OstomyMU-RKOCA-01NCT05573256
Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life
A study testing Lavender oil inhalation and Sleep hygiene education in people with Ostomy, run by Marmara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ostomy
- What is being tested?
- Lavender oil inhalation and Sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ostomy
- Being tested
- Lavender oil inhalation, Sleep hygiene education
- Keywords
- Ostomy, Sleep Hygiene, Lavander oil, Sleep, Fatigue, Quality of Life
- Medical subject headings
- Sleep Hygiene, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender oil inhalationBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Sleep hygiene education together with lavender oil inhalation) | Experimental | 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. Receives: Behavioral: Lavender oil inhalation; Behavioral: Sleep hygiene education |
| Group 2 (Sleep hygiene education) | Experimental | 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. Receives: Behavioral: Sleep hygiene education |
| Group 3 (Lavender oil inhalation) | Experimental | 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. Receives: Behavioral: Lavender oil inhalation |
| Group 4 (Routine care) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: a month
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.
Measured: a month
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.
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start14 Jun 2022
- Primary completion14 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Koca, Principal investigator, Marmara University, Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573256
- Sponsor's protocol ID
- MU-RKOCA-01
- Acronym
- MU-RKOCA-01
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29607805Fingren 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.
PubMed 30059344Zhang 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.
PubMed 30939212Temiz 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.
PubMed 35617011Pachler 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.
PubMed 23235607Krouse 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.
PubMed 17196990Cavdar 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.
PubMed 27701970Carlsson 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.
PubMed 11248730Vorbeck 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.
PubMed 20093716Baldwin 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.
PubMed 19968011Furukawa 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.
PubMed 28549047Lillehei 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.
PubMed 26133206Stepanski 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.
PubMed 12927121Lytle 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.
PubMed 24382614van 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.
PubMed 20649945
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05573256
- Acronym / sponsor ID
- MU-RKOCA-01 / MU-RKOCA-01
- Conditions
- Ostomy
- Keywords
- Ostomy, Sleep Hygiene, Lavander oil, Sleep, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Sleep hygiene education together with lavender oil inhalation) | Experimental | Behavioral: Lavender oil inhalation, Behavioral: Sleep hygiene educationthe 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. |
| Group 2 (Sleep hygiene education) | Experimental | Behavioral: Sleep hygiene educationThe 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. |
| Group 3 (Lavender oil inhalation) | Experimental | Behavioral: Lavender oil inhalationThe 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. |
| Group 4 (Routine care) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender oil inhalationLavender 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. | Behavioural | Group 1 (Sleep hygiene education together with lavender oil inhalation), Group 3 (Lavender oil inhalation) |
| Sleep hygiene educationSleep 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. | Behavioural | Group 1 (Sleep hygiene education together with lavender oil inhalation), Group 2 (Sleep hygiene education) |
Primary outcome
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'.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 29607805Ambe 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.
- Background: PubMed 30059344Fingren 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.
- Background: PubMed 30939212Zhang 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.
- Background: PubMed 35617011Temiz 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.
- Background: PubMed 23235607Pachler 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.
- Background: PubMed 17196990Krouse 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.
- Background: PubMed 27701970Cavdar 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.
- Background: PubMed 11248730Carlsson 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.
- Background: PubMed 20093716Vorbeck 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.
- Background: PubMed 19968011Baldwin 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.
- Background: PubMed 28549047Furukawa 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.
- Background: PubMed 26133206Lillehei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Koca principal investigator
Marmara University, Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender oil inhalation and Sleep hygiene education in people with Ostomy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: a month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573256, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.