INTRODUCTION

Background of the Study

As the technologic complexity of radiologic procedures has grown, the emotional reactions of patients to imaging procedures have become more prominent, and interaction between patients and the staff of diagnostic radiology units has become more important

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Like the smaller number of patients surveyed by Monics et al

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after undergoing a variety of radiologic procedures at a teaching hospital, patients in this sample were more concerned with explanations of procedures and results, and with factors affecting their physical comfort, than with the competency of the staff or their own convenience.

Patients awaiting therapeutic procedures commonly report anxiety

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, fears about the unknown, pain, possibility of further interventions, complications, destruction of body image, disruption of life plans, loss of control, disability, and loss of life

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Most of the time, one might assume that diagnostic tests, which typically carry fewer risks than invasive therapeutic procedures, would create less distress. Diagnostic tests, however, inherently harbor uncertainty, which can be a potent stressor and has been linked to poor coping with health-related issues, as well as poor adaptation and recovery

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Hence, the conduct of this study in this aspect will assess the level of distress in patients awaiting radiological procedure particularly in breast , transvaginal and scrotal ultrasound. The study will also provide effective protocol in the conduct of giving information to patients.

Review of Related Literature

Waiting room distress can impact patients and radiology resources by taxing “departmental resources in terms of appointment cancellations, patients’ lack of cooperation, extended room times, increased medication use, prolonged recovery and inability to complete imaging procedures well or at all, with adverse impact on both image quality and reimbursement,” wrote Nicole Flory, PhD, of the department of radiology at Beth Israel Deaconess Medical-Harvard Medical School in Boston, and colleagues

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Attention to patient’s acute distress before and during procedures is important because distress may cause hemodynamic instability, procedural complications, and other adverse events

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. As mentioned by KrantzDS et al

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, stress and anxiety may cause adverse events through elevated levels of blood pressure, heart rate, coronary constriction, and stress hormones.

Jangland et al

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found that, among those patients who complained about care and increased anxiety, the most common complaints were insufficient information, inadequate respect, and insufficient empathy.

In the study of Nicole Flory, et al

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they concluded that uncertainty of diagnosis can weigh heavily on the patient, and perceptions of what medical personnel may consider “minor” do not necessarily reflect the patient’s experience.

Training medical personnel in how to communicate with these patients and to assuage their distress promises not only to relieve the patients’ distress but also to positively affect departmental resources.

In our literature search, we identified no previous studies of topics related to anxiety reduction prior to radiologic procedure. Also, no particular studies were taken in comparative assessment of psychological distress in conjunction with imaging procedures using the standard verbal explanation against the audio visual presentation. This study therefore will take advantage of the availability of preprocedural surveys from prospective randomize control trials that will be performed in department of radiology with patients at various radiologic procedures using Hospital Anxiety and Depression Scale (HADS).

Research questions

1. What is the prevalence of anxiety and depression among patients referred for breast, transvaginal and scrotal ultrasound using the adaptive verbal pre-procedural briefing versus with complimentary audio visual presentation?
2. What is the level of anxiety and depression among patients referred for breast, transvaginal and scrotal ultrasound using the adaptive verbal pre-procedural briefing versus with additional audio visual presentation?
3. Is there any differences between anxiety and depression rate in patients undergoing breast, transvaginal and scrotal ultrasound using the adaptive verbal pre-procedural briefing versus with audio visual presentation?

Significance of the study

In the current set-up of our department in radiology, at most three residents are assigned to ultrasound section, catering 60 patients per day with resident to patient ratio of 1:30 in an 8 hour-shift. This would only give the resident 8 minutes per patient to do his/her doctor-patient interaction. All patients under fasting, are the most priority causing all other patient to have a waiting time of about an hour or two for her/him to be served, and this where the patients for breast, scrotal and transvaginal falls. These procedures also give more anxiety and distress if not explained well by their respective doctors because of its very intimate approach.

With this existing reality, having an audio-visual presentation as an additional tool of information might help alleviate patient’s anxiety and distress. This assessment is a first step in evaluating the adaptive verbal pre-procedural protocol in the radiology department with that of another additional audio-visual presentation, and the results of such an evaluation then can help guide specific interventions toward better outcomes.

Objectives

General objective

This study aims to compare the effectiveness of the additional audio-visual briefing presentation versus the adapted pre-procedural verbal briefing only among patients referred for breast, transvaginal and scrotal ultrasound in Department of Radiological and Imaging Sciences at Southern Philippines Medical Center, Davao City in reducing the level of anxiety/depression using Hospital Anxiety and Depression Scale (HADS) model.

Specifically, this study aims to determine the following:

a. Demographic and clinical profile of patients who will underwent breast, scrotal, transvaginal ultrasound.

b. To compare the effectiveness of adapted verbal pre-procedural briefing against with additional audio-visual presentation in decreasing the anxiety/depression level among patients referred for imaging study.

c. To suggest recommendation to policy makers and professionals for adoption of creative ways to control or minimize this phenomena.

