Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life

Ostomy Clinical Trial

— MU-RKOCA-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573256
• Other study ID #: MU-RKOCA-01
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 15, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Ostomy

Intervention

Behavioral:
• Lavender oil inhalation
Lavender oil inhalation;During the trial, the participants will be asked to practice lavender oil inhalation as follows: 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.
• Sleep hygiene education
Sleep hygiene education;The participants assigned to Groups 1 and 2 will receive sleep hygiene education using the sleep hygiene education brochure, which has been prepared by the researchers based on the literature concerning the improvement of general sleep quality in individuals with a stoma.

Locations

Country	Name	City	State
Turkey	Rabia Koca	Istanbul	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI)	. It consists of seven subscales with a total of 19 items, of which 18 are included in scoring. Each item is evaluated over 0-3 points, and the sum of the seven subscale scores constitutes the total PSQI score. The total score that can be obtained from the scale ranges from 0 to 21, and a high total score indicates poor sleep quality. A total PSQI score of =5 indicates 'good sleep', and a score of >5 indicates 'poor sleep'.	a month
Primary	Chalder Fatigue Scale (CFS)	The scale consists of 11 items, seven evaluating physical fatigue and four evaluating mental fatigue. There are four options for response to the items in the scale (less than usual, no more than usual, more than usual, and much more than usual). The overall fatigue score is obtained by summing the scores in the physical and mental fatigue subscales. The physical fatigue subscale score ranges from 0 to 21, the mental fatigue subscale score ranges from 0 to 12, and the total fatigue score ranges from 0 to 33. An increase in the scale score indicates an increase in the severity of fatigue.	a month
Primary	Stoma Quality of Life Scale (SQLS)	The remaining items are grouped into three subscales: work/social life (six items), sexuality/body image (five items), and stoma function (six items). In addition, there is one item related to the economic situation and one item related to skin irritation, which do not fall into any of the previously mentioned subscales. Minimum and maximum scores for each subscale are 0 and 100, respectively, with high scores indicating an increase in quality of life. If two items in any subscale are left unanswered in the scale, the relevant subscale is not taken into consideration during scoring, but if one item is left unanswered, it can be included in evaluation.	a month