Hello, I am Debra Neiman, RN BSN. I have worked in Neonatal Care, at Beauregard Memorial Hospital, DeRidder for over four years. My college experience at Louisiana State University at Alexandria, resulted in a great deal of research papers, which are gathering dust in my office. My curriculum at Northwestern State University also added to this wealth of information. I hereby begin this series to provide a way to get this information to those in the nursing field and any other person with a passing interest in these subjects. Feel free to reference or use this infromation in your practice. However, Please respect my Copyright and do not "BORROW" for your HOMEWORK assignments.

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INDEX:

CHAPTER ONE - INTRODUCTION

CHAPTER TWO - LITERATURE REVIEW

CHAPTER THREE - METHODOLOGY

• Study Design
• Setting
• Population
• Data Collection
• Analytical Procedures
• Protection of Human Rights
• Summary

REFERENCES

APPENDICES:

• A - Postoperative Comfort Scale
• B - Consent Forms For Study
• C - Circumcision Consent Form
• D - Research Log Sample Sheet

The purpose of this quasi-experimental study is to determine if the pain newborns have following circumcision can be evaluated and rated using an objective assessment tool, the Postoperative Comfort Scale (Attia et al., 1987). Preoperative and postoperative scores are collected from two convenience sample groups of male newborns undergoing circumcision. The control group will receive no anesthesia, which is the current clinical practice. The manipulated group will receive subcutaneous lidocaine anesthesia. The following sections describe the study design, setting, sample, population, data collection, analytical procedures to be used, and protection of human rights.

The proposed study is a quasi-experimental design. A research study must contain the properties of manipulation, randomization, and control to qualify as experimental. A quasi-experimental design must involve manipulation of an independent variable, however, it may lack either randomization or the control group ( Polit & Hungler, 1993).

This study should be conducted during two phases. Each five month phase will utilize a convenience sample of newborns receiving elective circumcision. Newborns receiving circumcision during the first phase of the study will be assigned to the control group. This group will receive circumcision without anesthesia as is the current practice at the testing facility. Newborns receiving circumcision during the second phase of the study will receive anesthesia.

The research data and preoperative/postoperative scores will be recorded in a log with case number assignment to ensure patient confidentiality ( see Appendix D). The independent variable of the study is the use of subcutaneous lidocaine anesthesia. The dependent variable is the postoperative PCS scores of the manipulated group.

The study takes place in the newborn nursery of a southern community 102-bed acute care hospital. The newborn nursery is designated as Level I. The nursery has a staff qualified to care for uncomplicated deliveries and resuscitate, stabilize, and transport high risk newborn infants to the Level III nursery in a neighboring community (American Academy of Pediatrics, American College of Obstetricians & Gynecologists, 1988). This nursery averages thirty male newborn admissions per month with a 98% circumcision rate. The three obstetricians included in the study perform at least 98% of the circumcision procedures at this facility according to the nursery patient records.

The study uses a convenience sample of 125 to 130 male infants meeting the inclusion criteria. These are assigned to either the unanesthetized control group or the group receiving local anesthesia during elective circumcision procedure. Assignment is contingent on whether the procedure occurs in either the phase one or phase two time period of the study.

Inclusion criteria for research sample is defined as male newborns, less than 5 days old. Birth weight is at least 5 pounds and APGAR scores are at least 6 at 1 and 5 minutes. Delivery is by uncomplicated vaginal or cesarean birth. The newborn is without congenital or systemic complications and without previous surgical procedures.

Newborns will be excluded from the study if their preoperative pain scores are greater than 10, the circumcision procedure takes longer than 15 minutes, or if they experience excessive swelling, or bleeding during the circumcision.

A baseline Postoperative Comfort Scale score is obtained within the one hour preoperative period, before newborn is moved and restrained onto the circumcision board ( see Appendix A). The second score is obtained one hour after the newborn is removed from the circumcision board postoperatively. Both scores are obtained by the same evaluator and recorded in the unit's research log. The newborn is identified in the log only by an assigned number. The Postoperative Comfort Scale was developed by Attia and coworkers ( 1987) to measure postoperative pain in infants one to seven months old. An evaluation of ten behaviors is accomplished with a score of 0, 1, or 2 for each. A total score of 15 to 20 is considered to indicate adequate postoperative pain management (Bell, 1994).

Physicians and nurses participating in the circumcision will insure that signed consents for circumcision and participation in the study are documented on the patient chart ( see Appendix B & Appendix C). The specific physician performing circumcision using the plasti-bell device will have a minimum of one year experience performing the procedure and able to perform the procedure in less than 15 minutes.

Nurse evaluators will participate in a pre-trial study. Each evaluator will perform a preoperative scoring on the same ten newborns and again at one hour postoperatively. The ten newborns in the pre-trial study will not receive local anesthesia during their circumcisions as per the current practice at the facility. The scores will be statistically evaluated for significant differences among the evaluators' ability to provide reliable, valid rating of newborn pain with the Postoperative Comfort Scale assessment tool.

The data from the study groups will be analyzed using descriptive statistics including frequencies and percentages. The Chi-square test is an acceptable method of analysis and will be used to determine acceptance or rejection of the hypothesis. According to Polit and Hungler (1993), this test of statistical significance is used to determine whether a difference exists between two variables and to test the difference in two or more groups. The preoperative and postoperative PCS scores of the control group should indicate a significant level of pain response if the tool is reliable. The scores of the anesthesia group should have less difference based on the research that lidocaine subcutaneous anesthesia is effective in circumcision pain control ( Masciello, 1990). The preoperative scores of both groups should reflect no significant difference. The analysis should indicate a significance in the postoperative scores between the two groups. The level of significance for this Chi-square analysis is .05 with one degree of freedom ( Polit & Hungler, 1993).

The study is to be approved by the Hospital and Northwestern University's Institutional Review Boards. Each newborn included will have the permission of their pediatrician and the physician performing the procedure. Parents will read, verbalize understanding, and sign consent forms for the circumcision procedure and participation in the study. See Appendix B and Appendix C. Those selected for local anesthesia will also give written informed consent for use of 1% lidocaine on their newborn. Any newborn receiving a score of less than 15 at after one hour postoperatively will be assessed and physician order for analgesia, with acetaminophen infant drops 15 mg/kg dose every 6 hours for 24 hours, obtained as appropriate.

This chapter discussed the methodology for performing the study. Discussion included the quasi-experimental study design, setting, sample, and population to be included in the study. The methods of data collection, proposed analytical procedures, and protection of human rights was specified. Examples of the consents, Postoperative Comfort Scale assessment tool, and the research data log are provided in the appendices.

Copyright, ©1997 Debra Kay Neiman, RN BSN
E-Mail me at: crystalblue@usa.net