Determination and comparison between and within groups of the average sleep duration, sleep adequacy index, time to fall asleep, and quality of sleep in the intervention and control groups before and after the intervention
Design
The study's method will be a double-blind, randomized controlled clinical trial, with a simple random sampling method. The total sample size, will be 100 persons. Permutation blocks method will be used for random assignment of treatment type.
Settings and conduct
At first, relevant permits and an informed consent form will be obtained. In order to collect data, the demographic profile questionnaire and Pittsburgh sleep quality questionnaire will be used. Mothers with mild to moderate sleep disorders will be included in the study. The method of blinding is double-blind, and the researcher is not aware of the contents of the drops, and only the person's name is entered in the randomization table based on the code that the person has, and the oils are provided to patients by one of the pharmacy colleagues. patients will be re-examined in the 4th and 8th weeks after starting to use the drug. The way to take the medicine is to use one drop of the drug in each nostril twice in the morning and at night. In case of complications or problems, they will be removed from the study. The information of the project will be kept completely confidential.
Participants/Inclusion and exclusion criteria
Pregnant women who suffer from sleep disorders and don't mention any past medical history. In case of any past medical history, they will not be included in the study
Intervention groups
Pregnant women who receive lemon balm drops and those who receive neutral drops
Main outcome variables
Improving daily performance; reducing mother's fatigue; increasing family well-being; reducing anxiety; improving immune system, Hypothalamus, Pituitary and Adrenal function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231213060353N1
Registration date:2024-02-27, 1402/12/08
Registration timing:retrospective
Last update:2024-02-27, 1402/12/08
Update count:0
Registration date
2024-02-27, 1402/12/08
Registrant information
Name
Negin Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5507 0589
Email address
rastegariz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-02-03, 1402/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Melissa Officinalis L. nasal drop on the quality of sleep in pregnant women
Public title
Evaluation of the effectiveness of Melissa Officinalis L. nasal drop on the quality of sleep in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Gestational age of 28-34 weeks after obtaining informed consent
Mother's first pregnancy (mother's nulligravidity)
Suffering from mild and moderate sleep disorder by self-report and according to the Pittsburgh Questionnaire
Ability to answer questionnaire questions
Not using complementary medicine during the previous three months
No dependence or addiction to alcohol, drugs, tobacco and medicines
Not having family problems
No history of any respiratory allergy
Not having a history of allergy to Lemon balm or cross-reaction with the mint family as self-reported
Exclusion criteria:
Taking drugs that affect the sleep-wake cycle
The presence of any problems in the pregnancy process
Suffering from depression or anxiety (self-reported and the need to take medication)
Suffering from any psychological factor interfering with sleep disorders
Suffering from kidney diseases, heart failure, respiratory disorders and sleep-wake cycle diseases such as espiratory apnea and restless leg syndrome.
Showing any allergic reaction to lemon balm oil
continuous consumption (twice or more per week) of Lemongrass tea or extract during the last month
having problems related to airway and nasal obstruction and Sinusitis
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all study groups will contain equal sample size, which can be used by limited randomization. The method that is used in this study, will be permuted block randomization . In this method, the size of all blocks will be equal and 10 blocks of 10 will be selected by the "Random software allocation" software, which is capable of generating a random sequence using the permutation block method. The randomization unit in this study will be an individual unit.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is double-blind, and the researcher is not aware of the contents of the drops, and only the person's name is entered in the randomization table based on the code that the person has. The oils whose content is unknown and only have A and B labels, are given to patients by one of the pharmacy colleagues.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No. 39, Joahari Naad Ave., Shir Mohamadi St. , Nazi Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1811619833
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.106
Health conditions studied
1
Description of health condition studied
Sleep quality of pregnant women in the third trimester
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of pregnant women who have sleep disorders
Timepoint
Registration of Pittsburgh sleep quality questionnaire at the beginning of the study (before the start of the intervention) and 4 and 8 weeks after starting the use of Lemon balm oil drops
Method of measurement
Pittsburgh sleep quality questionnaire
Secondary outcomes
1
Description
Sleep quality score
Timepoint
At the beginning of the study and 4 and 8 weeks after the beginning of Lemon balm oil drops
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group: pregnant women suffering from sleep disorders referring to the pregnancy clinic of Mahdiyeh Hospital: a prepared and approved sample of Melissa Officinalis will be poured into a standard amount of neutral oil and then a standard amount of sterile water will be added to it. then It will be expousered to indirect heat so the water will completely be evaporated, and finally, the remaining plant will be filtered from the oil so the final product of lemongrass plant oil will be derived from it. The method of using neutral oil (placebo) and lemon balm oil (intervention) is to drip one drop of the respective oil in each nostril twice a day . The medication will be consumed for 8 weeks. The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: pregnant women suffering from sleep disorders referring to pregnancy clinic of Mahdiyeh Hospital who receive neutral oil. neutral oil is an oil that has no effect in the treatment of sleep disorder and its preparation is industrial and contains liquid Paraffin.The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences.