- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573256
Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life (MU-RKOCA-01)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Eyalet/Yerleşke
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Istanbul, Eyalet/Yerleşke, Turkey, 34000
- Rabia Koca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 (Sleep hygiene education together with lavender oil inhalation)
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.
|
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;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.
|
Experimental: Group 2 (Sleep hygiene education)
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.
|
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.
|
Experimental: Group 3 (Lavender oil inhalation)
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.
|
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.
|
No Intervention: Group 4 (Routine care)
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: a month
|
. 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
|
Chalder Fatigue Scale (CFS)
Time Frame: a month
|
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
|
Stoma Quality of Life Scale (SQLS)
Time Frame: a month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia Koca, Marmara University, Institute of Health Sciences
Publications and helpful links
General Publications
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Lim SH, Chan SW, He HG. Patients' Experiences of Performing Self-care of Stomas in the Initial Postoperative Period. Cancer Nurs. 2015 May-Jun;38(3):185-93. doi: 10.1097/NCC.0000000000000158.
- Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.
- Ambe PC, Kurz NR, Nitschke C, Odeh SF, Moslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182.
- Fingren J, Lindholm E, Petersen C, Hallen AM, Carlsson E. A Prospective, Explorative Study to Assess Adjustment 1 Year After Ostomy Surgery Among Swedish Patients. Ostomy Wound Manage. 2018 Jun;64(6):12-22.
- Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health-related quality of life of patients with stoma: A descriptive, cross-sectional study. J Clin Nurs. 2019 Aug;28(15-16):2880-2888. doi: 10.1111/jocn.14876. Epub 2019 May 5.
- Temiz Z, Cavdar I, Ozbas A, Altunsoy M, Akyuz N, Kutlu FY. Sleep Quality and Factors Affecting Sleep in Individuals With an Intestinal Ostomy: A Descriptive Cross-Sectional Study. Wound Manag Prev. 2022 May;68(5):28-36. doi: 10.25270/wmp.2022.5.2836.
- Pachler J, Wille-Jorgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004323. doi: 10.1002/14651858.CD004323.pub4.
- Krouse R, Grant M, Ferrell B, Dean G, Nelson R, Chu D. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res. 2007 Mar;138(1):79-87. doi: 10.1016/j.jss.2006.04.033. Epub 2006 Dec 29.
- Cavdar I, Temiz Z, Ozbas A, Can G, Tarhan F, Findik UY, Kutlu FY, Akyuz N. Sleep and quality of life in people with ileal conduit. Scand J Urol. 2016 Dec;50(6):472-476. doi: 10.1080/21681805.2016.1236834. Epub 2016 Oct 5.
- Carlsson E, Berglund B, Nordgren S. Living with an ostomy and short bowel syndrome: practical aspects and impact on daily life. J Wound Ostomy Continence Nurs. 2001 Mar;28(2):96-105. doi: 10.1067/mjw.2001.113261.
- Vorbeck E, Willette-Murphy K, Meiers S, Rudel R, Alakhras M. A descriptive study to assess the impact of surgical stomas on individuals' sleep perceptions & response to sleep hygiene. Ostomy Wound Manage. 2010 Jan 1;56(1):36-44.
- Baldwin CM, Grant M, Wendel C, Hornbrook MC, Herrinton LJ, McMullen C, Krouse RS. Gender differences in sleep disruption and fatigue on quality of life among persons with ostomies. J Clin Sleep Med. 2009 Aug 15;5(4):335-43.
- Furukawa C, Morioka I. Health-Related Quality of Life and Sleep Disorders in Patients With a Urostomy: Is There a Relationship? J Wound Ostomy Continence Nurs. 2017 Jul/Aug;44(4):358-362. doi: 10.1097/WON.0000000000000334.
- Lillehei AS, Halcon LL, Savik K, Reis R. Effect of Inhaled Lavender and Sleep Hygiene on Self-Reported Sleep Issues: A Randomized Controlled Trial. J Altern Complement Med. 2015 Jul;21(7):430-8. doi: 10.1089/acm.2014.0327. Epub 2015 Jun 2.
- Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. doi: 10.1053/smrv.2001.0246.
- Lytle J, Mwatha C, Davis KK. Effect of lavender aromatherapy on vital signs and perceived quality of sleep in the intermediate care unit: a pilot study. Am J Crit Care. 2014 Jan;23(1):24-9. doi: 10.4037/ajcc2014958.
- van der Ploeg ES, Eppingstall B, O'Connor DW. The study protocol of a blinded randomised-controlled cross-over trial of lavender oil as a treatment of behavioural symptoms in dementia. BMC Geriatr. 2010 Jul 22;10:49. doi: 10.1186/1471-2318-10-49.
- Cho MY, Min ES, Hur MH, Lee MS. Effects of aromatherapy on the anxiety, vital signs, and sleep quality of percutaneous coronary intervention patients in intensive care units. Evid Based Complement Alternat Med. 2013;2013:381381. doi: 10.1155/2013/381381. Epub 2013 Feb 17.
- van der Watt G, Janca A. Aromatherapy in nursing and mental health care. Contemp Nurse. 2008 Aug;30(1):69-75. doi: 10.5172/conu.673.30.1.69.
- Karadag E, Samancioglu S, Ozden D, Bakir E. Effects of aromatherapy on sleep quality and anxiety of patients. Nurs Crit Care. 2017 Mar;22(2):105-112. doi: 10.1111/nicc.12198. Epub 2015 Jul 27.
- Ayik C, Ozden D. The effects of preoperative aromatherapy massage on anxiety and sleep quality of colorectal surgery patients: A randomized controlled study. Complement Ther Med. 2018 Feb;36:93-99. doi: 10.1016/j.ctim.2017.12.002. Epub 2017 Dec 6.
- Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.
- Genc F, Karadag S, Kilic Akca N, Tan M, Cerit D. The Effect of Aromatherapy on Sleep Quality and Fatigue Level of the Elderly: A Randomized Controlled Study. Holist Nurs Pract. 2020 May/Jun;34(3):155-162. doi: 10.1097/HNP.0000000000000385.
- Hamzeh S, Safari-Faramani R, Khatony A. Effects of Aromatherapy with Lavender and Peppermint Essential Oils on the Sleep Quality of Cancer Patients: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Mar 25;2020:7480204. doi: 10.1155/2020/7480204. eCollection 2020.
- Bakhtiari S, Paki S, Khalili A, Baradaranfard F, Mosleh S, Jokar M. Effect of lavender aromatherapy through inhalation on quality of life among postmenopausal women covered by a governmental health center in Isfahan, Iran: A single-blind clinical trial. Complement Ther Clin Pract. 2019 Feb;34:46-50. doi: 10.1016/j.ctcp.2018.11.001. Epub 2018 Nov 7.
- Berti-Hearn L, Elliott B. Colostomy Care: A Guide for Home Care Clinicians. Home Healthc Now. 2019 Mar/Apr;37(2):68-78. doi: 10.1097/NHH.0000000000000735.
- Cengiz B, Bahar Z. Perceived Barriers and Home Care Needs When Adapting to a Fecal Ostomy: A Phenomenological Study. J Wound Ostomy Continence Nurs. 2017 Jan/Feb;44(1):63-68. doi: 10.1097/WON.0000000000000271.
- Taylor C, Munro J, Goodman W, Beeken RJ, Dames N, Oliphant R, Watson AJ, Hubbard G. Experiences of wearing support garments by people living with a urostomy. Br J Nurs. 2019 Dec 12;28(22):S26-S33. doi: 10.12968/bjon.2019.28.22.S26.
- Basch E, Foppa I, Liebowitz R, Nelson J, Smith M, Sollars D, Ulbricht C. Lavender (Lavandula angustifolia Miller). J Herb Pharmacother. 2004;4(2):63-78.
- Baxter NN, Novotny PJ, Jacobson T, Maidl LJ, Sloan J, Young-Fadok TM. A stoma quality of life scale. Dis Colon Rectum. 2006 Feb;49(2):205-12. doi: 10.1007/s10350-005-0275-6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-RKOCA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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