Back to resultsEffects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life (MU-RKOCA-01)
Primary Purpose
Ostomy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender oil inhalation
Sleep hygiene education
Sponsored by
About this trial
This is an interventional supportive care trial for Ostomy focused on measuring Ostomy, Sleep Hygiene, Lavander oil, Sleep, Fatigue, Quality of Life
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.
Sites / Locations
- Rabia Koca
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group 1 (Sleep hygiene education together with lavender oil inhalation)
Group 2 (Sleep hygiene education)
Group 3 (Lavender oil inhalation)
Group 4 (Routine care)
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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'.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05573256
Brief Title
Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
July 14, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ostomy
Keywords
Ostomy, Sleep Hygiene, Lavander oil, Sleep, Fatigue, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Sleep hygiene education together with lavender oil inhalation)
Arm Type
Experimental
Arm 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.
Arm Title
Group 2 (Sleep hygiene education)
Arm Type
Experimental
Arm 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.
Arm Title
Group 3 (Lavender oil inhalation)
Arm Type
Experimental
Arm 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.
Arm Title
Group 4 (Routine care)
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Lavender oil inhalation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
. 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'.
Time Frame
a month
Title
Chalder Fatigue Scale (CFS)
Description
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.
Time Frame
a month
Title
Stoma Quality of Life Scale (SQLS)
Description
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.
Time Frame
a month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Koca
Organizational Affiliation
Marmara University, Institute of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabia Koca
City
Istanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life
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