Sleep HygieneNCT06583135
Effect of Motivational Interviewing on Sleep Hygiene, Sleep Quality and Quality of Life
A study testing Sleep hygiene education and motivational interviewing and face-to-face sleep hygiene training in people with Sleep Hygiene, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Sleep hygiene education and motivational interviewing have an effect on increasing sleep hygiene in individuals undergoing hemodialysis treatment Sleep hygiene education and motivational interviewing have an effect on increasing sleep quality in individuals undergoing hemodialysis treatment Sleep hygiene education and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Hygiene
- What is being tested?
- Sleep hygiene education and motivational interviewing and face-to-face sleep hygiene training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2024to 10 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hemodialysis at Akdeniz University Hospital
- Having been on a routine hemodialysis program for at least 3 months,
- Having a score of ≥ 26 according to the Sleep Hygiene Index
- Having dialysis adequacy (KT/V and URR values within normal range)
- Being an individual aged 18 and over
- Not having any written or verbal communication barriers
- Being able to use technological devices such as computers, tablets, mobile phones to conduct online motivational interviews
- Being willing to participate in online motivational interviews
Who cannot join
- Having a health problem that affects sleep patterns (sleep apnea, surgical operation (temporary hemodialysis catheter insertion and other surgical procedures, depression, anxiety disorder, etc.)
- Having previously attended any motivational interview session for sleep hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Sleep Hygıene Educatıon And Motıvatıonal Intervıewıng On Sleep Hygıene, Sleep Qualıty And Qualıty Of Lıfe In Hemodıalysıs Patıents: A Randomızed Controlled Trıal
- Sleep hygiene education and motivational interviewing have an effect on increasing sleep hygiene in individuals undergoing hemodialysis treatment
- Sleep hygiene education and motivational interviewing have an effect on increasing sleep quality in individuals undergoing hemodialysis treatment
- Sleep hygiene education and motivational interviewing have an effect on increasing quality of life in individuals undergoing hemodialysis treatment
Read the detailed description
After the pre-tests are applied to the patients in the intervention group, face-to-face sleep hygiene training will be given, and then 4 sessions of motivational interviews will be held within 6 weeks.
The sessions will be conducted online with each patient individually. The post-test will be applied 10 weeks after the pre-test.
- Conditions
- Sleep Hygiene
- Being tested
- Sleep hygiene education and motivational interviewing, face-to-face sleep hygiene training
- Keywords
- Nursing, Hemodialysis, Motivational Interviewing, Sleep Hygiene, Sleep Quality, Quality of Life
- Medical subject headings
- Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene education and motivational interviewingOther
The intervention group, will receive face-to-face sleep hygiene training and then 4 online motivational interviews will be held within 6 weeks. The online motivational interviews will be implemented in the 1st week (interview 1), 2nd week (interview 2), 4th week (interview 3), and 6th week (interview 4).
face-to-face sleep hygiene trainingOther
The control group receive face-to-face sleep hygiene training
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will be given face-to-face sleep hygiene training and and 4 online motivational interviewing will be held within 6 weeks. Receives: Other: Sleep hygiene education and motivational interviewing |
| Control Group | Active comparator | The control group will receive face-to-face sleep hygiene training, routine hemodialysis treatment, and nursing care in the hemodialysis unit. Receives: Other: face-to-face sleep hygiene training |
What is being measured
The primary outcome is the main question the study is designed to answer.
It has the effect of improving sleep hygiene.
The sleep hygiene index is a 5-point Likert-type scale consisting of 13 items, scored from 1 to 5.
A score below 26 indicates good sleep hygiene, and a lower score indicates better sleep hygiene.
Measured: 10 weeks
It is effective in improving sleep quality.
The sleep quality index includes 24 questions consisting of 7 components.
Evaluation, Each item of the scale is evaluated with 0-3 points. Seven "component" scores are created from nineteen items. The last 5 items are not included in the scoring. The total score has a value between 0-21. High values indicate poor sleep quality and high levels of sleep disturbance. A total score of 5 and above indicates poor sleep quality
Measured: 10 weeks
Has an effect on improving the quality of life
The quality of life scale consists of 36 items in 5 sub-dimensions that measure quality of life specific to kidney disease. Scores in each dimension range from 0 to 100, with higher scores indicating better health-related quality of life. A score of "0" indicates the worst health status, while a score of "100" indicates the best health status.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start10 Aug 2024
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep HygieneStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MELEK AVCI, Akdeniz University
- Investigators
- Fatma ARIKAN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583135
- Sponsor's protocol ID
- 2012-KAEK-20-122
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricardo AC, Goh V, Chen J, Cedillo-Couvert E, Kapella M, Prasad B, Parvathaneni S, Knutson K, Lash JP. Association of Sleep Duration, Symptoms, and Disorders with Mortality in Adults with Chronic Kidney Disease. Kidney Int Rep. 2017 Sep;2(5):866-873. doi: 10.1016/j.ekir.2017.05.002. Epub 2017 May 5.
PubMed 29057381Wang R, Tang C, Chen X, Zhu C, Feng W, Li P, Lu C. Poor sleep and reduced quality of life were associated with symptom distress in patients receiving maintenance hemodialysis. Health Qual Life Outcomes. 2016 Sep 8;14(1):125. doi: 10.1186/s12955-016-0531-6.
PubMed 27608683Yang B, Xu J, Xue Q, Wei T, Xu J, Ye C, Mei C, Mao Z. Non-pharmacological interventions for improving sleep quality in patients on dialysis: systematic review and meta-analysis. Sleep Med Rev. 2015 Oct;23:68-82. doi: 10.1016/j.smrv.2014.11.005. Epub 2014 Dec 10.