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MATERIALS AND METHODS

Study Setting:

The study will be conducted at the Department of Radiological and Imaging Sciences waiting section at Southern Philippines Medical Center, Davao City. The study will be done over a period of three months (April to June 2014)

Study Participants

All patients referred to the Department of Radiology and Imaging Sciences facility at Southern Philippines Medical Center for breast, transvaginal and scrotal ultrasound, that is qualified to join in the study. Below are the inclusion and the exclusion criteria for patients who are candidates for the study.

Inclusion criteria

• Adult patients (18 – 65 years old) who will give their consent for the study.
• Understands English language
• Patients who do not meet any criteria for a mental health disorder using the Global Mental Health Assessment Tool (GMHAT) of the World Health Organization
• Patient should have mild or moderate levels of anxiety at the start of the trial
• Ambulatory
• Conscious

Exclusion criteria

All patients who will undergo breast, transvaginal and scrotal procedure that will not give their consent for the study and will not meet the inclusion criteria.

Baseline Data Collection

Consents for the research study will be obtained by the researcher between the ages of approximately 18 and 65 years of age.

All consecutive patients who had completed their consent from April to July 2014 will be evaluated for study eligibility by the researcher. All patients who will participate will undergo Global Mental Health Assessment Tool (GMHAT) of the World Health Organization to exclude patients having overt mental disorder and will be advised to seek professional help. A randomized selection of patients will be done wherein they are asked to blindly select which group they will fall by drawing lots. First group will undergo the usual verbal pre-procedural briefing while the second group will receive the additional audio-visual presentation. The researcher will ask consecutive eligible patients to participate in a study in which the level of anxiety and depression will be assessed prior to ultrasound procedure. Both groups will be handed identical stacks of psychological questionnaire: the Hospital Anxiety and Depression Scale(Appendix 1) under the supervision of the investigator. Patients will be at liberty with regard to the sequence in which they would fill out the questionnaires. Another identical stack of HADS questionnaires will be given to the participants after the end of the intervention still under the supervision of the investigator.

Outcome Measures

Socio-demographic questionnaires

The demographic information includes age, gender, education and occupation.

Hospital Anxiety and Depression Scale


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HADS):

The HADS is a screening tool for anxiety and depression in non-psychiatric clinical populations. The scale consists of 14 items (7 each for anxiety and depression). Each item is rated on a four point scale ranging from 0 (not at all) to 3 (very often). Responses are based on the relative frequency of symptoms over the preceding week. Possible scores range from 0 to 21 for each subscale. An analysis of scores on the two subscales supported the differentiation of each mood state into four ranges: ‘mild cases’ (scores 8-10), ‘moderate cases’ (scores 11-15), and ‘severe cases’ (scores 16 or higher).

HADS was validated by group of researchers (Ingvar Bjelland, Alv A. Dahl, Tone Tangen Haug, Dag Neckelmann) from Department of Public Health and Primary Health Care, Section for Preventive Medicine and Department of Psychiatry of Norway using Cronbalch’s alpha. In their study, the sensitivity and specificity for HADS of approximately 0.80 were very similar to the sensitivity and specificity achieved by the General Health Questionnaire (GHQ). Hence the review confirmed the assumption that HADS is a questionnaire that performs well in screening for the separate dimensions of anxiety and depression and caseness of anxiety disorders and depression in patients from nonpsychiatric hospital clinics

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Audio Visual Presentation:

The video will run for 10 minutes and must answer the following questions of:

a. WHAT IS THE PROCEDURE?

b. WHY IS THE PROCEDURE NECESSARY?

c. HOW IS THE PROCEDURE DONE?

d. WHAT ARE THE RISKS AND COMPLICATIONS OF THE PROCEDURE?

The video will be in full English language. The video will be validated by a Mass Communication professor by issuing a certificate. The video will be presented to at least 10 randomized selected persons outside the DORIS personnel before the actual test will be done. At the end of the video they must able to answer the above questions. During the actual test, video will be presented in groups through television in a separate room.

Data Handling and Analyses

The data will be collected directly from the patients by using HADS Scale questionnaires in DORIS at SPMC. Detailed information about the study will be given to each participant using English language and consent to participate will be obtained.

Over viewing of the questionnaire will be the first step, prior to data entry; this will be followed by designing an entry model using the computer Statistical Package for Social Science “SPSS”. The coded questionnaires will be entered into the computer by the researcher. Data cleaning will be done through checking out a random number of the questionnaires and through exploring descriptive statistics frequencies for all variables. All suspected or missed values will be checked by revising the available sheets.

The researcher will use Statistical Package for Social Science “SPSS” to analyze the research questions by using Chi square, ANOVA, and t test to answer the objectives. Also, the researcher used descriptive statistics to explore frequencies of all variables. Statistically significant values are considered at P values is equal or less than 0.05.

Sample Size Considerations

The sample size that will be used in the study is the total summation of the patients who will undergo breast, transvaginal and scrotal ultrasound who will give their consent and within the inclusion criteria from April to July of 2014.