Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial
Phase: NA
Conditions: Renal Disease, Adherence, Treatment, Quality of Life, Satisfaction, Patient
Sponsor: Akdeniz University

November 06, 2017 
 
 
 
 
Effect of Motivational Interviewing and Education Based on Watson’s Theory of 
Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial 
NCT Number: NCT04174638 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Principal Investigator 
 
Şefika Tuğba YANGÖZ, MSc 
Research Assistant 
Department of Internal Medicine Nursing, 
Faculty of Nursing, University of Akdeniz, 
Antalya/Turkey 
 
Study Director 
Zeynep ÖZER, PhD 
Professor 
Department of Internal Medicine Nursing, 
Faculty of Nursing, University of Akdeniz, 
Antalya/Turkey 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. INTRODUCTION 
Hemodialysis is the most common treatment in the end stage renal disease. In the 2018 report 
of the World Health Organization, it was stated that 2.62 million people received dialysis 
treatment in 2010 and 1.2 million people died from kidney disease in 2015 (Luyckx, Tonelli, 
& Stanifer, 2018). Hemodialysis consists of a complex process and adherence to treatment is 
very important for individuals receiving hemodialysis treatment. Adherence to fluid intake, 
diet and drug management is indicators of adherence to treatment (Naalweh et al., 2017; 
Tohme et al., 2017). Non-adherence to treatment leads to increased complications, decreased 
quality of life (QOL) and increased morbidity and mortality (Naseri-Salahshour, Sajadi, 
Nikbakht-Nasrabadi, Davodabady, & Fournier, 2020). Therefore improving adherence to 
treatment is important in hemodialysis. 
Motivational interviewing and education are frequently used to improve adherence to 
treatment and to develop healthy behavior in individuals receiving hemodialysis treatment 
(Crown, Vogel, & Hurlock-Chorostecki, 2017; Tao, Tao, Wang, & Bi, 2020). Since creating 
behavioral change is a complex process, it is recommended that the intervention be 
implemented systematically. Models or theories are important in guiding the interventions and 
their systematic application (Fawcett, 2005). One of these theories, Jean Watson’s Theory of 
Human Caring dwell on nursing care to be humanistic, conscious, purposeful and careful 
(Watson, 2018). It is thought that performing of motivational interviewing and education 
based on Watson’s Theory of Human Caring to individuals receiving hemodialysis treatment 
will contribute to improving adherence to treatment, patient satisfaction and QOL.  
This statistical analysis plan (SAP) will give more detailed descriptions of the endpoints in the 
study and the corresponding analyses. 
2. STUDY DESİGN 
2.1 Objective and Hypothesis 
The aims of the study were to evaluate the effectiveness of Motivational interviewing and 
education based on Watson’s Theory Of Human Caring on adherence to treatment, 
satisfaction and QOL in individuals receiving hemodialysis treatment. We hypothesized that 
intervention group who received Motivational interviewing and education based on Watson’s 
Theory of Human Caring would increase (a) adherence to fluid intake, (b) adherence to diet, 
(c) adherence to drug management, (d) QOL compared to the control group and (e) 

intervention group who receiving motivational interviewing and education based on Watson’s 
Theory of Human Caring would satisfied with introduced intervention. 
2.2. Design / Methodology 
A randomized controlled trial. 
2.3. Sample Size Calculation 
In this study, the sample size was calculated based on the “The Scale for Dietary Behaviors in 
Hemodialysis Patients” used in a similar study (Düzalan & Pakyüz, 2018). A total of 70 
individuals receiving hemodialysis treatment, 35 patients in each group, were included in the 
study based on a common type-I error rate of 0.05, the effect size rate of 0.80 and estimated 
loss to follow-up of 10%.  
2.4. Inclusion and Exclusion Criteria  
Inclusion criteria of the study were as follows:  
 participants were individuals aged ≥ 18 years,  
 received hemodialysis for at least 3 months,  
 had 1 and over from Diet and Fluid Non-Adherence Questionnaire (DDFQ) total 
score,  
 had 0 or 1 score from 1., 2. and 6. questions or 3., 4. and 5. questions in the Modified 
Morisky Scale (MMS),  
 willing to participate,  
 participants without language or communication barriers. 
The exclusion criteria of the study were as follows: 
 The participants diagnosed with psychiatric illness or malignancy were excluded from 
the study.  
2.5. Randomization and blinding 
The simple randomizaton method will used. Individuals receiving hemodialysis who met the 
inclusion criteria, agreed to participate in the study and signed the informed consent form 
were divided into either a intervention group or control group by coded randomization by 
researcher. An independent, blind statistician who will not involved in the research process 

