Clinical trial NCT05573256: Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life
Official title: Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, and Health-related Quality of Life in Adults With a Stoma: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ostomy
Keywords: Ostomy
Sleep Hygiene
Lavander oil
Sleep
Fatigue
Quality of Life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Every night before going to bed (21:00-24:00), the participants will drop two drops of 2% lavender essential oil on a 2x2 cm cotton gauze pad in a bowl, place it at a distance of 15-20 cm from their pillows, and breath normally for 20 minutes. The participants will be instructed to repeat this process by dripping lavender oil onto a new gauze pad every night for four weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: a month
measure: Chalder Fatigue Scale (CFS)
timeFrame: a month
measure: Stoma Quality of Life Scale (SQLS)
timeFrame: a month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Rabia Koca
state: Eyalet/Yerleşke
Study officials:
affiliation: Marmara University, Institute of Health Sciences
name: Rabia Koca
role: PRINCIPAL_INVESTIGATOR
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