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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231213060353N1
Enrollment
100
Registered
2024-02-27
Start date
2024-01-21
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep quality of pregnant women in the third trimester.

Interventions

Intervention 1: 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

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Rastegari

Shiraz University of Medical Sciences

rategariz@sums.ac0ir+98 71 3647 4254

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026