- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06583135
Effect of Motivational Interviewing on Sleep Hygiene, Sleep Quality and Quality of Life
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
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melek AVCI
- Phone Number: +902422272863 2422272863
- Email: mlkavc07@gmail.com
Study Locations
-
-
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Antalya, Turkey
- Recruiting
- Akdeniz University Hospital
-
Contact:
- Melek AVCI
- Phone Number: 2863 +902422274400
- Email: mlkavc07@gmail.com
-
Contact:
- Fatma ARIKAN
- Phone Number: 6114 +902422274400
- Email: farikan64@gmail.com
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Principal Investigator:
- Melek AVCI
-
Antalya, Turkey
- Recruiting
- Antalya Training and Research Hospital
-
Contact:
- Melek AVCI
- Phone Number: +902422272863
- Email: mlkavc07@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing hemodialysis at Akdeniz University Hospital and Antalya Training and Research 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
The intervention group will be given face-to-face sleep hygiene training and and 4 online motivational interviewing will be held within 6 weeks.
|
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).
|
Active Comparator: Control Group
The control group will receive face-to-face sleep hygiene training, routine hemodialysis treatment, and nursing care in the hemodialysis unit.
|
The control group receive face-to-face sleep hygiene training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
10 weeks
|
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 |
10 weeks
|
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.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fatma ARIKAN, Akdeniz University
Publications and helpful links
General 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.
- Wang 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.
- Yang 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.
- Mastin 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2012-KAEK-20-122
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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