The Effect Of Therapeutic Touch On Loneliness and Hopelessness (nursing)

August 22, 2021 updated by: Zehra Bayram

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bayram, Turkey, 80000
        • ZEHRA
      • Osmaniye, Turkey
        • Zehra Bayram

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Patients using traditional treatment for the disease were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group for effect of therapeutic touch
Therapeutic touch was applied to the experimental group for three days every other day.
Behavioral: THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS
Therapeutic touch was applied to hemodialysis patients for 3 days every other day.
No Intervention: control group for effect of therapeutic touch
No application was applied to the control group. Only pretest and posttest were done.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Scales are filled after 3 days of application.
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.
Scales are filled after 3 days of application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zehra Bayram

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Songül Karadağ, Çukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10364632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form

IPD Sharing Time Frame

Data is continuously available after publication

IPD Sharing Access Criteria

Data can be shared publicly

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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