THE EFFECTS OF CIRCADIAN RHYTHM-BASED PROGRESSIVE RELAXATION EXERCISES IN HEMODIALYSIS PATIENTS

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07499297

Enrollment

Registered

2026-03-30

Start date

2026-04-01

Completion date

2026-09-22

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm, Hemodialysis Patient, Nursing, Relaxation Exercise, Symptom Management

Keywords

Nursing, hemodialysis, circadian rhythm, relaxation exercise, symptom management, sleep quality, comfort, mental well-being

Brief summary

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.

Interventions

OTHERProgressive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
The Morningness-Eveningness Questionnaire	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	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	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	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	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026