Newborn, Infant, DiseaseNCT05770999
The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn
A study testing Lavender application in people with Newborn, Infant, Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Newborn, Infant, Disease
- What is being tested?
- Lavender application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2022to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Findings such as tachypnea, fever
- Newborns with Rh and AB0 incompatibility
- Newborns undergoing surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Newborns have to receive treatment and care for a long time in the neonatal unit. Newborns admitted to neonatal intensive care units (NICUs) have to cope with stressors such as numerous environmental stimuli (bright light, loud noise, frequent touch, etc.) and repetitive painful interventions when they are not developmentally ready. A care environment devoid of parental contact and stimuli, disturbing the newborn, and encountering stress and excessive stimuli negatively affects the delicate physical condition and immature organ systems of the newborn, and physiological and behavioral stress symptoms can be observed. However, in neonatal units; It is known that there may be many undesirable stimuli such as excessive noise, light, and intense activity in the unit, as well as situations where sensory stimuli such as monotonous sounds, inactivity, and silence from some medical equipment are rare. In these cases, sensory deprivation or sensory overload problems may develop as a result of the decrease or increase in the quality and quantity of sensory stimuli . Precautions should be taken to prevent these problems from occurring. Complementary care practices such as aromatherapy can be used to reduce sensory stimulus problems and stress.
Aromatherapy, which is the most widely used in complementary care applications; It is defined as the use of essential oils obtained from flowers, plants and trees to increase health and well-being. Essential oils can be administered orally, by touch, and by inhalation. The aim of aromatherapy by touch (massage, bath, compress) is to benefit from the anti-inflammatory, antispasmadic, antiviral, antifungal and antibacterial effects of essential oils and to allow the muscles to return to a resting tone. Since the sense of touch is developed in newborn babies at birth, the application of aromatic oils with the sense of touch is important in reducing the stress of the baby in the first days of his life.
Among the essential oils used in aromatherapy, the most studied fragrance is lavender. Lavender generally has antiseptic, anti-inflammatory, pain-relieving, relaxing and sleep-inhibiting effects. In line with this information, it is aimed to examine the effect of aromatherapy on the pain, stress and behavior of newborns.
- Conditions
- Newborn, Infant, Disease
- Being tested
- Lavender application
- Keywords
- Newborn, Aromatherapy, Pain, Stress, Newborn Behaviors
- Medical subject headings
- Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender applicationOther
Lavender application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change in behaviors over the 10 minute session (In all three groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start21 May 2022
- Primary completion20 Sep 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn, Infant, DiseaseStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Özbey, TC Erciyes University
- Investigators
- Öznur BAŞDAŞ, PhD, Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770999
- Sponsor's protocol ID
- 2021/04-02
- Status last verified
- Dec 2024
- First submitted
- 27 Oct 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn
- ClinicalTrials.gov ID
- NCT05770999
- Acronym / sponsor ID
- 2021/04-02
- Conditions
- Newborn, Infant, Disease
- Keywords
- Newborn, Aromatherapy, Pain, Stress, Newborn Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 21 May 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Newborns have to receive treatment and care for a long time in the neonatal unit. Newborns admitted to neonatal intensive care units (NICUs) have to cope with stressors such as numerous environmental stimuli (bright light, loud noise, frequent touch, etc.) and repetitive painful interventions when they are not developmentally ready. A care environment devoid of parental contact and stimuli, disturbing the newborn, and encountering stress and excessive stimuli negatively affects the delicate physical condition and immature organ systems of the newborn, and physiological and behavioral stress symptoms can be observed. However, in neonatal units; It is known that there may be many undesirable stimuli such as excessive noise, light, and intense activity in the unit, as well as situations where sensory stimuli such as monotonous sounds, inactivity, and silence from some medical equipment are rare. In these cases, sensory deprivation or sensory overload problems may develop as a result of the decrease or increase in the quality and quantity of sensory stimuli . Precautions should be taken to prevent these problems from occurring. Complementary care practices such as aromatherapy can be used to reduce sensory stimulus problems and stress.
Aromatherapy, which is the most widely used in complementary care applications; It is defined as the use of essential oils obtained from flowers, plants and trees to increase health and well-being. Essential oils can be administered orally, by touch, and by inhalation. The aim of aromatherapy by touch (massage, bath, compress) is to benefit from the anti-inflammatory, antispasmadic, antiviral, antifungal and antibacterial effects of essential oils and to allow the muscles to return to a resting tone. Since the sense of touch is developed in newborn babies at birth, the application of aromatic oils with the sense of touch is important in reducing the stress of the baby in the first days of his life.
Among the essential oils used in aromatherapy, the most studied fragrance is lavender. Lavender generally has antiseptic, anti-inflammatory, pain-relieving, relaxing and sleep-inhibiting effects. In line with this information, it is aimed to examine the effect of aromatherapy on the pain, stress and behavior of newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavender massage | Experimental | Other: Lavender applicationA 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. |
| Lavender bath | Experimental | Other: Lavender applicationA mixture of 20 cc bath water and 1 cc lavender oil will be used. lavender bath lasted about 10 minutes. |
| 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). |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- Findings such as tachypnea, fever
- Newborns with Rh and AB0 incompatibility
- Newborns undergoing surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender applicationLavender application | Other | Lavender bath, Lavender massage |
Primary outcome
Change in pain.
Time frame: Change in pain levels over the 10 minute session (In all three groups)
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.
Time frame: Change in stress levels over the 10 minute session (In all three groups)
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 behavior.
Time frame: Change in behaviors over the 10 minute session (In all three groups)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Öznur BAŞDAŞ, PhD study chair
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender application in people with Newborn, Infant, Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain. (time frame: Change in pain levels over the 10 minute session (In all three groups)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.