beta
Trial Radar AI
Clinical Trial NCT07499297 for Nursing, Hemodialysis Patient, Circadian Rhythm, Relaxation Exercise, Symptom Management is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View

THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES IN HEMODIALYSİS PATIENTS 75 Randomized Double-Blind Exercise-Based

Not yet recruiting
Clinical Trial NCT07499297 is an interventional study for Nursing, Hemodialysis Patient, Circadian Rhythm, Relaxation Exercise, Symptom Management and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 75 participants. Led by Karamanoğlu Mehmetbey University, this study is expected to complete by September 22, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
The aim of this study is to determine the effect of Progressive Relaxation Exercise (PGE) applied according to the circadian rhythms of hemodialysis (HD) patients on symptom management, sleep quality, comfort and mental well-being levels and to examine the experiences of HD patients regarding PGE application. A sequential mixed method research design will be used in the study. The quantitative part of the study was p...Show More
Detailed Description
The aim of this study is to determine the effect of Progressive Relaxation Exercise (PGE) applied according to the circadian rhythms of hemodialysis (HD) patients on symptom management, sleep quality, comfort and mental well-being levels and to examine the experiences of HD patients regarding PGE application. A sequential mixed method research design will be used in the study. The quantitative part of the study was p...Show More
Official Title

THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES ON SYMPTOM MANAGEMENT, SLEEP QUALITY, COMFORT, AND MENTAL WELL-BEING IN HEMODIALYSIS PATIENTS

Conditions
NursingHemodialysis PatientCircadian RhythmRelaxation ExerciseSymptom Management
Other Study IDs
  • ETHICHS ID: 2024/259
  • 873565 (Other Grant/Funding Number) (THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKIYE (TÜBİTAK))
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-09-22
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Nursing
hemodialysis
circadian rhythm
relaxation exercise
symptom management
sleep quality
comfort
mental well-being
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention 1
The group in harmony with the circadian rhythm; according to the results of the Morningness-Eveningness Questionnaire, the application time for morning types will be planned between 08:00-10:00, while for evening types it will be planned between 20:00-22:00.
Progressive Relaxation Exercises
Progressive relaxation exercises (PRE) begin with deep breathing exercises that facilitate relaxation and continue with muscle tension-relaxation exercises. Individuals in the intervention group will perform PRE for 30 minutes each day, accompanied by the video, at times.
ExperimentalIntervention 2
The group is not in harmony with the circadian rhythm; according to the results of the Morningness-Eveningness Questionnaire, the application times for evening types will be planned between 08:00-10:00, while for morning types they will be planned between 20:00-22:00.
Progressive Relaxation Exercises
Progressive relaxation exercises (PRE) begin with deep breathing exercises that facilitate relaxation and continue with muscle tension-relaxation exercises. Individuals in the intervention group will perform PRE for 30 minutes each day, accompanied by the video, at times.
No InterventionControl
No intervention will be applied to the individuals in this group for 8 weeks.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The Morningness-Eveningness Questionnaire
The Morningness-Eveningness Questionnaire (MEQ) consists of 19 items. Fourteen of these items are multiple-choice questions, while the remaining five items include time-scale questions in which participants are asked to mark the time point most appropriate for them. Participants receive a score based on their responses to each of the 19 items, and the total MEQ score is obtained by summing these scores. Lower MEQ scores are associated with the evening chronotype, whereas higher scores are associated with the morning chronotype. Finally, individuals are classified into five different chronotype groups based on their MEQ scores: definitely evening type, moderately evening type, neither type, moderately morning type, and definitely morning type. This questionnaire will be used to determine the morningness-eveningness chronotypes of the patients.
Preprocedural
Dialysis Symptom Index
The scale includes 30 symptoms describing physical or emotional conditions. Patients respond to the symptoms they have experienced during the past week as yes or no, where "no" indicates that the symptom was not experienced and "yes" indicates that the symptom was experienced. If the response is "yes," the degree to which the symptom affects the patient is evaluated using a five-point Likert-type scale, ranging from 1 (not at all) to 5 (very much). After summing the scores obtained, the total scale score is calculated. The total score ranges between 0 and 150, with scores closer to 150 indicating a greater impact of symptoms. This scale will be used to assess the dialysis symptoms and their severity in patients.
Periprocedural
Hemodialysis Comfort Scale-Version II
This scale is a 5-point Likert-type instrument consisting of 26 items and six subdimensions: physical relief, physical ease, psychospiritual relief, psychospiritual transcendence, environmental transcendence, and sociocultural relief. As the scale score increases, the level of comfort increases, whereas lower scores indicate a lower level of comfort. The total scale score ranges from 26 to 130. This scale will be used to evaluate the comfort levels of the patients.
Periprocedural
Pittsburg Sleep Quality Index
The index, which evaluates sleep patterns over the past month, consists of 19 items and 7 components. Eighteen of the items included in the index scoring are grouped into seven component scores. These components assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is scored on a 0-3 scale, and the sum of the seven component scores yields the total Pittsburgh Sleep Quality Index (PSQI) score. The total PSQI score ranges from 0 to 21, obtained by summing the subscale scores. A total PSQI score greater than five indicates poor sleep quality, with 89.6% sensitivity and 86.5% specificity, and suggests severe impairment in at least two areas or moderate impairment in three areas mentioned above. This scale will be used to evaluate the sleep quality of the patients.
Periprocedural
Warwick-Edinburgh Mental Well-Being Scale
The scale consists of 14 items and is a 5-point Likert-type instrument scored as follows: 1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, and 5 = strongly agree. There are no reverse-scored items in the scale. The minimum possible score is 14, and the maximum possible score is 70. This scale will be used to assess the mental well-being levels of the patients.
Periprocedural
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 18 and 65 years of age,
  • have no mental or physical disabilities that would prevent them from answering the questions,
  • have no problems related to touch, temperature perception, hearing, or vision,
  • are relatively independent in performing daily activities,
  • do not use any pharmacological or non-pharmacological methods to facilitate sleep,
  • have been receiving hemodialysis (HD) treatment for at least 3 months,
  • are able to communicate and cooperate.

  • are bedridden,
  • have physical limitations preventing them from performing relaxation exercises,
  • have been practicing relaxation exercises (such as breathing exercises, meditation, yoga, etc.) within the last 6 months,
  • are classified as intermediate type (neither type) according to the Morningness-Eveningness Questionnaire,
  • engage in regular exercise,
  • have been diagnosed with psychiatric disorders such as depression or schizophrenia,
  • do not consent to participate in the study.
Karamanoğlu Mehmetbey University logoKaramanoğlu Mehmetbey University
Study Responsible Party
Ayşegül Topuz, Principal Investigator, Lecturer, Karamanoğlu Mehmetbey University
No contact data.