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The Effect of Lavender Aromatherapy on the Behavioral Reactions of Preterm neonate in the neonatal intensive care unit.

Protocol summary

Study aim
effect of lavender aromatherapy on behavioral reactions of preterm neonates
Design
The clinical trial has a control group with single-blind, parallel groups, randomized, phase 3, on 86 infants. RANDOM ALLOCATION SOFTWARE will be used for the randomization sequence.
Settings and conduct
This study will be conducted in the neonatal intensive care unit of Ghaem Hospital in Mashhad. In the intervention group, behavioral reactions will be recorded before the intervention begins. The newborn will be subjected to lavender aromatherapy for one hour. Immediately after the aromatherapy is completed and half an hour later, behavioral reactions will be scored according to the ABSS scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonatal age 28-34 weeks gestation Under non-invasive ventilation Having stable vital signs Apgar score at birth at 5 minutes above 6 No invasive procedure performed on the newborn 2 hours ago Absence of all types of neonatal anomalies Informed parental consent. Exclusion criteria: Gestational age greater than 34 weeks Addicted mother,intubated neonate,neonate has nasal cannula, Using narcotics and sedatives
Intervention groups
In the intervention group, infants will be exposed to lavender aromatherapy for one hour. Infants will be observed for 30 seconds over two consecutive days, once before the aromatherapy is applied, twice after the aromatherapy begins, once immediately after the aromatherapy ends, and a second time half an hour after the aromatherapy ends, and their behaviors will be recorded using the Anderson behavioral scale.The study will be conducted over two consecutive days from 3:00 PM to 5:00 PM, .In the control group, No scent will be used for this group, and the behavioral response will be examined.
Main outcome variables
Behavior.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250712066456N1
Registration date: 2025-09-04, 1404/06/13
Registration timing: prospective

Last update: 2025-09-04, 1404/06/13
Update count: 0
Registration date
2025-09-04, 1404/06/13
Registrant information
Name
maedeh robabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 4906
Email address
robabim4022@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lavender Aromatherapy on the Behavioral Reactions of Preterm neonate in the neonatal intensive care unit.
Public title
The Effect of Lavender Aromatherapy on the Behavioral Reactions of Preterm neonate in the neonatal intensive care unit.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of newborns 28-34 weeks of pregnancy Apgar score at birth at 5 minutes above 6 Lack of various neonatal anomalies The baby has not had an invasive procedure performed on him/her within the last 2 hours. Having stable vital signs
Exclusion criteria:
Edict's mother Gestational age greater than 34 weeks Using narcotics and sedatives for the baby Intubate neonate Nasal cannula neonate.
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the sequence of random allocation of individuals to the studied groups uses the method of replaced blocks and software Random Allocation Software. Due to the sample size of 43 cases per group, the first of the six possible blocks of four blocks of four "AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6)" was selected by accident and then the individuals were assigned to Group B and A. For example, if the first block, ABBA, is selected, the first and fourth person will be assigned to Group A and the second and third to Group B. This will continue until the sample size is completed. The characteristic of this method is that the two study groups will have equal number.
Blinding (investigator's opinion)
Single blinded
Blinding description
It is inserted into the incubator to blind the aroma by a person. Group A is the intervention group and group B control. Due to the random sequence selected, the fragrance is inserted for one hour. Babies are kept in the incubator, which is a completely closed environment and there is no fragrance release. After an hour of evaluation, the evaluation of the neonates under study and scores the behavioral reaction of infants. The statistical analyst will also perform the analysis and interference without knowing the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mashhad University Medical science
Street address
Ferdowsi University kharazmi complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2025-07-15, 1404/04/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1404.050

Health conditions studied

1

Description of health condition studied
Behavioral reaction of premature neonate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Behavioral Reactions of Preterm neonate
Timepoint
Before the intervention, immediately after the intervention, half an hour after the intervention
Method of measurement
Anderson Behavioral Scale system.(ABSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: : The scent of lavender is placed ten centimeters away from the baby's head for one hour. The behavioral response of the infants will be observed for 30 seconds once before placing the lavender scent in the incubator, and twice after the aromatherapy is completed, once immediately after the aromatherapy is completed, and the second time half an hour after the aromatherapy is completed, and will be determined using the Anderson tool and recorded in a table. The study will be conducted from 3:00 PM to 5:00 PM, after feeding and routine nursing care, to minimize confounding factors. During the study, the infants' breathing rate and heart rate will be monitored to maintain patient safety.We dissolve one drop of 100% water-soluble lavender essential oil from the company Gaya Kala with 4 cc of warm distilled water and use it. The concentration of the solution obtained will be one percent.Linalool and linalyl acetate are the two main ingredients effective in calming.Dilution will be performed using standard droppers in the laboratory.
Category
Behavior

2

Description
Control group: In routine conditions and according to the intervention group's schedule, the behavioral response of premature infants will be recorded according to the Anderson instrument. This study will be conducted after feeding and routine nursing care, from 3:00 PM to 5:00 PM in order to reduce confounding factors. During the study, the respiratory rate and heart rate of the infants will be monitored to maintain patient safety. .
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
ghaem hospital
Full name of responsible person
maedeh robabi
Street address
Mashhad, Ahmadabad Street, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۶۶
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Mashhad, University Street, Central Building, Mashhad University of Medical Sciences, Vice Chancellor for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۸۸۱۳۹۴۴
Phone
+98 51 3841 1538
Email
Tagsghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MAEDEH ROBABI
Position
MASTER STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
delavaran 21
City
Mashhad
Province
Razavi Khorasan
Postal code
9177138738
Phone
+98 51 3822 4906
Email
robabim4022@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
naghme razaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ferdowsi University, Shahid Kharazmi Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3859 1511
Fax
Email
Razaghin@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
maede robabi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
delavaran 21
City
Mashhsd
Province
Razavi Khorasan
Postal code
9177138738
Phone
+98 51 3822 4906
Email
robabim4022@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The behavioral response of premature infants, which is the main outcome of this study, will be presented.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Academic and industrial researchers
Under which criteria data/document could be used
Academic and industrial researchers
From where data/document is obtainable
Maedeh Rababi, Master's student, Mashhad School of Nursing, Pediatric and Neonatal Department
What processes are involved for a request to access data/document
Send your request via email, it will be responded to as soon as possible.
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