Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05568342 |
| Other study ID # |
Roy Adaptation Model |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2016 |
| Est. completion date |
July 10, 2017 |
Study information
| Verified date |
September 2022 |
| Source |
Gaziantep Islam Science and Technology University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
1. Introduction and Objective Chronic Renal Failure (CKD) is a chronic and progressive
deterioration in the functions of the kidney (Ammirati, 2020). Dialysis and renal
transplantation applications play an important role in the treatment of CKD (Zhang and
et al. 2020). However, dialysis is the most preferred treatment method because renal
transplantation is not suitable for every patient and the risk of rejection is high
(Imtiaz and Alam, 2021; Bleyer, 2022). Hemodialysis treatment is used in 70% of the
patients in the world (Bello and et al. 2022) and in 76.9% of the patients in Turkey
(Süleymanlar, 2020).
While hemodialysis treatment saves patients from death and enables them to continue
living, it also brings with it some physical, psychological, social and economic
problems (Aksoy and Oğur, 2015). Loss of physical strength and endurance, body image
disorder, fear of death, financial difficulties, diet, fluid intake, restricted
activities, being dependent on machinery and hospital at certain days and hours of the
week, invasive procedures applied in each session, loss of social relations, and
dependence on medical treatment cause this disease to be perceived as an extreme source
of stress, and changes caused by the disease in family and marital life increase the
severity of the stress (Topbaş & Bingöl, 2017).
The stress experienced negatively affects the psycho-social adaptation and self-care
power of patients (Varol & Sivrikaya, 2018). While patients' non-compliance with
treatment increases morbidity, mortality and economic problems (Sultan et al., 2022),
inadequacy in self-care power causes problems in controlling the disease process and
symptoms and meeting patients' own needs (Avanji et al., 2021; Gamze and Entertainment,
2013). Therefore, holistic nursing care has an important place in increasing the
psycho-social adjustment and self-care power of hemodialysis patients.
The use of models will guide nurses in providing standardization in holistic nursing
care (Jasemi et al., 2017). The Roy Adaptation Model (RAM), one of the models widely
used in nursing, creates a framework for determining the adaptation needs of
individuals, families and groups, and focuses on the changes that occur in the adaptive
system of the human and the environment. In this model, which includes four areas of
adaptation: physiological, self-concept, role function and interdependence, the human
being is defined as a biopsychosocial entity who is in constant interaction with his/her
environment and is affected by stimuli (Roy et al., 2009). Associating the Roy
Adaptation Model with patients undergoing hemodialysis treatment and providing training
in line with this model may yield correct results in terms of nursing practice (Vicdan &
Karabacak, 2014). In the literature, in the care of epilepsy (Erdoğan, 2021), cancer
(Pehlivan et al., 2022), Covid-19 (Çaylar and Terzi, 2021), bariatric surgery (Guven et
al., 2021) and many other diseases (Dağcan et al., 2021; Başayar et al., 2020; Yoldaş et
al., 2019; Ilkaz et al., 2018), the Roy adaptation model was used. As a result of these
studies, it was determined that patients' compliance with treatment increased and that
nursing interventions gave positive results.
In the literature, there are descriptive (Vicdan and Karabacak, 2014) and experimental
studies (Vicdan and Karabacak, 2016) and case reports (Özdemir, 2022) studies showing
the benefits of using the Roy adaptation model in hemodialysis patient education in
terms of adaptation to illness. However, there is no experimental study evaluating
stress, self-care power and psychosocial adaptation in hemodialysis patients by
performing interventions according to the Roy adaptation model. For this reason, this
study is important in terms of enabling patients to cope with stress and increasing
their self-care power by increasing the adaptation to illness with the nursing
interventions applied to the patients according to the Roy adaptation model.
Objective The research was carried out to determine the effect of the nursing
intervention given to patients according to the Roy Adaptation Model on patients'
stress, psychosocial adjustment and self-care power and to contribute to patients and
nursing interventions.
The hypotheses in the post-test of the Roy group, which was applied according to the Roy
adaptation model, are as follows:
H1: Stress level is lower than the clinical group. H2: Self-care power level is higher
than the clinical group. H3: Psychosocial adjustment level is higher than the clinical
group.
2. Materials and Methods Location of the Research The study was conducted between 1
September and 30 November in the hemodialysis unit of a university hospital and at
patients' homes.
