NCT05716711

Brief Summary

This study was planned to examine the effects of using the lavender essential oil and peppermint essential oil in stoma bags on odor removal, life satisfaction, and stoma compliance in patients with a stoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration 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

Study Start

First participant enrolled

April 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

July 19, 2022

Last Update Submit

January 27, 2023

Conditions

Keywords

COLOSTOMY, ODOR, LIFE SATISFACTION, STOMA HARMONY,

Outcome Measures

Primary Outcomes (1)

  • The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals with Colostomy

    İn patients with a permanent stoma; The level of discomfort from odor was measured by a questionnaire study using a numerical rating scale.

    1 month

Study Arms (3)

GROUP 1

EXPERIMENTAL

GROUP 1 1st GROUP LAVENDER OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY FOR 1 MONTH WITH 20 DROPS A DAY INTO THE STOMA BAG

Other: LAVENDER OIL

GROUP 2

EXPERIMENTAL

2nd GROUP MINT OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY DURING 1 MONTH.

Other: LAVENDER OIL

CONTROL GROUP

NO INTERVENTION

20 PATIENTS WITH COLOSTOMY WITH NO INTERVENTION

Interventions

IT WILL BE APPLIED TO 60 PATIENTS, 20 IN EACH GROUP, WITH A COLOSTOMY

Also known as: MINT OIL, NON-INTERVENTION
GROUP 1GROUP 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a stoma
  • To be compatible with essential oils

You may not qualify if:

  • Patients with allergic reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova Üniversitesi

Sarıçam, Adana, 01130, Turkey (Türkiye)

Location

Related Publications (1)

  • Alptekin D, Arslan S. The effect of different essential oils used in stoma bags of individuals with colostomy remooval of odor, life satisfaction and effect on stoma fit: Randomized controlled study. Explore (NY). 2024 Nov-Dec;20(6):103065. doi: 10.1016/j.explore.2024.103065. Epub 2024 Oct 9.

MeSH Terms

Conditions

Personal Satisfaction

Interventions

lavender oilSPEN protein, human

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • dudu alptekin

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: GROUP 1 GROUP2 CONTROL GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD STUDENT

Study Record Dates

First Submitted

July 19, 2022

First Posted

February 8, 2023

Study Start

April 22, 2020

Primary Completion

June 25, 2022

Study Completion

June 25, 2022

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

BETWEEN 2020 - 2022

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2020-2022
Access Criteria
FROM THE PATIENTS APPLYING TO THE STOMATHERAPY UNIT PATIENTS MEETING THE WORKING CRITERIA

Locations