- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008964
The Effect of Aromatherapy Applied After Cesarean Section on Pain Intensity and Comfort Level
October 25, 2023 updated by: Hafize Dağ Tüzmen, KTO Karatay University
Determination of the Effect of Aromatherapy Using Lavender and Ylang Ylang Essential Oils on Pain Severity and Comfort Level After Cesarean Section: A Randomized Controlled Study
Today, many complementary therapies such as acupuncture, reflexology, homeopathy, hypnotherapy, music and aromatherapy are tried in addition to medical methods to reduce pain and anxiety.
Aromatherapy is a therapy method in which essential oils are used to protect and improve physical and psychological health.
Oils can be applied directly to a single person or indirectly to people in a room by inhalation .
In direct application without steam, essential oils can be applied by inhalation by dripping onto a cotton ball .
It is stated that lavender aromatherapy, one of the most commonly used aromatherapies, has analgesic, antiseptic, sedative, antispasmodic and healing properties Ylang Ylang aromatherapy is stated analgesic, anti-inflammatory, antimicrobial, antiemetic,anti-tarral, carminative, sedative, antiseptic, spasmolytic properties.
In the studies conducted, anxiety, labor pain, labor duration, and psychological effects of aromatherapy were examined, but no study was found in which lavender and chamomile essential oils were used and the effects of pain and comfort level were examined.
The aim of this study is to determine the effect of lavender and Ylang Ylang essential oils in relieving pain and increasing comfort after cesarean section.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Konya, Turkey, 42000
- KTO Karatay University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-49 years old,
- women who have had a cesarean section
Exclusion Criteria:
- epilepsy,
- migraine,
- chronic headache,
- asthma,
- women who are allergic to fragrance sensitivities to aromatic oils
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention
|
|
|
Active Comparator: Ylang Ylang oil Group
GROUP 1
|
Ylang Ylang OIL WILL BE INHALED
|
|
Active Comparator: Lavender oil
GROUP 2
|
LAVENDER OIL WILL BE INHALED
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain related to cesarean section
Time Frame: post operative 4-8-12 hours
|
It will be measured with Visual Analog Scale.
Visual Analog Scale has a rating between 0-10.
The higher the score, the greater the pain.
|
post operative 4-8-12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comfort related to cesarean section
Time Frame: post operative 4-8-12 hours
|
Comfort will be measured with the postpartum comfort scale.
The higher the score, the higher the comfort level.
|
post operative 4-8-12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: MERVE YAZAR, merve.yazar@karatay.edu.tr
- Study Chair: şerife irem döner, serifeiremdoner@gmail.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Actual)
August 17, 2023
Study Completion (Actual)
October 25, 2023
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Aromatherapy Group
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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