PubMed 25645131Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the Sleep Hygiene Index. J Behav Med. 2006 Jun;29(3):223-7. doi: 10.1007/s10865-006-9047-6. Epub 2006 Mar 24.
PubMed 16557353
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Sleep Hygıene Educatıon And Motıvatıonal Intervıewıng On Sleep Hygıene, Sleep Qualıty And Qualıty Of Lıfe In Hemodıalysıs Patıents: A Randomızed Controlled Trıal
- ClinicalTrials.gov ID
- NCT06583135
- Acronym / sponsor ID
- 2012-KAEK-20-122
- Conditions
- Sleep Hygiene
- Keywords
- Nursing, Hemodialysis, Motivational Interviewing, Sleep Hygiene, Sleep Quality, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 3 Sep 2024 (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.
- Sleep hygiene education and motivational interviewing have an effect on increasing sleep hygiene in individuals undergoing hemodialysis treatment
- Sleep hygiene education and motivational interviewing have an effect on increasing sleep quality in individuals undergoing hemodialysis treatment
- Sleep hygiene education and motivational interviewing have an effect on increasing quality of life in individuals undergoing hemodialysis treatment
Detailed description
After the pre-tests are applied to the patients in the intervention group, face-to-face sleep hygiene training will be given, and then 4 sessions of motivational interviews will be held within 6 weeks.
The sessions will be conducted online with each patient individually. The post-test will be applied 10 weeks after the pre-test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Sleep hygiene education and motivational interviewingThe intervention group will be given face-to-face sleep hygiene training and and 4 online motivational interviewing will be held within 6 weeks. |
| Control Group | Active comparator | Other: face-to-face sleep hygiene trainingThe control group will receive face-to-face sleep hygiene training, routine hemodialysis treatment, and nursing care in the hemodialysis unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing hemodialysis at Akdeniz University Hospital
- Having been on a routine hemodialysis program for at least 3 months,
- Having a score of ≥ 26 according to the Sleep Hygiene Index
- Having dialysis adequacy (KT/V and URR values within normal range)
- Being an individual aged 18 and over
Key exclusion criteria (2 listed)
- Having a health problem that affects sleep patterns (sleep apnea, surgical operation (temporary hemodialysis catheter insertion and other surgical procedures, depression, anxiety disorder, etc.)
- Having previously attended any motivational interview session for sleep hygiene
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 |
|---|---|---|
| Sleep hygiene education and motivational interviewingThe intervention group, will receive face-to-face sleep hygiene training and then 4 online motivational interviews will be held within 6 weeks. The online motivational interviews will be implemented in the 1st week (interview 1), 2nd week (interview 2), 4th week (interview 3), and 6th week (interview 4). | Other | Intervention Group |
| face-to-face sleep hygiene trainingThe control group receive face-to-face sleep hygiene training | Other | Control Group |
Primary outcome
It has the effect of improving sleep hygiene.
Time frame: 10 weeks
The sleep hygiene index is a 5-point Likert-type scale consisting of 13 items, scored from 1 to 5. A score below 26 indicates good sleep hygiene, and a lower score indicates better sleep hygiene.
It is effective in improving sleep quality.
Time frame: 10 weeks
The sleep quality index includes 24 questions consisting of 7 components. Evaluation, Each item of the scale is evaluated with 0-3 points. Seven "component" scores are created from nineteen items. The last 5 items are not included in the scoring. The total score has a value between 0-21. High values indicate poor sleep quality and high levels of sleep disturbance. A total score of 5 and above indicates poor sleep quality
Has an effect on improving the quality of life
Time frame: 10 weeks
The quality of life scale consists of 36 items in 5 sub-dimensions that measure quality of life specific to kidney disease. Scores in each dimension range from 0 to 100, with higher scores indicating better health-related quality of life. A score of "0" indicates the worst health status, while a score of "100" indicates the best health status.
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 3 Dec 2025.
- Results publication: PubMed 29057381Ricardo AC, Goh V, Chen J, Cedillo-Couvert E, Kapella M, Prasad B, Parvathaneni S, Knutson K, Lash JP. Association of Sleep Duration, Symptoms, and Disorders with Mortality in Adults with Chronic Kidney Disease. Kidney Int Rep. 2017 Sep;2(5):866-873. doi: 10.1016/j.ekir.2017.05.002. Epub 2017 May 5.
- Results publication: PubMed 27608683Wang R, Tang C, Chen X, Zhu C, Feng W, Li P, Lu C. Poor sleep and reduced quality of life were associated with symptom distress in patients receiving maintenance hemodialysis. Health Qual Life Outcomes. 2016 Sep 8;14(1):125. doi: 10.1186/s12955-016-0531-6.
- Results publication: PubMed 25645131Yang B, Xu J, Xue Q, Wei T, Xu J, Ye C, Mei C, Mao Z. Non-pharmacological interventions for improving sleep quality in patients on dialysis: systematic review and meta-analysis. Sleep Med Rev. 2015 Oct;23:68-82. doi: 10.1016/j.smrv.2014.11.005. Epub 2014 Dec 10.
- Results publication: PubMed 16557353Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the Sleep Hygiene Index. J Behav Med. 2006 Jun;29(3):223-7. doi: 10.1007/s10865-006-9047-6. Epub 2006 Mar 24.
- 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.
Fatma ARIKAN study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene education and motivational interviewing and face-to-face sleep hygiene training in people with Sleep Hygiene, run by Akdeniz 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 8 inclusion and 2 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 3 Dec 2025. 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?
It has the effect of improving sleep hygiene. (time frame: 10 weeks). 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 NCT06583135, which also lists 4 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 3 Dec 2025.