Effects of Virtual Reality and Breathing Exercises on Hemodialysis Patients' Symptoms and Quality of Life

NCT06968130 | Active Not Recruiting

• 1 other identifier: TÜTF-BAEK-2021/01
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aims to examine the effects of virtual reality glasses and breathing exercises on symptoms and quality of life in patients receiving hemodialysis treatment. Design: This randomized controlled cross-sectional study will be conducted in the hemodialysis units of 3 state and 2 private hospitals. Individuals over 18 years old, diagnosed with End-Stage Renal Disease (ESRD), on hemodialysis for at least 3 months, without communication barriers, and volunteering to participate will be included. A power analysis using G\*Power (v3.1.7) determined a sample size of 53 individuals per group for 80% power at α=0.05. Data will be collected through a demographic questionnaire, Dialysis Symptom Index (DSI), and WHOQOL-Bref-TR, with permission obtained from scale developers. Participants will be randomized into three groups: Experiment 1 (Virtual Reality Group): After completing the initial scales, patients will watch a 20-minute nature simulation via virtual reality glasses before and after hemodialysis. This will be repeated in two follow-up sessions one week apart, followed by scale administration. Experiment 2 (Breathing Exercise Group): Patients will perform deep breathing exercises guided by the researcher: 1 minute normal breathing, 3 minutes chest breathing, 3 minutes diaphragmatic breathing, 2 minutes pursed-lip breathing, and 1 minute normal breathing. Exercises will be conducted for 10 minutes before and after hemodialysis, repeated in two follow-up sessions one week apart, with post-session scale completion. Control Group: Patients will receive routine hemodialysis without any additional intervention. The same scales will be administered at baseline and during two follow-ups one week apart. Statistics: Data analysis will be performed using Statistical Package for the Social Sciences (SPSS) Software. Descriptive statistics (mean, standard deviation, median, frequency, ratio) will be used. The Shapiro-Wilk test and box plot graphics will assess normality. For comparisons: ANOVA, Kruskal-Wallis H test, Tukey's post-hoc test, Pearson's chi-square test, Fisher's exact chi-square test, Bonferroni test, and multiple regression model analyses. Significance will be set at p\<0.05.

Conditions

Kidney Diseases

Keywords

Hemodialysis; quality of life; general assessment of symptoms; virtual reality; breathing exercise

Outcome Measures

Primary Outcomes (1)

• Dialysis Symptom Index (DSI)

  It was developed by Hemodialysis patients in order to determine the symptoms experienced by Hemodialysis patients and the level of impact on the patient. The scale, developed from the Memorial Symptom Diagnosis Scale Short Form, consists of 30 items. Responses are obtained on a 5-point Likert scale. The total scale score is obtained by adding up the scores obtained. This value varies between "0-15 0". The value "0" indicates that there is no symptom. The increase in the total points given to the answers towards 150 points shows that the effect of the mentioned symptom is increasing. The internal consistency coefficient of the scale was determined as 0.84.

  This form was completed by each patient three times in total, at one-week intervals

Secondary Outcomes (1)

• World Health Organization Quality of Life - Bref

  This form was completed by each patient three times in total, at one-week intervals

Study Arms (3)

control group

SHAM COMPARATOR

Patients will receive routine hemodialysis without any additional intervention. The same scales will be administered at baseline and during two follow-ups one week apart.

Behavioral: routine hemodialysis

Breathing Exercise Group

ACTIVE COMPARATOR

Patients will perform deep breathing exercises guided by the researcher: 1 minute normal breathing, 3 minutes chest breathing, 3 minutes diaphragmatic breathing, 2 minutes pursed-lip breathing, and 1 minute normal breathing. Exercises will be conducted for 10 minutes before and after hemodialysis, repeated in two follow-up sessions one week apart, with post-session scale completion.

Behavioral: routine hemodialysis; Behavioral: Breathing Exercise

Virtual Reality Group

ACTIVE COMPARATOR

After completing the initial scales, patients will watch a 20-minute nature simulation via virtual reality glasses before and after hemodialysis. This will be repeated in two follow-up sessions one week apart, followed by scale administration.

Behavioral: routine hemodialysis; Device: Virtual Reality

Interventions

routine hemodialysis BEHAVIORAL

Patients will receive routine hemodialysis without any additional intervention. The same scales will be administered at baseline and during two follow-ups one week apart.

Breathing Exercise Group; Virtual Reality Group; control group

Breathing Exercise BEHAVIORAL

Patients will perform deep breathing exercises guided by the researcher: 1 minute normal breathing, 3 minutes chest breathing, 3 minutes diaphragmatic breathing, 2 minutes pursed-lip breathing, and 1 minute normal breathing. Exercises will be conducted for 10 minutes before and after hemodialysis, repeated in two follow-up sessions one week apart, with post-session scale completion.

Breathing Exercise Group

Virtual Reality DEVICE

After completing the initial scales, patients will watch a 20-minute nature simulation via virtual reality glasses before and after hemodialysis. This will be repeated in two follow-up sessions one week apart, followed by scale administration.

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

• Being over 18 years old,
• Being diagnosed with ESRD,
• Being on hemodialysis for at least 3 months,
• Not having any sensory loss related to vision or hearing,
• Not having a psychiatric disease,
• Being open to communication and cooperation,
• Being willing to participate in the research

You may not qualify if:

• Being under 18 years of age,
• Not being in the end stage of chronic kidney disease,
• Receiving hemodialysis treatment for less than 3 months,
• Having sensory loss related to vision and hearing,
• Having a psychiatric disease,
• Not being open to communication and cooperation,
• Not volunteering to participate in the research

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Kırklareli Eğitim ve Araştırma Hastanesi

Kırklareli, Merkez, 39010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ecehan Bulut

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 13, 2025
• Study Start: August 1, 2021
• Primary Completion: May 15, 2025
• Study Completion: July 28, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)