NursingNCT07499297
THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES IN HEMODIALYSIS PATIENTS
A study testing Progressive Relaxation Exercises in people with Nursing and Hemodialysis Patient, run by Karamanoğlu Mehmetbey University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nursing, Hemodialysis Patient, Circadian Rhythm
- What is being tested?
- Progressive Relaxation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 22 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES ON SYMPTOM MANAGEMENT, SLEEP QUALITY, COMFORT, AND MENTAL WELL-BEING IN HEMODIALYSIS PATIENTS
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 planned as a randomized controlled double-blind experimental study. The qualitative part will be conducted as a qualitative research to be carried out with individual in-depth interview method in order to examine the opinions of the individuals in the intervention group regarding the 8-week PGE applied according to the circadian rhythm. In the collection of research data, the Introductory Information Form, Morningness-Eveningness Questionnaire (MEQ), Dialysis Symptom Index, Hemodialysis Comfort Scale - Version II, Pittsburg Sleep Quality Index (PSQI), Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ), Individual Follow-up Form, Progressive Relaxation Exercise Application Guideline (PGEUY) and In-Depth Interview Form with Individuals in the Intervention Group will be used.
Read the 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 planned as a randomized controlled double-blind experimental study. The qualitative part will be conducted as a qualitative research to be carried out with individual in-depth interview method in order to examine the opinions of the individuals in the intervention group regarding the 8-week PGE applied according to the circadian rhythm. In the collection of research data, the Introductory Information Form, Morningness-Eveningness Questionnaire (MEQ), Dialysis Symptom Index, Hemodialysis Comfort Scale - Version II, Pittsburg Sleep Quality Index (PSQI), Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ), Individual Follow-up Form, Progressive Relaxation Exercise Application Guideline (PGEUY) and In-Depth Interview Form with Individuals in the Intervention Group will be used. According to the results of the Morningness-Eveningness Questionnaire; A PGE application schedule will be created for individuals in the Intervention I group at 08:00-10:00 for morning cravings and 20:00-22:00 for evening cravings. In the Intervention II group, the same schedule will be created for morning cravings at 20:00-22:00 and for evening cravings at 08:00-10:00. Individuals in the intervention groups will be asked to apply PGE at the specified times every day for 8 weeks. After all applications are completed, Dialysis Symptom Index, Hemodialysis Comfort Scale-Version II, PUKI, and WEMİOÖ will be applied to the individuals again by the scholarship holder. No application will be made to the individuals in the control group for 8 weeks.
- Being tested
- Progressive Relaxation Exercises
- Keywords
- Nursing, hemodialysis, circadian rhythm, relaxation exercise, symptom management, sleep quality, comfort, mental well-being
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | 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. Receives: Other: Progressive Relaxation Exercises |
| Intervention 2 | Experimental | 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. Receives: Other: Progressive Relaxation Exercises |
| Control | No intervention | No intervention will be applied to the individuals in this group for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Topuz, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499297
- Sponsor's protocol ID
- ETHICHS ID: 2024/259
- Other IDs
- 225S904
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES ON SYMPTOM MANAGEMENT, SLEEP QUALITY, COMFORT, AND MENTAL WELL-BEING IN HEMODIALYSIS PATIENTS
- ClinicalTrials.gov ID
- NCT07499297
- Acronym / sponsor ID
- ETHICHS ID: 2024/259
- Keywords
- Nursing, hemodialysis, circadian rhythm, relaxation exercise, symptom management, sleep quality, comfort, mental well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 30 Mar 2026 (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.
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 planned as a randomized controlled double-blind experimental study. The qualitative part will be conducted as a qualitative research to be carried out with individual in-depth interview method in order to examine the opinions of the individuals in the intervention group regarding the 8-week PGE applied according to the circadian rhythm. In the collection of research data, the Introductory Information Form, Morningness-Eveningness Questionnaire (MEQ), Dialysis Symptom Index, Hemodialysis Comfort Scale - Version II, Pittsburg Sleep Quality Index (PSQI), Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ), Individual Follow-up Form, Progressive Relaxation Exercise Application Guideline (PGEUY) and In-Depth Interview Form with Individuals in the Intervention Group will be used.
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 planned as a randomized controlled double-blind experimental study. The qualitative part will be conducted as a qualitative research to be carried out with individual in-depth interview method in order to examine the opinions of the individuals in the intervention group regarding the 8-week PGE applied according to the circadian rhythm. In the collection of research data, the Introductory Information Form, Morningness-Eveningness Questionnaire (MEQ), Dialysis Symptom Index, Hemodialysis Comfort Scale - Version II, Pittsburg Sleep Quality Index (PSQI), Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ), Individual Follow-up Form, Progressive Relaxation Exercise Application Guideline (PGEUY) and In-Depth Interview Form with Individuals in the Intervention Group will be used. According to the results of the Morningness-Eveningness Questionnaire; A PGE application schedule will be created for individuals in the Intervention I group at 08:00-10:00 for morning cravings and 20:00-22:00 for evening cravings. In the Intervention II group, the same schedule will be created for morning cravings at 20:00-22:00 and for evening cravings at 08:00-10:00. Individuals in the intervention groups will be asked to apply PGE at the specified times every day for 8 weeks. After all applications are completed, Dialysis Symptom Index, Hemodialysis Comfort Scale-Version II, PUKI, and WEMİOÖ will be applied to the individuals again by the scholarship holder. No application will be made to the individuals in the control group for 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Other: Progressive Relaxation ExercisesThe 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. |
| Intervention 2 | Experimental | Other: Progressive Relaxation ExercisesThe 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. |
| Control | No intervention | –No intervention will be applied to the individuals in this group for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Progressive Relaxation ExercisesProgressive 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. | Other | Intervention 1, Intervention 2 |
Primary outcome
The Morningness-Eveningness Questionnaire
Time frame: Preprocedural
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.
Dialysis Symptom Index
Time frame: Periprocedural
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.
Hemodialysis Comfort Scale-Version II
Time frame: Periprocedural
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.
Pittsburg Sleep Quality Index
Time frame: Periprocedural
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.
Warwick-Edinburgh Mental Well-Being Scale
Time frame: Periprocedural
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises in people with Nursing and Hemodialysis Patient, run by Karamanoğlu Mehmetbey University.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The Morningness-Eveningness Questionnaire (time frame: Preprocedural). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.