This study is a randomized controlled clinical trial was implemented with 213 patients in three groups at Javad-Al-Aemeh Hospital, Mashhad, Iran, during February to September 2018. The patients were randomly allocated to three groups, film (n = 73) (providing an evidence based educational guidance through film), group discussion (n= 71) (providing an evidence based educational guidance with group discussion) and control (n= 69) (providing routine education). Because the method of the research was based on educating, the patients in all three group knew they are allocated in which group. Also the first researcher was the man who guided the discussion groups and set the time of showing film to the videotape group, then he couldn't be blind in this study. Only the analyzer of the data was blind about the sampling.
According to a guide study (8) along with a comparison mean scores formula considering 95% confidence interval and 80% test power were used and estimated 44 individuals in each group as the sample size. Considering the probability of loss and the difference between two angiography and angioplasty procedures, and also the arterial access way (radial or femoral) the study population increased to 70 patients per group.
Inclusion criteria included: Age between 30 -70; ability to speak and communicate; literacy; no previous history of cardiac catheterization; no kidney ( eGFR(Estimated glomerular filtration rate ) <30 ml/ min), heart (LVEF(Left Ventricular Ejection Fraction ) <40% ) and liver failure; no history of mental diseases (using psychiatric drugs) or severe stressors (divorce or death of closed relatives) in the past six months. Exclusion criteria included: life-threatening heart rhythm (ventricular fibrillation, pulse-free ventricular tachycardia), need for CPR, systolic blood pressure less than 90mmHg, embedded balloon pump, and more than once attempt at arterial access (multi-puncture).
The statistical population consisted of patients undergoing coronary angiography and angioplasty in Javad Al-Aemeh Cardiology Hospital of Mashhad (Iran). Participants were patients of both sexes who were candidates for angiography or angioplasty from February to September 2018.
225 patients with the inclusion criteria were selected and then assigned to one of three groups, namely film screening (n= 76), group discussion (n= 74) and control (n= 75) by the time block random method. Only one form of intervention was necessarily implemented every day in order to prevent the association of groups and transfer of information to each other. Therefore, the number of days of month (30) were first given to www.Randomization.com. The first 10 digits were randomly assigned to videotape group, the second 10 to the control group, and the third 10 to the discussion group. Based on the sampling date, patients were assigned to a group based on the random digits of that day, and then the appropriate method was taken.
For example at the beginning of the research the researcher assessed the date it was 4th of February 2018, then according to the random digits, number 4 was allocated to the videotape group. Then all of the patients admitted for doing angioplasty or angiography in 4th of February were assessed according to the inclusion and exclusion criteria. Then the patients who had the inclusion criteria completed the informed consent and then the rest of the research questionnaires. Then the film was showed to them with the television of their room.
The process continued until sampling was completed. During the study, 6 individuals in the control group, 3 in the discussion group, and 3 in the film screening group were excluded. The final analysis was performed on 213 patients (Figure 1).
Thus although the number of samples in each group were determined 70, in the last day of sampling in two groups the numbers of patients got more. Because the process of sampling was time block and the researcher selected all of the eligible patients to the educational program in the target day.
The method of this research was included in to two steps: 1- an integrative review 2- a randomized clinical trail
1- At the first an integrative review was done to prepare an organized educational package. All of the original and guideline articles in Pubmed, Google Scholar, clinical key, Eric and SID were searched from October 2010 to October 2018. The key words were Anxiety, contrast- induced Nephropathy, Coronary Catheterization, Patient education, Nursing care were used by the linkage of AND, OR. After revising 17 articles were included in to the integrative review. Then the recommendations for prevention of anxiety contrast- induced nephropathy and in cardiac catheterization were extracted from the literature.
The main subjects of patient education were categorized in two titles 1- prevention of contrast induced nephropathy 2- prevention of anxiety 3- prevention
According to the articles the recommendations were ordered for three groups 1- Heart specialists 2- Nurses(17) 3- Patients
The main categories of prevention of contrast induced nephropathy were fluid therapy (23, 24) (intravenous and oral intake)(25, 26), caution to order and use drugs(27) and monitoring the serum creatinine and GFR(28).The main categories of prevention anxiety were included informing and educating the patients about the hospitalization(16, 19), the procedure of coronary catheterization(29), the complications and limitations, and the hospital environment(18).
2- After preparing the organized educational content, a scenario was provided in a simple language. To produce a film, the researcher contracted with a professional film maker team. The film was made in the actual hospital environment. The benefits of this 30-minute film were the use of real-time contexts, spoken and written explanation, special effects, music, standard animation as well as the use of professional, experienced team of directing, filming, sound recording and editing.
3- The third step was the clinical trial that was conducted in three groups. So that patients' demographic and disease data along with blood pressure, and pulse rates were first measured. Thereafter, the pre-procedure blood samples from patients were taken. Then, Spiel Berger state-trait anxiety inventory was given to patients prior to the intervention.
In group discussion, groups of 4 to 6 patients with a circular-shaped arrangement with researcher were created in the education class of the angiography ward. The researcher stated the purpose of group creation; and the patients introduced themselves to the group. The educational content (based on the organized educational guidance) was then provided for 15 minutes, followed by discussion by the team members by asking purposive questions led by the researcher. Finally, the researcher made sure that all members understood the content correctly. The group discussion lasted for approximately 30 minutes.
In the film screening group, the film (based on the instructional guideline) was displayed in the patient room television for 30 minutes.
The instructional pamphlets and routine hospital care were provided in the control group. After the intervention and an hour before transferring patients to the Cath Lab, the Spiel Berger state anxiety inventory was again completed by the patients.
Serum creatinine was measured 24 hours after the procedure at the hospital to evaluate the incidence of contrast-induced nephropathy. The discharged patients were referred to the laboratory of Javad Al-Aemeh Cardiology Hospital for a third time serum creatinine testing 72 hours after.
The instruments included the demographic and disease information questionnaire and the Spiel Berger Anxiety Inventory, including the state (situational) and trait anxiety.
The demographic and disease information questionnaire was constructed by the researchers according to the literature review. The content validity of the questionnaire was confirmed by 10 members of the special cardiac catheterization nurses and physicians.
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety that was introduced by Spiel Berger and his colleagues at 1983 (30). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes (31, 32).
Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”). Higher scores indicate greater anxiety.
Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (30). Test-retest coefficients for this measure ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (33).
Its Persian translation validity has been confirmed in a master thesis in Allameh Tabatabaee university of Tehran By Mahram in1994(34).
Its reliability was confirmed by Cronbach's alpha method with a value of 0.86 in this study.
The creatinine was measured by the laboratory of Javad Al-Aemeh Cardiology Hospital by HITACHI 717 apparatus through blood sampling. Its reliability was determined by the internal calibration method. The research data was statistically analyzed by SPSS 15. The significant level was considered by P<0.05. The data were at first tested about the normality by Kolmogorov–Smirnov test. The data were analyzed by chi square, one way ANOVA and Tukey HSD post hoc, repeated Measure ANOVA and paired t test.
The present study was conducted according to the ethical criteria of the Helsinki statement and was approved by the Ethics Committee of Mashhad University of Medical Sciences with a Code of Ethics (IR.MUMS.REC.1396.66). Participants were informed of study nature and their written consent to participate in the study was obtained. If the patient didn't want to continue the educational sessions he/she could leave the research any time.