2.1. Type of the Research The research was performed as a randomized controlled experimental
study. Population and Sample of the Research 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),
and those who came to the dialysis session on Tuesday-Thursday-Saturday were included in the
Clinical group (control) (40 patients). The criteria for inclusion in the study were as
follows: the absence of hearing and visual impairments that would prevent communication; no
diagnosed psychiatric disorder; literacy; and Turkish proficiency.
2.1. Data Collection Tools 2.1.1. Descriptive Characteristics Form This form, prepared by the
researchers, was created under the headings of socio-demographic characteristics (7
questions) and characteristics related to the disease (13 questions).
2.1.2. Hemodialysis Stressor Scale The scale developed by Baldree et al. (1982) was adapted
to Turkish society by Kara (2006). The perceived physiological (6 items) and psychosocial
stressors (23 items) associated with the treatment of hemodialysis patients are listed in the
scale. The 5-point Likert scale is coded as "Always" (5 points), "Often" (4 points),
"Sometimes" (3 points), "Rarely" (2 points), "Never" (1 points). The Physiological
Hemodialysis Stressor sub-dimension score is between 6-30 points, the Psychosocial
Hemodialysis Stressor sub-dimension score is between 23-115 points, and the total scale score
is between 29-145. An increase in the score obtained from the scale indicates an increase in
the perceived stress level. The total Cronbach alpha value of the scale is 0.77 (Kara,2006).
The Cronbach's alpha value of our study was 0.85 in the pre-test group and 0.80 in the
post-test group.
2.1.3. Self-Care Power Scale It is a scale developed by Ören (2010) for hemodialysis and
peritoneal dialysis patients. The scale is a 3-point Likert-type scale consisting of 22 items
and is scored between 0-2. The items 12, 22, 23, and 25 on the scale are reversed. Each item
is answered as 'I always apply' (2 points), 'I sometimes apply' (1 point) and 'I do not apply
at all' (0 points). The total score obtained from the scale is between 0-44. The scale has 5
sub-dimensions: Drug Use: 1,2,3,4,5,20, Diet: 8,9,10,11,12, Self-Monitoring: 6,7,13,14,
Hygienic Care: 16,17 ,18,21, and Mental State 22,23,25. Scoring for the sub-dimensions is
obtained by summing the item scores under each sub-dimension. At this point, drug use scores
change between 0-12, diet scores change between 0-10, self-monitoring scores change between
0-8, hygienic care scores change between 0-4, and mental state scores change between 0-6. Low
scores obtained as a result of the analysis indicate that self-care power is not good,
whereas high scores indicate good self-care power. The Cronbach's alpha value of the whole
scale was 0.75 in the hemodialysis group (Ören, 2014). The Cronbach's alpha value of our
study was 0.70 in the pre-test group and 0.73 in the post-test group.
2.1.4. Psychosocial Adjustment to Illness-Self-Report Scale This scale, which was developed
by Derogatis (1986) and evaluates psychosocial adjustment to illness, measures the
interaction of individuals with other individuals and institutions that make up the
socio-cultural environment. This scale, which was validated in Turkey by Adaylar (1995),
consists of 46 items and 7 sub-dimensions. These sub-dimensions are Healthcare orientation,
Vocational environment, Domestic environment, Sexual relationships, Extended Family
Relations, Social Environment and Psychological distress. Each item is scored between 0-3.
Major negative changes since illness are scored with 3 points, whereas no change or positive
changes are scored with 0 points. The total score obtained from the scale is between 0-138. A
low score on this scale indicates "good psychosocial adjustment" to illness, and a high score
indicates "poor psychosocial adjustment" to illness. The Cronbach's alpha value of the whole
scale was determined as 0.94 (Adaylar, 1995). The Cronbach's alpha value of our study was
0.91 in the pre-test group and 0.94 in the post-test group.
2.2. Data Collection Method 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.
2.3. Evaluation of Data The data were evaluated with the SPSS 23 package program. Percentage,
mean and standard deviation values were given for numerical variables, and frequency
distributions were given for categorical variables. Chi-square was used to determine the
relationship between categorical variables, the independent sample t-test was used to examine
the difference between two groups, and the paired-sample t-test was used to examine the
changes in the scale averages measured at two different times over time.
2.4. Ethical Principles Permission was obtained from the ethics committee of the University
to conduct the study. Consent was obtained from the patients who participated in our study,
which was conducted in accordance with the principles of the Declaration of Helsinki. In
addition, interventions were applied to the patients in the clinical group at the end of the
study, and a training booklet was given.
