LonelinessnursingNCT05024201
The Effect Of Therapeutic Touch On Loneliness and Hopelessness
A study testing THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS in people with Loneliness and Hope, run by Zehra Bayram at 2 sites in Turkey (Türkiye).
Trial summary
The effect of therapeutic touch applied to hemodialysis patients on the level of loneliness and hopelessness is being investigated. It encourages nurses to practice therapeutic touch. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Hope
- What is being tested?
- THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 29 Jan 2021to 29 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having hemodialysis treatment for at least 3 months,
- Cognitive patients,
- Having a score of UCLA> 20 and BECK≥4 scoring,
- Involved in the work with us.
Who cannot join
- Patients using traditional treatment for the disease were not included in the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effect Of Therapeutic Touch Applied to Hemodialysis Patient On The Level Of Loneliness And Hopelessness
The effect of therapeutic touch applied to hemodialysis patients on the level of loneliness and hopelessness is being investigated. It encourages nurses to practice therapeutic touch.
Read the detailed description
Chronic diseases are a challenging process that affects human life physiologically and psychologically. Chronic Renal Failure, which shows a significant increase in the world and in our country, also affects human life in every aspect. Hemodialysis treatment is used with a high rate in the treatment of patients diagnosed with End Stage Renal Failure.
Hemodialysis patients experience loneliness and hopelessness during their difficult and compulsory treatmet. Fear of being alone is an important problem affecting the patient's compliance with treatment. In addition, the other problem these patients experience is hopelessness. Hopelessness is an important factor that affects the patient's expectations for the future and the process of solving problems.
Therapeutic touch is a complementary and alternative treatment method. It is stated that this treatment method, which is successfully used by nurses, is good for loneliness and hopelessness. This method, which will be used on hemodialysis patients, is aimed to get away from the problems of loneliness and hopelessness.
In this study, two scales will be used to measure the loneliness and hopelessness levels of hemodialysis patients. Patients will fill in UCLA Loneliness Scale and BECK Hopelessness Scale.
Nurses should not ignore the problems of loneliness and hopelessness in hemodialysis patients. Therapeutic touch treatment method wil lprovide nurses the holistic caregiver role for the feelings of loneliness and hopelessness experienced by the patients. When the literature is scanned, this study is unique because it has not been done before on hemodialysis patients.
- Conditions
- Loneliness, Hope
- Being tested
- THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS
- Keywords
- Hemodialysis, Nursing, Loneliness, Hopelessness, Therapeutic Touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTSBehavioural
Therapeutic touch was applied to hemodialysis patients for 3 days every other day.
| Study group | Role | What they receive |
|---|---|---|
| experimental group for effect of therapeutic touch | Experimental | Therapeutic touch was applied to the experimental group for three days every other day. Receives: Behavioral: THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS |
| control group for effect of therapeutic touch | No intervention | No application was applied to the control group. Only pretest and posttest were done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of therapeutic touch on loneliness in hemodialysis patients
Developed by Russell et al. in 1980, the UCLA Loneliness Scale consists of 20 items, 10 of which are straight and 10 of which are reversed. Each item is scored between 1-4. While calculating the loneliness score, the calculation is made by taking the reverse of the scores given to the items used adversely. The highest score that can be obtained from the scale is 80, and the lowest score is 20. Higher scores indicate that individuals experience more loneliness.
Measured: Scales are filled after 3 days of application.
The effect of therapeutic touch on hopelessness in hemodialysis patients
The scale developed by Beck et al. in 1974 to measure hopelessness consists of 20 items and is scored between 0 and 1. The items in the scale are Emotions and Expectations about the Future (1, 3, 7, 11 and 18), Loss of Motivation (2, 4, 9, 12, 14, 16, 17 and 20), and Hope (5, 6, 8, 10, 13). , 15 and 19) have three sub-dimensions. The lowest score that can be obtained from the scale is 0, the highest score is 20, and a high score indicates a high level of hopelessness.
Measured: Scales are filled after 3 days of application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start29 Jan 2021
- Primary completion29 May 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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
- Model description
- In this study, two scales will be used to measure the loneliness and hopelessness levels of hemodialysis patients. Patients will fill in UCLA Loneliness Scale and BECK Hopelessness Scale.Therapeutic touch treatment method will provide nurses the holistic caregiver role for the feelings of loneliness and hopelessness experienced by the patients. When the literature is scanned, this study is unique because it has not been done before on hemodialysis patients.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zehra Bayram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zehra Bayram, Cukurova University
- Investigators
- Songül Karadağ, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024201
- Sponsor's protocol ID
- 10364632
- Acronym
- nursing
- Status last verified
- Jul 2021
- First submitted
- 21 Apr 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Therapeutic Touch Applied to Hemodialysis Patient On The Level Of Loneliness And Hopelessness
- ClinicalTrials.gov ID
- NCT05024201
- Acronym / sponsor ID
- nursing / 10364632
- Conditions
- Loneliness, Hope
- Keywords
- Hemodialysis, Nursing, Loneliness, Hopelessness, Therapeutic Touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zehra BayramUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 29 May 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 27 Aug 2021 (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.
The effect of therapeutic touch applied to hemodialysis patients on the level of loneliness and hopelessness is being investigated. It encourages nurses to practice therapeutic touch.
Detailed description
Chronic diseases are a challenging process that affects human life physiologically and psychologically. Chronic Renal Failure, which shows a significant increase in the world and in our country, also affects human life in every aspect. Hemodialysis treatment is used with a high rate in the treatment of patients diagnosed with End Stage Renal Failure.
Hemodialysis patients experience loneliness and hopelessness during their difficult and compulsory treatmet. Fear of being alone is an important problem affecting the patient's compliance with treatment. In addition, the other problem these patients experience is hopelessness. Hopelessness is an important factor that affects the patient's expectations for the future and the process of solving problems.
Therapeutic touch is a complementary and alternative treatment method. It is stated that this treatment method, which is successfully used by nurses, is good for loneliness and hopelessness. This method, which will be used on hemodialysis patients, is aimed to get away from the problems of loneliness and hopelessness.
In this study, two scales will be used to measure the loneliness and hopelessness levels of hemodialysis patients. Patients will fill in UCLA Loneliness Scale and BECK Hopelessness Scale.
Nurses should not ignore the problems of loneliness and hopelessness in hemodialysis patients. Therapeutic touch treatment method wil lprovide nurses the holistic caregiver role for the feelings of loneliness and hopelessness experienced by the patients. When the literature is scanned, this study is unique because it has not been done before on hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, two scales will be used to measure the loneliness and hopelessness levels of hemodialysis patients. Patients will fill in UCLA Loneliness Scale and BECK Hopelessness Scale.Therapeutic touch treatment method will provide nurses the holistic caregiver role for the feelings of loneliness and hopelessness experienced by the patients. When the literature is scanned, this study is unique because it has not been done before on hemodialysis patients.
| Arm | Type | Receives |
|---|---|---|
| experimental group for effect of therapeutic touch | Experimental | Behavioral: THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTSTherapeutic touch was applied to the experimental group for three days every other day. |
| control group for effect of therapeutic touch | No intervention | –No application was applied to the control group. Only pretest and posttest were done. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having hemodialysis treatment for at least 3 months,
- Cognitive patients,
- Having a score of UCLA> 20 and BECK≥4 scoring,
- Involved in the work with us.
Key exclusion criteria (1 listed)
- Patients using traditional treatment for the disease were not included in the study.
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 |
|---|---|---|
| THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTSTherapeutic touch was applied to hemodialysis patients for 3 days every other day. | Behavioural | experimental group for effect of therapeutic touch |
Primary outcome
The effect of therapeutic touch on loneliness in hemodialysis patients
Time frame: Scales are filled after 3 days of application.
Developed by Russell et al. in 1980, the UCLA Loneliness Scale consists of 20 items, 10 of which are straight and 10 of which are reversed. Each item is scored between 1-4. While calculating the loneliness score, the calculation is made by taking the reverse of the scores given to the items used adversely. The highest score that can be obtained from the scale is 80, and the lowest score is 20. Higher scores indicate that individuals experience more loneliness.
The effect of therapeutic touch on hopelessness in hemodialysis patients
Time frame: Scales are filled after 3 days of application.
The scale developed by Beck et al. in 1974 to measure hopelessness consists of 20 items and is scored between 0 and 1. The items in the scale are Emotions and Expectations about the Future (1, 3, 7, 11 and 18), Loss of Motivation (2, 4, 9, 12, 14, 16, 17 and 20), and Hope (5, 6, 8, 10, 13). , 15 and 19) have three sub-dimensions. The lowest score that can be obtained from the scale is 0, the highest score is 20, and a high score indicates a high level of hopelessness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Yes. Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form
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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. This study is not recruiting at the moment.
Songül Karadağ principal investigator
Cukurova University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS in people with Loneliness and Hope, run by Zehra Bayram at 2 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of therapeutic touch on loneliness in hemodialysis patients (time frame: Scales are filled after 3 days of application.). The study lists 2 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 27 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.