Materialand Methods:Research Design: Inthe current study; a pretest-posttest control group quasi-experimental designwas used.Setting: The current study tookplace in shock wave lithotripsy unit at Prince MutaibBin Abelaziz Center Hospital. Sample: Thesample of patients for this study included anyone who presented to the unit andrequired first session of shock wave lithotripsy treatment. A conveniencesample consisted of 74 subjects meeting the study criteria.

The patients were divided into study andcontrol group. The study group (37 patients) received the designedinstructions by the researcher before ESWL procedure, while the control group(37patients) did not receive any instructions prior to ESWL procedure otherthan the routine hospital instructions. Patients examined in this unit are on awaiting list and are given an appointment for the examination.  Inclusion criteria:The subjects had tobe 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. Exclusion criteria:  Patients with previousESWL session, patients with anxiety disorders and mental disabilities whoaren’t able to understand the teaching module. Tools: Four toolswere used to collect data for the study: 1.  An interviewing questionnaire sheet: This questionnairewas 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. Part 2 knowledge assessment questionnaires: it was designed by researchers after reviewing the extensive literature.

It consist of  10 questions to 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–TraitAnxiety Inventory (STAI), (Spielberger, Gorsuch, and Lushene, 1983). STAI,is a self-reporting test, was used to assess state anxiety levels. It hasdemonstrated reliability and validity in previous studies.

A valid and reliableEnglish version of the scale was used. Total possible anxiety scores range from20 to 80 , the scoring system is as a follow ; no anxiety (0 to 19), mild (20to 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 intensityof claustrophobia (Wewers & Lowe 1990).  4.

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Visual analogue scale of10 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 describedas 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).

Reliabilityassessment:These tools have been tested andreviewed by the researcher, then by a panel of six medical and nursing expertsfor tools content validity, their opinions were elicited regarding to the toolsformat layout, consistency, scoring system. Reliability of all items ofthe  Interview questionnaire Sheet wasdone using test – retest that revealed that, all items were significant and hasa correlation coefficient above the significance level (r= 0 .75).  Pilot study  A pilot study was carried out before startingof data collection on (10%) of the sample to evaluate the tentative developedtools for clarity and applicability, as well to estimate the time needed fordata collection.

Needed modifications were carried out.Fieldwork: Data were collected over a period of about 7months started from Saturday 10-2-1437h to the end of 8-1437 H. It was carriedout in two phases:  preparatory and implementationphase.

 Procedure: phases of the currentstudy: I- Preparatory phase: Thisphase included formulation of the study tools and preparation of the pre-instructionalmodule. The module was designed by the researchers to provide patients withinformation 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 wereobtained from the director of the hospital and the head of ESWL unit. Thepurpose of the study discussed to the director of the hospital and the head of ESWLunit as well, the nurse who is responsible for patient preparation ofdepartment to gain their cooperation. Method of data collection was explainedand a list of patients’ names with the schedule for patients’ was obtained. Oral consents were takenfrom patients to participate in the studyfor each patient.

At first interview, the researchersintroduce themselves to initiate line of communication, explain the nature,purpose of the module. Each patient individually assessed for their level ofknowledge, anxiety and claustrophobia before they began the intervention aswell as before beginning the procedure of ESWL examination.Patients who could not read or write were helped by the researchers to fill outthe 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 wereinterviewed per each day based on patients’ response and inclusion criteria.

30-45minutes were spent with each patient for filling assessment sheet according topatient 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, Knowledgeassessment questionnaire was tested three times; first time before givinginstructions, after that the patients received instructions and booklet. Knowledgeassessment questionnaire was tested for the second time before first session.It was tested for the third time before the second sessionFor the control group, Knowledgeassessment questionnaire was tested three times; at the firstinterview before extracorporeal shock waves lithotripsy session, Immediatelybefore the first session and before the second sessionFor the study group, patients wereassessed for anxiety and claustrophobia intensity before giving thepre-instructional module, at the first session, and at the second session.For the control group; patients wereassessed for anxiety and claustrophobia intensity in the first interview, atthe first session and at second session. For pain assessment, both groups were assessed during andafter first and second session.  Pain wasrated 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 analysisThe percentage distribution, mean and standarddeviation, chi-squared test and t-test used to ascertain any significantdifferences between the study and control groups. The level of significance takenwhen P ? 0.05