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

NCT07499297 | Not Yet Recruiting

• 2 other identifiers: ETHICHS ID: 2024/259225S904
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

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.

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.

Other: Progressive Relaxation Exercises

Control

NO INTERVENTION

No intervention will be applied to the individuals in this group for 8 weeks.

Interventions

Progressive Relaxation Exercises OTHER

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.

Intervention 1; Intervention 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share