prepared the random number table with SAS package 9.4. It will not possible allocation 
concealment as the intervention was performed by the researcher who received motivational 
interviewing and education. The researcher will not participate in the data analysis, the 
analyzes will made by an expert statistician. 
2.6 The Intervention   
The intervention group will received 15 minute motivational interviewing in four session once 
a month and one session face-to-face education with booklet at the first motivational 
interviewing based on Watson’s Theory of Human Caring before the hemodialysis session in 
a separate room in the hemodialysis unit. 
Motivational Interviewing: The semi-structured interview based on Watson’s Theory of 
Human Caring according to the principles of motivational interviewing such as open-ended 
questions, affirmation, reflection, summaries and speaking change will perform.  In the 
motivational interviewing sessions, the agenda will set for the individuals to talk about their 
current concerns about fluid intake, diet and drug management, and physical, psychological 
and social support problems. It will aimed to reveal the individuals’ personel goals to improve 
their adherence to treatment and the obstacles they perceived to achieve these goals. By 
working with the ambivalence of the individuals, supporting their optimism and self-efficacy 
and positive changes, individuals will enable to determine their own solutions. In addition, 
individuals will support for the maintaining of behavior change. 
Education: The education will apply face-to-face in one session for 30 minutes in the first 
motivational interviewing and an education booklet will give to the participants. The 
education booklet has been prepared by the researcher, according to evidence-based 
guidelines, literature search and result of study (https://rb.gy/nxkgf4, Accessed date: 
24.11.2017; https://rb.gy/totnpp, Accessed date: 27.11.2017). The education booklet was 
evaluated by 10 experts in the field of nephrology and hemodialysis according to Discern 
guide. The educational booklet includes sections on kidneys, kidney functions, causes, 
symptoms, stages and treatment of chronic kidney disease (CKD), nutrition in hemodialysis, 
fluid intake, drugs, hemodialysis related problems, laboratory parameters. 
Conceptual–theoretical–empirical (C-T-E) system-based nursing practice was used in the 
study. The C-T-E structure provide a purposeful and systematic process for nursing practice 
(Fawcett, 2005).  

2.7 Control Group  
The control group will receive routine hemodialysis treatment and nursing care in the 
hemodialysis unit. Routine nursing care consisted of dietary recommendations for high 
laboratory parameters and recommendations for patients' needs. The control group will 
receive face-to-face education for 30 minutes and education booklet at the 12th week.  
2.6. Outcomes 
This section will present the outcomes investigated to answer the study aims and objectives. 
The analyses are described in section 3 Analyses. 
 Adherence to fluid intake: it will be measured at baseline and 12th week using Fluid 
Control in Hemodialysis Patients Scale. 
 Adherence to diet: it will be measured at baseline and 12th week using The Scale for 
Dietary Behaviors in Hemodialysis Patients. 
 Adherence to drug management: it will be measured at baseline and 12th week using 
Modified Morisky Scale.   
 Patient satisfaction: it will be measured at 12th week in the intervention group using 
Watson Caritas Patient Score and Motivational Interviewing Evaluation Form.  
 Quality of life: it will be measured at baseline and 12th week using Kidney Disease 
Quality of Life-36 Scale.  
 Physical parameter: it will be measured at baseline and 12th week. 
Physical Parameters 
 Blood Pressure 
 BMI 
 Glucose mg/dL 
 BUN mg/dL 
 Creatinine mg/dL 
 Albumin g/dL 
 Potassium mEq/L 

 Phosphorus mEq/L 
 Hematocrit % 
 Hemoglobin g/dL 
 Total Protein mg/dL 
 Sodium mEq/L 
 Calcium mEq/L 
3. ANALYSIS 
The data were analysed with the IBM Statistical Package for Social Science (SPSS) for 
Windows version 25 (IBM, 2017). The normality test was performed with the graphical 
assessment, skewness and kurtosis test. Descriptive statistics for normally distributed 
numerical variables were presented as mean, standard deviations, n (%) or minimum-
maximum. While evaluating statistical significance, it was considered according to the p 
value of <0.05. 
Adherence to fluid intake, diet and drug management, physical parameters and quality of life 
will compare intervention groups (motivational interviewing and education based Watson’s 
Theory of Human Caring vs control treatment) on their mean change between baseline and 12 
weeks using independent sample t-test. In addition, effect size will evaluated by calculator for 
student’s t-test using G-Power programme. To identify the relationship of the change 
adherence to fluid intake, diet and drug management, physical parameters and quality of life 
with other variables such as group and demographic variables will use multivariate linear 
regression. 
Patiens satisfaction will analyzed using descriptive analysis such as n (%) or minimum-
maximum. 
 
 
 
 
 
 

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