NCT06008964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

April 18, 2023

Last Update Submit

October 25, 2023

Conditions

Cesarean Section Complications

Keywords

Aromatherapypainceserean

Outcome Measures

Primary Outcomes (1)

  • pain related to cesarean section

    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 Outcomes (1)

  • comfort related to cesarean section

    post operative 4-8-12 hours

Study Arms (3)

Ylang Ylang oil Group

ACTIVE COMPARATOR

GROUP 1

Other: Ylang Ylang oil with inhalation

Control Group

NO INTERVENTION

No intervention

Lavender oil

ACTIVE COMPARATOR

GROUP 2

Other: Lavender oil with inhalation

Interventions

Ylang Ylang oil with inhalationOTHER

Ylang Ylang OIL WILL BE INHALED

Ylang Ylang oil Group
Lavender oil with inhalationOTHER

LAVENDER OIL WILL BE INHALED

Lavender oil

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 18-49 who have undergone cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old,
  • women who have had a cesarean section

You may not qualify if:

  • epilepsy,
  • migraine,
  • chronic headache,
  • asthma,
  • women who are allergic to fragrance sensitivities to aromatic oils

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Inhalationlavender oil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • şerife irem döner

    serifeiremdoner@gmail.com

    STUDY CHAIR

  • Merve Yazar

    merve.yazar@karatay.edu.tr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

April 18, 2023

First Posted

August 24, 2023

Study Start

June 15, 2023

Primary Completion

August 17, 2023

Study Completion

October 25, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)