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OpenTrials
Completed

NCT Number: NCT07195136

Orenage Blossom Oil Essential Application in Stoma

Because the stoma will become a part of the individual's body and directly impact their quality of life, careful attention should be paid to its location and surgical procedure. Stoma care nurses should provide effective training to patients and those responsible for their care. Patients and their families should be regularly monitored, followed up, and cared for at home after discharge. They should also be provided with information about appropriate units to consult if any problems arise. Stoma support groups should be established to foster social interaction. A well-planned surgical procedure protects individuals from the development of complications and problems that can be considered a "life sentence."

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, 01330, Turkey (Türkiye)

About this study

This prospective, randomized, controlled study aims to investigate the effects of orange blossom essential oil placed in the stoma bag on odor reduction, social isolation, and stoma compliance in individuals with permanent colostomies. Sample size calculations were performed using a priori power analysis (t-test) for the intervention and control groups. Accordingly, with an effect size of d=1.12, a 5% error rate (α=0.05), and 80% power (1-β=0.80), the minimum sample size for both groups was calculated as 54. Considering potential losses, the total sample size will be increased by 10%, with 30 patients in each group (Experimental Group: 30, Control Group: 30), for a total of 60 patients. Data will be collected using a patient personal information form, a patient information form, a compliance scale for individuals with stoma, and a social isolation scale, all prepared by the researchers based on literature.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer to participate in the study
  • Over 18 years of age
  • With a stoma
  • No stoma-related complications

Exclusion criteria

  • Leaving the study

Treatment and study plan

Essential Oil

Behavioral

essential oil

Primary outcomes

  1. Stoma Adaptation Scale

    Time frame: 30 day

    Scale items are scored between 0 and 4. The minimum score is 0 and the maximum is 92. A higher score indicates greater compliance with the stoma.

  2. Social Isolation Scale

    Time frame: 30 day

    Scale items are scored on a 1-3 scale. The minimum score is 14 and the maximum is 42. As the score increases, the level of social isolation increases.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Investigation of the Effect of Orange Blossom Essential Oil Placed in the Stoma Bag on Odor Removal, Social Isolation, and Stoma Adaptation in Individuals With Stoma

Acronym: Stoma Care

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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