MedPath

Evaluation of the effectiveness of Melissa Officinalis L. nasal drop on the quality of sleep in pregnant wome

Phase 3
Conditions
Sleep quality of pregnant women in the third trimester.
Registration Number
IRCT20231213060353N1
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
© Copyright 2025. All Rights Reserved by MedPath