The Effect of Honey on Nocturnal Cough and Sleep Quality

Meir Medical Center300 enrolled

Overview

Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Cough is a common symptom in pediatric practice.As a result, children miss daycare or school and parents miss a day of work. In an attempt to threat cough, caregivers frequently administer OTC medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the AAP and the FDA. The WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has antioxidant properties and increases cytokine release. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

300

Conditions

Cough Sleep

Interventions

Eucalyptus honeyDIETARY_SUPPLEMENT

Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.

Labiatae honeyDIETARY_SUPPLEMENT

Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.

Citrus honeyDIETARY_SUPPLEMENT

Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1-5 years of age complying of nocturnal cough that was attributed to a URI. Exclusion Criteria: * asthma, * pneumonia, * laryngotracheobronchitis, * sinusitis, * allergic rhinitis, * use of cough or cold medication on the night before entering the study.

Locations (1)

6 General Pediatric Community Clinics

Petah Tikva, Israel

Outcomes

Primary Outcomes

The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).

Pre intervention study questionnaire: The parents were asked to complete a five item questionnaire regarding parental subjective assessments of the child's cough and sleep difficulty on the previous night.Survey responses were graded on a seven point scale ranging from extremely (6 points) to not at all (0 points). On the day following the treatment,the parent completed the same questionnaire that had been answered before the intervention, this time regarding the previous evening when the child had received the treatment.

Time frame: changes between two nights ( the night before treatment and the night with treatment)

Secondary Outcomes

changes in the cough severity, the bothersome nature of the cough, the effect of the cough on sleep for both the child and parents between the two nights

Assessment was been done by completing the pre and post intervention questionnaire as was described in the " primary outcome measurment".

Time frame: changes between two nights ( the night before treatment and the night with treatment)

Data from ClinicalTrials.gov

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