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

• Sponsor: KTO Karatay University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06008964
• Collaborator: Şerife İrem DÖNER (Other), Merve YAZAR (Other), JULE ERİÇ HORASANLI (Other)
• Enrollment: 96
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 38.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 15, 2023
• Actual Primary Completion Date: Aug 17, 2023
• Anticipated Study Completion Date: Aug 30, 2023

Arms and Interventions

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

Primary Outcome Measures

1. pain related to cesarean section [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	KTO Karatay University	Konya		Turkey	42000

Sponsors and Collaborators

• KTO Karatay University
• Şerife İrem DÖNER
• Merve YAZAR
• JULE ERİÇ HORASANLI

Investigators

• Study Chair: şerife irem döner, [e-mail]
• Study Chair: Merve Yazar, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hafize Dağ Tüzmen, LECTURER, KTO Karatay University
• ClinicalTrials.gov Identifier: NCT06008964
• Other Study ID Numbers: Aromatherapy Group
• First Posted: Aug 24, 2023
• Last Update Posted: Aug 24, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hafize Dağ Tüzmen, LECTURER, KTO Karatay University: Aromatherapy; pain; ceserean

Study Results

No Results Posted as of Aug 24, 2023