The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn

NCT05770999 | Completed

• 1 other identifier: 2021/04-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a randomized controlled double-blind experimental study to examine the effect of aromatherapy on newborn pain, stress and behaviors. The main questions it aims to answer are:

• Lavender oil massage applied to newborns has an effect on pain, stress and behavior of newborns.
• Lavender oil bath applied to newborns has an effect on pain, stress and behavior of newborns.
• There is a difference between lavender oil massage and lavender oil bath applications applied to newborns in reducing the pain and stress level of the newborn and regulating their behavior. Randomization method will be used in the determination of the study groups (Lavender massage, lavender bath and control group), and the study group to which the newborns will be included will be determined in the computer environment. Gender, gestational age, postnatal age and body weight will be considered as matching criteria for newborns included in lavender massage, lavender bath and control groups. For ALPS-Neo and ABSS evaluations, 10 minutes (20 minutes in total) of newborns will be recorded with a video camera before and after the study.

Conditions

Newborn, Infant, Disease

Keywords

Newborn; Aromatherapy; Pain; Stress; Newborn Behaviors

Outcome Measures

Primary Outcomes (3)

• Change in pain.

  Neonatal Pain and Stress Rating Scale; It was developed by Lundqvist et al. in 2014 to assess pain and stress in premature and newborns. The scale was adapted into Turkish by Ceylan and Bolışık (2017). It is a 3-point Likert-type scale consisting of 5 items: newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. As the score obtained increases, stress and pain increase. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The Cronbach's alpha coefficient of the scale was reported as 0.95.

  Change in pain levels over the 10 minute session (In all three groups)

• Change in stress.

  Neonatal Pain and Stress Rating Scale; It was developed by Lundqvist et al. in 2014 to assess pain and stress in premature and newborns. The scale was adapted into Turkish by Ceylan and Bolışık (2017). It is a 3-point Likert-type scale consisting of 5 items: newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. As the score obtained increases, stress and pain increase. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The Cronbach's alpha coefficient of the scale was reported as 0.95.

  Change in stress levels over the 10 minute session (In all three groups)

• Change in behavior.

  Anderson Behavioral State Scoring System-ABSS; In ABSS, which is a behavior scoring system that evaluates newborn behavior in 4 categories (eyes closed, eyes half-opened, eyes open and eyes open or closed) and 12 sub-categories, infant behaviors are scored from 1 to 12. As the score increases, it is accepted that the baby's behavior deteriorates.

  Change in behaviors over the 10 minute session (In all three groups)

Study Arms (3)

Lavender massage

EXPERIMENTAL

A mixture of 20 cc of sweet almond oil and 1 cc of lavender oil will be used. Sweet almond oil has been used to dilute lavender oil. lavender massage lasted about 10 minutes.

Other: Lavender application

Lavender bath

EXPERIMENTAL

A mixture of 20 cc bath water and 1 cc lavender oil will be used. lavender bath lasted about 10 minutes.

Other: Lavender application

Control group

NO INTERVENTION

The newborns in the control group did not receive any treatment other than their clinical routines (vital signs monitoring, skin care with sunflower oil, eye and mouth care, changing diapers, changing bed linen, feeding and clinical treatments).

Interventions

Lavender application OTHER

Lavender application

Lavender bath; Lavender massage

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postnatal age of 1-5 days,
• Gestational age is 38-42 weeks,
• Tolerant of enterally given food (without NEC, digestive system and chromosomal abnormalities),
• Not connected to respiratory support device,
• No skin disease,
• No surgical intervention,
• Newborns with written consent from at least one of the parents will be included in the study.

You may not qualify if:

• Findings such as tachypnea, fever
• Newborns with Rh and AB0 incompatibility
• Newborns undergoing surgical intervention

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disease; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Öznur BAŞDAŞ, PhD

  TC Erciyes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: March 16, 2023
• Study Start: May 21, 2022
• Primary Completion: September 20, 2022
• Study Completion: October 20, 2022
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)