NCT06583135

Brief 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 motivational interviewing have an effect on increasing quality of life in individuals undergoing hemodialysis treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

August 31, 2024

Last Update Submit

December 1, 2025

Conditions

Keywords

NursingHemodialysisMotivational InterviewingSleep HygieneSleep QualityQuality of Life

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    10 weeks

Study Arms (2)

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.

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.

Other: face-to-face sleep hygiene training

Interventions

The control group receive face-to-face sleep hygiene training

Control Group

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).

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Sleep HygieneSleep Initiation and Maintenance Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Fatma ARIKAN

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only participant masking was performed
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a parallel group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2024

First Posted

September 3, 2024

Study Start

August 10, 2024

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations