Measuring Sleep Quality With Puki in Hemodialysis Patients Performing Progressive Muscle Relaxant Exercises

NCT05604833 | Completed

• 1 other identifier: KARATAY.halime.hakverir1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease is a chronic disease that negatively affects the quality of life of individuals, physically, socially and psychologically. Although the problems due to kidney failure are brought under control with hemodialysis treatment, the continuation of the treatment depending on the machine and the difficulties brought by the treatment process cause the patient to experience many negativities, especially insomnia and fatigue. Studies have shown that the prevalence of insomnia in patients receiving hemodialysis treatment is high and sleep problems are seen in 40-83% of them, the quality of sleep is low, and the quality of life is adversely affected by this situation, and the mortality rate increases. This study will be conducted to evaluate the effect of progressive muscle relaxation exercises on sleep quality applied to individuals receiving hemodialysis treatment for chronic kidney disease (CKD) and having poor sleep quality. The research will be conducted as a randomized controlled trial with patients receiving hemodialysis treatment at Private Nephrotrans Karatay Dialysis Center between March and September 2022. The sample size of the study was determined according to the results of a similar study using the G\*Power 3.1., 9.7 program with α = 0.05 and 90% power. The sample number was determined as 80 patients, including experimental (n=40) and control (n=40). In the research, data will be collected with the "Descriptive Information Form" and "Pittsburgh Sleep Quality Index (PUKI)". Statistical analysis of the data obtained as a result of the research will be made in the IBM SPSS25 program. This study was planned because it is thought that making progressive muscle relaxation exercises (PKGE) in patients with poor sleep quality who receive hemodialysis treatment will be effective in increasing sleep quality, since it is easy to learn, can be done anywhere, and has no side effects.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  measuring the effect of progressive November relaxation exercise on sleep quality

  two months

Study Arms (2)

experimental

EXPERIMENTAL

they will November progressive muscle relaxation exercise

Behavioral: Progressive Muscle Relaxation Exercises

no ıntervention

NO INTERVENTION

to be followed without exercise

Interventions

Progressive Muscle Relaxation Exercises BEHAVIORAL

In the research, data will be collected with the "Descriptive Information Form" and "Pittsburgh Sleep Quality Index (PUKI)". Statistical analysis of the data obtained as a result of the research will be made in the IBM SPSS25 program. This study was planned because it is thought that making progressive muscle relaxation exercises (PKGE) in patients with poor sleep quality who receive hemodialysis treatment will be effective in increasing sleep quality, since it is easy to learn, can be done anywhere, and has no side effects.

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who are 18 years of age or older, \*
• Pittsburgh Sleep Quality Index (PUKI) score of 5 points and above,
• Who has been receiving hemodialysis treatment for at least 3 months,
• Convenient to upload progressive November muscle relaxation exercise video to the mobile phone located
• Who volunteered to participate in the research

You may not qualify if:

• Hearing impaired
• Who has a physical disability to perform relaxation exercises
• Depression, schizophrenia, etc. with a diagnosis of psychiatric illness
• Relaxation exercise (yoga, breathing and meditation, etc.) for the last six months.) acting

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay Üniversitesi

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding Due to the characteristics of the study, blinding cannot be applied to the participants. In order to eliminate the bias, the data of the study will be collected and recorded by an impartial researcher (assistant researcher) who does not know the groups trained by the researcher. The statistics of the research will be carried out by an independent statistician who does not know the groups. In this way, the prevention of bias will be ensured. The implementation phase of the research is indicated in Table 1 The Implementation Phases of the Research and the Consort diagram (Figure 1. Consort Scheme).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Controlled Study

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 3, 2022
• Study Start: October 31, 2022
• Primary Completion: February 7, 2023
• Study Completion: April 10, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

TU (1)