NCT05568342

Brief Summary

Abstract Objective: The research was conducted to determine the effect of the nursing intervention, which was given to patients according to the Roy Adaptation Model, on patients' stress, psychosocial adjustment, and self-care power. Methods: The population of the study, which was conducted as a randomized controlled experimental study, consisted of 80 patients receiving outpatient dialysis treatment in the hemodialysis unit of a university hospital. The patients from the population were included in the sample of the study in a randomized manner. The data were collected using the Descriptive Characteristics Form, the Hemodialysis Stressor Scale, the Self-Care Scale, and the Psychosocial Adjustment to Illness Scale. Results: When the pre-tests between the groups were compared, hygienic self-care power, healthcare orientation, vocational environment, domestic environment, sexual relationships, extended family relations, social environment and total psychosocial adjustment levels changed significantly (p\<0.05). When the post-tests were compared between the groups, no significant difference was found only in the mean of the mental state sub-dimension (p\>0.05). Conclusion: Interventions made according to the Roy Adaptation Model reduced the stress level of the patients, and increased their self-care power and psychosocial adjustment. Keywords: Hemodialysis, Roy Adaptation Model, Stress, Self-Care Power, Psychosocial Adjustment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

October 5, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 28, 2022

Last Update Submit

September 30, 2022

Conditions

Keywords

Hemodialysis, Roy Adaptation Model, Stress, Self-Care Power, Psychosocial Adjustment

Outcome Measures

Primary Outcomes (1)

  • Stress

    Stress was evaluated with the Hemodialysis Stressor Scale

    It was used to determine stress levels before starting the study. After 3 months, the interventions were finished and it was used again to measure stress levels.

Secondary Outcomes (1)

  • Psychosocial Adjustment

    It was used to determine compliance levels before starting the study. After 3 months, the interventions were finished and again used to measure compliance levels.

Other Outcomes (1)

  • Self-Care Power

    It was used to determine self-care levels before starting the study. After 3 months, the interventions were finished and it was used again to measure self-care levels.

Study Arms (2)

Roy Group

EXPERIMENTAL

The population of the research consisted of 80 patients receiving outpatient dialysis treatment in the hemodialysis unit of a university hospital. In the sample of the study, those patients who came to the dialysis session on Monday-Wednesday-Friday were randomly assigned to the Roy group (experimental) (40 patients). Pre-test was applied to the patients in Roy and clinical groups using data collection tools. After the pre-test, the patients in the Roy group were trained 6 times in 3 months, twice a month, at home and in the clinic. Nursing interventions were performed using the Roy Adaptation Model in the trainings. At the end of the third month, the post-test data of both groups were collected. During the study, no training or intervention was given to the patients in the clinical group. The nursing education and interventions of this group were carried out by nurses working in the dialysis clinic within the scope of routine practices.

Behavioral: The Effect of Roy Adaptation-Based Nursing Intervention on Stress, Psychosocial Adjustment and Self-Care Power in Hemodialysis Patients: A Randomized Controlled Experimental Study

Clinic Group

NO INTERVENTION

The population of the research consisted of 80 patients receiving outpatient dialysis treatment in the hemodialysis unit of a university hospital. In the sample of the study, those patients who came to the dialysis session on Tuesday-Thursday-Saturday were included in the Clinical group (control) (40 patients). Pre-test was applied to the patients in Roy and clinical groups using data collection tools. After the pre-test, the patients in the Roy group were trained 6 times in 3 months, twice a month, at home and in the clinic. Nursing interventions were performed using the Roy Adaptation Model in the trainings. At the end of the third month, the post-test data of both groups were collected. During the study, no training or intervention was given to the patients in the clinical group. The nursing education and interventions of this group were carried out by nurses working in the dialysis clinic within the scope of routine practices.

Interventions

Pre-test was applied to the patients in Roy and clinical groups using data collection tools. After the pre-test, the patients in the Roy group were trained 6 times in 3 months, twice a month, at home and in the clinic. Nursing interventions were performed using the Roy Adaptation Model in the trainings. At the end of the third month, the post-test data of both groups were collected. During the study, no training or intervention was given to the patients in the clinical group. The nursing education and interventions of this group were carried out by nurses working in the dialysis clinic within the scope of routine practices.

Roy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the absence of hearing and visual impairments that would prevent communication
  • no diagnosed psychiatric disorder
  • literacy
  • Turkish proficiency

You may not qualify if:

  • Not wanting to voluntarily participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Şahinbey Research and Application Hospital Hemodialysis Unit

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Zeynep GÜNGÖRMÜŞ, phD (Associate Professor)

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 5, 2022

Study Start

September 1, 2016

Primary Completion

November 30, 2016

Study Completion

July 10, 2017

Last Updated

October 5, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations