Trial completion date
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2020-05-19, 1399/02/30
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Scientific title
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The effect of rose water aromatherapy on womenꞌs sleep quality in postpartum period
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Public title
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The effect of rose aroma on sleep quality
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Lack of severe pain disruptive sleep
No experience of aromatherapy until now
No use of complementary medicine in recent weeks
Being alert (knowing time, place and person)
Lack of sleeping conditions (such as rheumatoid arthritis and migraine)
No known sleep disorder according to the patient
No history of asthma and allergies
Not having a history of allergy and eczema to flowers and plants and the smell of sweat and essential oils
Do not take drugs 6 hours before bedtime
Not being addicted
No psychotropic drugs
Lack of care or treatment during bedtime
Lack of orthopnea and respiratory problems
Baby age 20 to 25 days
Exclusive Breastfeeding
Exclusion criteria:
Severe sensitivity to the scent of Mohammadi flowers during the study.
Patient's unwillingness to continue participating in the study
Arbitrary use of sedatives
Orthopnea and Respiratory Difficulty During Study
Getting sick
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
84
Actual sample size reached:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Cluster sampling:
According to cluster sampling, health centers will be selected by lot from 5 districts of Arak city and then sampling will be done from each of the selected clinics in proportion to the population covered.
Random number table: Randomly divide people into two groups of 42 people intervention and control, assign a three-digit code to each person and then create a number table, randomly select three consecutive numbers in a row or column.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-15, 1398/06/24
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Ethics committee reference number
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IR.ARAKMU.REC.1398.176
Health conditions studied
1
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Description of health condition studied
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Poor sleep quality
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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sleep quality
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Timepoint
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Baseline - After 3 nights inhalation of rose scent
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Method of measurement
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Petersburg questionnaire
Intervention groups
1
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Description
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Intervention group: Inhaling the scent of Mohammadi flower from 10% essential oil of Mohammadi flower made in by Barij company, Iran, for three consecutive nights and for at least 8 hours every night.
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Category
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Rehabilitation
2
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Description
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Control group: they will not receive any intervention
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Start accessing 6 months after printing results
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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No more conditions
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From where data/document is obtainable
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email
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What processes are involved for a request to access data/document
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Upon request by email
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Comments
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