Research Design: In
the current study; a pretest-posttest control group quasi-experimental design
Setting: The current study took
place in shock wave lithotripsy unit at Prince Mutaib
Bin Abelaziz Center Hospital.
sample of patients for this study included anyone who presented to the unit and
required first session of shock wave lithotripsy treatment. A convenience
sample consisted of 74 subjects meeting the study criteria. The patients were divided into study and
control group. The study group (37 patients) received the designed
instructions by the researcher before ESWL procedure, while the control group
(37patients) did not receive any instructions prior to ESWL procedure other
than the routine hospital instructions. Patients examined in this unit are on a
waiting list and are given an appointment for the examination.
The subjects had to
be 18 years of age or older (male and female), with upper urinary tract stone
(renal and upper ureter stones) undergoing first session of ESWL procedure.
Patients with previous
ESWL session, patients with anxiety disorders and mental disabilities who
aren’t able to understand the teaching module.
Tools: Four tools
were used to collect data for the study:
1. An interviewing questionnaire sheet: This questionnaire
was designed by the researchers and composed of two parts:
Part 1 Demographic and Medical Data: such as sex,
age, marital status, and level of education, type of the stone … etc.
2 knowledge assessment questionnaires: it
was designed by researchers after
the extensive literature. It
consist of 10 questions
assess patient’s knowledge about ESWL, contraindications, preparation, post -ESWL
complications, and post procedure management. The
scoring system for the questionnaire was as follows;
the correct complete answer was given the score of “2”, the correct
incomplete answer was given “1” and the wrong answer was given
the score of “zero”. Percentage
= Obtained score /
total score x 100. Based upon scoring system utilized the
knowledge levels were categorized as follows: poor < 60%, avarage from 60%-75% and good above 75%. 2- State–Trait Anxiety Inventory (STAI), (Spielberger, Gorsuch, and Lushene, 1983). STAI, is a self-reporting test, was used to assess state anxiety levels. It has demonstrated reliability and validity in previous studies. A valid and reliable English version of the scale was used. Total possible anxiety scores range from 20 to 80 , the scoring system is as a follow ; no anxiety (0 to 19), mild (20 to 39), moderate (40 to 59) and severe (60 to 80). 3. Horizontal visual analogue scale of 10 cm (0-100 mm) for assessment of claustrophobia the higher score indicates greater intensity of claustrophobia (Wewers & Lowe 1990). 4. Visual analogue scale of 10 cm (0-100 mm) cm which used to measure the degree o f pain the subject is experiencing. A higher score indicates greater pain degree. The scoring system is described as a follow; no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm). (Stratton Hill,, 1997). Reliability assessment: These tools have been tested and reviewed by the researcher, then by a panel of six medical and nursing experts for tools content validity, their opinions were elicited regarding to the tools format layout, consistency, scoring system. Reliability of all items of the Interview questionnaire Sheet was done using test – retest that revealed that, all items were significant and has a correlation coefficient above the significance level (r= 0 .75). Pilot study A pilot study was carried out before starting of data collection on (10%) of the sample to evaluate the tentative developed tools for clarity and applicability, as well to estimate the time needed for data collection. Needed modifications were carried out. Fieldwork: Data were collected over a period of about 7 months started from Saturday 10-2-1437h to the end of 8-1437 H. It was carried out in two phases: preparatory and implementation phase. Procedure: phases of the current study: I- Preparatory phase: This phase included formulation of the study tools and preparation of the pre-instructional module. The module was designed by the researchers to provide patients with information about ESWL meaning, machine description, contraindications, preparation, post -ESWL complications, and postoperative management after reviewing the extensive literature. II: Implementation phase: Administrative approvals for collecting data were obtained from the director of the hospital and the head of ESWL unit. The purpose of the study discussed to the director of the hospital and the head of ESWL unit as well, the nurse who is responsible for patient preparation of department to gain their cooperation. Method of data collection was explained and a list of patients' names with the schedule for patients' was obtained. Oral consents were taken from patients to participate in the study for each patient. At first interview, the researchers introduce themselves to initiate line of communication, explain the nature, purpose of the module. Each patient individually assessed for their level of knowledge, anxiety and claustrophobia before they began the intervention as well as before beginning the procedure of ESWL examination. Patients who could not read or write were helped by the researchers to fill out the sheet. English tool were translated into Arabic for Arabian. Patients were divided based on simple randomization into (37 control group and 37study group). The instructions designed by the researchers were given and explained to the study group as a manipulation of the independent variable; the dependent variables were the subjects' knowledge, anxiety and pain level in addition to claustrophobia intensity. Patients were recruited from the ESWL unit appointment book at Prince Mutaib Bin Abdel Aziz Central Hospital. (number 1 usually for study group and number 2 for control group, number 3 was for study group, number 4 was for control group…..etc). One to two patients were interviewed per each day based on patients' response and inclusion criteria. 30-45 minutes were spent with each patient for filling assessment sheet according to patient response. Three tools used three times for the same patients( knowledge questionnaire, anxiety scale, and claustrophobia intensity scale) except for pain scale used 4 times as the following; For the study group, Knowledge assessment questionnaire was tested three times; first time before giving instructions, after that the patients received instructions and booklet. Knowledge assessment questionnaire was tested for the second time before first session. It was tested for the third time before the second sessionFor the control group, Knowledge assessment questionnaire was tested three times; at the first interview before extracorporeal shock waves lithotripsy session, Immediately before the first session and before the second sessionFor the study group, patients were assessed for anxiety and claustrophobia intensity before giving the pre-instructional module, at the first session, and at the second session.For the control group; patients were assessed for anxiety and claustrophobia intensity in the first interview, at the first session and at second session. For pain assessment, both groups were assessed during and after first and second session. Pain was rated by the patients using a 10-point visual analog scale (VAS). Researcher interviewed patients of the study group through three educational sessions. The sessions were conducted by the researcher in a simple Arabic language using discussion, posters, and handout. Each patient obtained a copy of the pre-instructional module booklet included all educational content. Statistical analysis The percentage distribution, mean and standard deviation, chi-squared test and t-test used to ascertain any significant differences between the study and control groups. The level of significance taken when P ? 0.05