Therapeutic TouchNCT07061353
Effect of Therapeutic Touch on Perceived Stress and Comfort Levels in Hemodialysis Patients
A study testing Therapeutic touch in people with Therapeutic Touch and Hemodialysis Patients, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Touch, Hemodialysis Patients
- What is being tested?
- Therapeutic touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 3 months of hemodialysis treatment • Cognitive function is in place
Who cannot join
- Those with communication problems
- Those who do not agree to participate in the study
- Patients who receive traditional treatment for the disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eda Doğan contact
About this study
Official title: Effect of Therapeutic Touch on Perceived Stress and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial
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.
- Conditions
- Therapeutic Touch, Hemodialysis Patients
- Being tested
- Therapeutic touch
- Keywords
- Therapeutic touch, Hemodialysis Patient, Stress, Comfort, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic touchBehavioural
Therapeutic touch will be performed
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Touch | Experimental | Therapeutic Touch group Receives: Behavioral: Therapeutic touch |
| Control | No intervention | No therapeutic touch group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale - Comfort
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".
Measured: At the end of the third day
Hemodialysis Comfort Scale
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.
Measured: At the end of the third day
Perceived Stress Scale
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
Measured: At the end of the third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start31 Dec 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic TouchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061353
- Sponsor's protocol ID
- 2025/08-02
- Status last verified
- Nov 2025
- First submitted
- 2 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Touch on Perceived Stress and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07061353
- Acronym / sponsor ID
- 2025/08-02
- Conditions
- Therapeutic Touch, Hemodialysis Patients
- Keywords
- Therapeutic touch, Hemodialysis Patient, Stress, Comfort, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch | Experimental | Behavioral: Therapeutic touchTherapeutic Touch group |
| Control | No intervention | –No therapeutic touch group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 3 months of hemodialysis treatment • Cognitive function is in place
Key exclusion criteria (3 listed)
- Those with communication problems
- Those who do not agree to participate in the study
- Patients who receive traditional treatment for the disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic touchTherapeutic touch will be performed | Behavioural | Therapeutic Touch |
Primary outcome
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".
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eda Doğan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic touch in people with Therapeutic Touch and Hemodialysis Patients, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülcan Bahçecioğlu Turan (05065576086, glcnbah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale - Comfort (time frame: At the end of the third day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.