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The Effect of Aromatherapy Applied After Cesarean Section on Pain Intensity and Comfort Level

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06008964
Recruitment Status : Completed
First Posted : August 24, 2023
Last Update Posted : October 26, 2023
Sponsor:
Collaborators:
Şerife İrem DÖNER
Merve YAZAR
JULE ERİÇ HORASANLI
Information provided by (Responsible Party):
Hafize Dağ Tüzmen, KTO Karatay University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Other: Ylang Ylang oil with inhalation Other: Lavender oil with inhalation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : June 15, 2023
Actual Primary Completion Date : August 17, 2023
Actual Study Completion Date : October 25, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ylang Ylang oil Group
GROUP 1
 Other: Ylang Ylang oil with inhalation
Ylang Ylang OIL WILL BE INHALED
No Intervention: Control Group
No intervention
Active Comparator: Lavender oil
GROUP 2
 Other: Lavender oil with inhalation
LAVENDER OIL WILL BE INHALED


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women aged 18-49 who have undergone cesarean section
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008964


Locations
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Turkey
KTO Karatay University
Konya, Turkey, 42000
Sponsors and Collaborators
KTO Karatay University
Şerife İrem DÖNER
Merve YAZAR
JULE ERİÇ HORASANLI
Investigators
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Study Chair: şerife irem döner serifeiremdoner@gmail.com
Study Chair: Merve Yazar merve.yazar@karatay.edu.tr
More Information
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Responsible Party: Hafize Dağ Tüzmen, LECTURER, KTO Karatay University
ClinicalTrials.gov Identifier: NCT06008964    
Other Study ID Numbers: Aromatherapy Group
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: October 26, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hafize Dağ Tüzmen, KTO Karatay University:
Aromatherapy
pain
ceserean