The Effect of Aromatherapy with Lavender Oil on Behavioral and Physiological Indices

Not Applicable

Recruiting

Conditions: Pain relief methods.
XXI Factors influencing health status and contact with health services
Z40-Z54 Pe

Registration Number: IRCT20221119056541N1

Lead Sponsor: Rasht University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Age 2 to 7 months
Being in the normal percentile of weight and height growth when receiving the vaccine
Term (38 to 42 weeks of pregnancy)
to be calm and not crying the infant before receiving the vaccine
The temperature is between36 to 37.2 degrees Celsius

Exclusion Criteria

Taking acetaminophen or any other pain reliever 3 hours before vaccination
Having a history of hospitalization
Suffering from diseases such as thyroid disorders, epilepsy and cardiovascular disease and acute diseases
Having trouble sleeping or insomnia before the vaccine injection

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain level. Timepoint: The pain level will be evaluated 5 minutes before, during and 5 minutes after the injection of the vaccine. Method of measurement: Using the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) , Which is a suitable tool for evaluating pain-related behaviors in children aged 2 months to 7 years. This scale has 5 parts and examines the level of pain through facial reactions, the way the legs are placed, the amount of mobility, crying and relaxation. A score of 0 to 2 is assigned to each of these sections, and finally the scores are added together. Based on the overall score, a score of zero means no pain and 10 means the most severe level of pain. The overall score is divided into three levels: a score of 0 to 3 indicates reduced pain, 4 to 7 indicates moderate pain, and 7 to 10 means severe pain.

Secondary Outcome Measures

Name	Time	Method
Physiological indices. Timepoint: Physiological indices (respiration rate, heart rate and arterial oxygen saturation percentage) will be evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the vaccine injection. Method of measurement: In order to measure the physiological indicators (arterial blood oxygen saturation level, heart rate), a children's finger pulse oximeter device of Zylux Med brand with code CMS 50 QB made in China will be used. To measure the breathing rate, the researcher will help after vision The videos record the number of breaths.;Duration of crying. Timepoint: At the same time as the needle enters the skin, the sound of the infant's cry is recorded. The criterion for the beginning and end of crying is based on the definition of the first cry from the first audible sound to the first pause that lasts at least five seconds. Method of measurement: Galaxy J7 Pro model SM-J730F chronometer will be used to measure the duration of infant crying.