Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life (MU-RKOCA-01)

Marmara University

Status: Completed

Conditions: Ostomy

Treatments: Behavioral: Lavender oil inhalation; Behavioral: Sleep hygiene education

Study type: Interventional

Funder types: Other

Identifiers

NCT05573256

MU-RKOCA-01

Details and patient eligibility

About

Self-care non-pharmacological methods can help reduce the negative health effects of sleep problems or insomnia. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with a stoma.

Full description

This study has been planned as a randomized controlled clinical trial and will use a 2x2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study population will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh Sleep Quality Index, their fatigue levels with the Chalder Fatigue Scale, and their quality of life with the Stoma Quality of Life Scale.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older,
• At least three months having passed after ostomy,
• Having a clear level of consciousness and no disease or medication use that can negatively affect the level of consciousness,
• Being able to communicate in Turkish,
• Providing informed written consent to participate in the study.

Exclusion criteria

• Lavender allergy,
• Respiratory tract infections such as sinusitis and pneumonia,
• Body mass index (BMI) of >40,
• A diagnosis of sleep disorder and/or medication use for sleep problems.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Group 1 (Sleep hygiene education together with lavender oil inhalation)

Experimental group

Description:

the participants assigned to Group 1 will be given sleep hygiene education and instructed how to apply lavender oil inhalation. The participants will be provided with charts on sleep hygiene education and lavender oil inhalation and shown how to regularly keep daily records using their charts. The participants in this group will be given a copy of the sleep hygiene education brochure and lavender oil in a 10 ml bottle.

Treatment:

Behavioral: Lavender oil inhalation

Behavioral: Sleep hygiene education

Group 2 (Sleep hygiene education)

Experimental group

Description:

The participants assigned to Group 2 will only be given sleep hygiene education. They will be provided with a copy of the sleep hygiene education brochure and a chart on which to record their sleep hygiene practices.

Treatment:

Behavioral: Sleep hygiene education

Group 3 (Lavender oil inhalation)

Experimental group

Description:

The participants assigned to Group 3 will only be instructed on how to apply lavender oil inhalation and keep regular daily records on the chart given. The participants in this group will be given lavender oil in a 10 ml bottle.

Treatment:

Behavioral: Lavender oil inhalation

Group 4 (Routine care)

No Intervention group

Description:

Participants assigned to Group 4 will be given routine care and no application will be made. Patient care and follow-up are routinely performed as follows: Following the patient's admission to the clinic, the first evaluation of the patient is made by the ostomy and wound care nurses within 24 hours, and patient education is initiated accompanied by the primary caregiver from the family. Throughout the period from admission to clinic to discharge, the ostomy care and education of the patient is repeated by the ostomy and wound care nurses every 72 hours. In addition, the patient and caregiver are given the contact information of the ostomy and wound care nurses and informed that they can call them at any time when they need it after discharge from the hospital.