The effect of rose flower aroma on sleep quality of women during the postpartum
Design
A randomized controlled clinical trial with parallel groups, randomized, without blinding
Settings and conduct
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Lack of severe pain disruptive sleep
2) Lack of aromatherapy experience until now
3) Not using complementary medicine in recent weeks
4) Being alert (knowing time, place and person)
5) Lack of sleeping conditions (such as rheumatoid arthritis and migraine)
6) No known sleep disorder according to the patient
7) No history of asthma and allergies
8) Not having a history of allergy and eczema to flowers and plants and the smell of sweat and their essential oils
9) Not taking drugs 6 hours before bedtime
10) Not being addicted
11) No use of psychotropic drugs
12) Lack of care or treatment during bedtime
13) Lack of orthopnea and respiratory problems
14) Baby age 20 -25 days
Exclusion criteria
15) Exclusive Breastfeeding
1) Severe sensitivity to the scent of rose flowers during the study
2) The patient's unwillingness to continue participating in the study
3) Arbitrary use of sedatives
4) Orthopedics and respiratory problems during the study
5) Getting sick
Intervention groups
For 3 nights - the napkin is dipped in rose essential and pinned to the pillow. The control group will receive no intervention
Main outcome variables
women's sleep quality during the postpartum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045079N1
Registration date:2019-11-05, 1398/08/14
Registration timing:prospective
Last update:2019-11-05, 1398/08/14
Update count:2
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
hadis fattah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 6516
Email address
hadisfth@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-03, 1398/09/12
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose water aromatherapy on womenꞌs sleep quality in postpartum period
Public title
The effect of rose aroma on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster sampling:
By cluster sampling, health centers are selected from 5 districts of Arak city and then sampled from each of the selected clinics in proportion to the population covered.
Random Number Table: Randomly divided into two groups of 42 intervention and control groups
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 Arak University of Medical Sciences
Street address
Aram - Shahid Shiroudi Street - Alam Hadi Street
City
arak
Province
Markazi
Postal code
۶۸۱۹۷۶۳۳۸۳
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.ARAKMU.REC.1398.176
Health conditions studied
1
Description of health condition studied
Poor sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sleep quality
Timepoint
Baseline - After 3 nights inhalation of rose scent
Method of measurement
Petersburg questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inhale the Mohammadi scent for three consecutive nights.
Category
Rehabilitation
2
Description
Control group: they will not receive any intervention