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NCT Number: NCT07061353

Effect of Therapeutic Touch on Perceived Stress and Comfort Levels in Hemodialysis Patients

Hemodialysis is a treatment method used in the treatment of acute or chronic renal failure, the main function of which is based on the cleaning of accumulated waste materials in the blood, and is rapidly developing and spreading in parallel with today's technology. Patients undergoing hemodialysis treatment are trying to cope with social and physical problems that may develop due to chronic disease. At the same time, their quality of life is affected due to the psychosocial, economic problems and complications brought about by machine dependency. From past to present, individuals have used various methods to protect/improve their health. Today, in addition to modern medicine, complementary/alternative therapies are increasingly used. One of these alternative therapies is the therapeutic touch application, which has recently gained popularity. Therapeutic touch is based on the therapeutic effect of the act of touching. Therapeutic touch, alternatively known as healing touch, is a complementary/alternative treatment method applied by touching energy points in the body. Therefore, this study was planned to examine the effect of therapeutic touch applied to hemodialysis patients on perceived stress and comfort levels. This study, planned as a randomized experimental study with a pre-test-post-test intervention control group, will be a study on dialysis patients receiving treatment at the hemodialysis unit of Fırat University Hospital between June 2025-June 2026. The sample will consist of a minimum of 60 dialysis patients (30 intervention, 30 control) who meet the research criteria and accept the study. The patients in the intervention and control groups will first be informed about the application before starting the application and their verbal and written consents will be obtained. Then, the Patient Identification Form, Visual Analog Scale-Comfort (VAS-Comfort), Hemodialysis Comfort Scale (HKS) and Perceived Stress Scale (PSS) will be applied and the 1st measurement will be obtained. The application will last approximately 15-30 minutes for the patients in the intervention group every three days. After three days of alternate application, data forms will be filled in again for patients and 2nd measurements will be obtained. During this period, no intervention will be made to patients in the control group and only the normal treatment protocol will be applied. At the end of three days, data forms will be filled in again and 2nd measurements will be obtained. In the analysis of data; frequency and percentage analyses, chi-square analysis, standard deviation, t-test in dependent groups, t-test analysis in independent groups will be performed.

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Key information

Conditions

Therapeutic Touch Hemodialysis Patients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 3 months of hemodialysis treatment • Cognitive function is in place

Exclusion criteria

  • Those with communication problems
  • Those who do not agree to participate in the study
  • Patients who receive traditional treatment for the disease

Treatment and study plan

Therapeutic Touch

Behavioral

Therapeutic touch will be performed

Primary outcomes

  1. Visual Analog Scale - Comfort

    Time frame: At the end of the third day

    The Visual Analog Scale was developed by Price et al. (1983) to assess pain intensity. In previous studies, VAS was also used to determine the comfort levels of patients. In this study, VAS was used to assess the comfort levels of patients. A score of 0 on the scale for comfort assessment indicates "I have no comfort at all", and a score of 10 indicates "I have great comfort".

  2. Hemodialysis Comfort Scale

    Time frame: At the end of the third day

    The scale, developed by Şahin Orak and colleagues (2017) to determine the comfort levels of hemodialysis patients, consists of 9 items and two sub-dimensions. The responses to item 4 of the scale are scored as "never" 1 point, "very rarely" 2 points, "sometimes" 3 points, "very often" 4 points and "always" 5 points. The scores given to the other items (1-3, 5-9) are scored in reverse: "never" 5 points, "very rarely" 4 points, "sometimes" 3 points, "very often" 2 points and "always" 1 point. The scale has two sub-dimensions: "Relaxation" (items 7-9) and "Overcoming" (items 1-6). The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score. The increase in the total score obtained from the scale indicates that the comfort level increases. In the validity and reliability study of the developed scale, the Cronbach alpha value for the total scale was determined as 0.87.

  3. Perceived Stress Scale

    Time frame: At the end of the third day

    The Perceived Stress Scale was developed by Cohen et al. in 1983 to determine the level of stress that threatens human health. Its Turkish validity and reliability were determined by Eskin et al. (2013). The scale consists of 2 factors: "insufficient self-efficacy" and "stress" perception. The scale is a 5-point Likert-type scale and consists of 14 items. As the scores obtained from the scale increase, the stress level perceived by the person also increases. PSS scores range from 0 to 56, with a score range of 0-35 indicating a normal stress level and a score range of 35-56 indicating that the individual is under stress. In the original study of the scale, the Cronbach Alpha coefficient was found to be 0.84

Study contacts

Contact information is provided by the study sponsor or research team.

Eda Doğan

CONTACT

0534 014 2159

Gülcan Bahçecioğlu Turan

CONTACT

[email protected]

05065576086

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

Effect of Therapeutic Touch on Perceived Stress and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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