Not yet recruiting NCT07499297

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

No phase Interventional Nursing Hemodialysis Patient Circadian Rhythm Relaxation Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Progressive Relaxation Exercises.
Who it may be relevant to: Registry conditions: Nursing, Hemodialysis Patient, Circadian Rhythm, Relaxation Exercise. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Other 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.

Primary outcome measures

The Morningness-Eveningness Questionnaire [Time frame: Preprocedural]
Dialysis Symptom Index [Time frame: Periprocedural]
Hemodialysis Comfort Scale-Version II [Time frame: Periprocedural]
Pittsburg Sleep Quality Index [Time frame: Periprocedural]
Warwick-Edinburgh Mental Well-Being Scale [Time frame: Periprocedural]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07499297 · ETHICHS ID: 2024/259 · 225S904

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