NCT05024201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

August 27, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

April 21, 2021

Last Update Submit

August 22, 2021

Conditions

Keywords

HemodialysisNursingLonelinessHopelessnessTherapeutic Touch

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Scales are filled after 3 days of application.

Study Arms (2)

experimental group for effect of therapeutic touch

EXPERIMENTAL

Therapeutic touch was applied to the experimental group for three days every other day.

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.

Interventions

Therapeutic touch was applied to hemodialysis patients for 3 days every other day.

experimental group for effect of therapeutic touch

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ZEHRA

Bayram, 80000, Turkey (Türkiye)

Location

Zehra Bayram

Osmaniye, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Touch

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Songül Karadağ

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

April 21, 2021

First Posted

August 27, 2021

Study Start

January 29, 2021

Primary Completion

May 29, 2021

Study Completion

June 29, 2021

Last Updated

August 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP, ICF
Time Frame
Data is continuously available after publication
Access Criteria
Data can be shared publicly
More information

Locations