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Predicting Pediatric Distress During Radiation Therapy Procedures: The Role of Medical, Psychosocial, and Demographic Factors

^a Divisions of Behavioral Medicine
^d Anesthesiology and Departments of
^e Radiation Oncology
^c Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee
^b Department of Pediatrics, University of Tennessee College of Medicine, Memphis, Tennessee

	ABSTRACT

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OBJECTIVES. The purpose of this work was to identify demographic, medical, and psychosocial variables that predict radiation therapy–related distress among pediatric patients with cancer.

PATIENTS AND METHODS. Seventy-nine children between the ages of 2 and 7 years were consecutively enrolled in the study. Radiation therapy–related distress was measured by rates of anesthesia, observed behavioral distress, and heart rate.

RESULTS. Younger age and higher observed behavioral distress predicted the use of anesthesia, higher baseline heart rate predicted lower initial observed behavioral distress, and prone treatment position was associated with increases in both observed behavioral distress and heart rate relative to baseline.

CONCLUSIONS. Modifiable treatment and psychological variables directly relate to pediatric radiation therapy–related distress. Implementation of developmentally appropriate and cost-effective interventions to reduce procedural radiation therapy distress is warranted.

Key Words: pediatric distress • radiation therapy • noninvasive medical procedures

Abbreviations: RT—radiation therapy • HR—heart rate • OBD—observed behavioral distress • ECOG—Eastern Cooperative Oncology Group • OSBD—Observation Scale of Behavioral Distress

Radiation therapy (RT) is a curative form of therapy used to treat a variety of pediatric tumors. It can be used alone or in conjunction with surgery and chemotherapy for disease control and to preserve normal tissue structure and function.¹ RT is typically delivered to patients once daily, 5 days per week, over a continuous course of treatment typically lasting from 5 to 7 weeks. Before treatment, a 30- to 90-minute planning session (described as "simulation") takes place to construct customized immobilization devices, localize radiographically the region to be treated, position the patient for treatment, and perform measurements to simulate the geometry of the treatment machine (ie, linear accelerator).

Distress reactions occur frequently among pediatric patients undergoing RT despite the noninvasive and painless nature of the treatment.^2,3 Distress reactions may occur as a result of unfamiliarity with the procedure and medical staff, painful experiences with previous medical procedures, separation from parents and caregivers, or from the sights and sounds of the RT equipment.⁴ RT requires that patients be immobilized for extended time periods for optimal treatment delivery to take place. Daily reproducibility of patient positioning allows for more precise irradiation of the tumor site with subsequent reductions in healthy tissue irradiation and acute and chronic adverse effects.⁵ When children are unable to maintain a fixed and reproducible position required for treatment, the success of RT is compromised, and anesthesia will likely be required.

Although sedating/anesthetizing children for RT is generally considered safe, completion of RT procedures without pharmacological intervention is preferred, because repeated sedation, high dosages of sedatives, multiple drug use, and general anesthesia all increase the risk of medical complications among children.^6–8 These complications may include transient hypoxia, laryngeal spasm, airway obstruction, sinus arrhythmia, prolonged profound sedation, and respiratory depression.^9,10 In some cases, longer recovery times may result in reductions in available patient quality time throughout the course of treatment. Patients who are able to comply with RT without pharmacologic intervention avoid both the eating and drinking restrictions, as well as the physical adverse effects, associated with receiving anesthesia. Therefore, in light of these risks, it is preferable to implement behavioral approaches to manage RT-related distress as an alternative to pharmacologic management whenever possible.

When children undergo complex or demanding medical procedures, a decision must be made as to whether pharmacologic intervention is warranted for assisting the patient with procedural compliance. In making their decision, the medical team will undoubtedly be influenced by a number of demographic, medical, child, and parental psychosocial variables that have been found to be associated with increases in pediatric procedural distress. Among invasive procedures, younger age,^11–15 female gender,^14,16–18 high child anxiety,^19,20 high expectations of distress,^15,21,22 and high parent anxiety^22–27 have been found to increase children's procedural distress. Interestingly, reports of pediatric distress persist even when deep sedation is used during medical procedures. For example, 17% of pediatric leukemia patients undergoing repeated sedations for lumbar punctures and bone marrow aspirations reported fear specific to sedation, 65% complained about fasting before the procedure and waiting for the medical staff, whereas 39% complained that too many people were in the room during the sedation initiation.²⁸

Much less is known about factors related to pediatric distress during noninvasive procedures such as RT. Harned and Strain²⁹ found that younger age was associated with increased sedations during MRI procedures, particularly among those <10 years of age. Similarly, Byars et al³⁰ found that younger age, male gender, and neurologic impairment were associated with sedation failure among pediatric patients undergoing MRI procedures. Specific to RT, younger age has been found to be the strongest predictor of increased anticipatory distress among children aged 2 to 7 years awaiting their initial RT procedure.³

The purpose of this study was to identify child and parent sociodemographic, medical, and psychosocial variables that best predict children's distress during RT simulation. To date, no studies have empirically examined predictors of RT-related distress and sedation among pediatric patients with cancer. Furthermore, this novel study examines both initial procedural distress (when clinicians typically make sedation decisions) and total procedural distress, as they relate to sedation, heart rate (HR) and observed behavioral distress (OBD) outcomes.

	METHODS

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Participants
Eighty parents and active patients between the ages of 2 and 7 years, who were receiving outpatient RT in the Department of Radiation Oncology at St Jude Children's Research Hospital, were consecutively enrolled on this institutional review board-approved protocol. Preschool- and early school-aged children were chosen to participate in this study, because they have historically been most frequently anesthetized but have also evidenced successful completion of RT simulation and treatment without pharmacologic intervention. The presented study was part of a larger 2-group randomized clinical trial designed to reduce RT-related distress among pediatric patients with cancer. The details and findings of this larger study are reported elsewhere.³¹

Eligible patients were those who had a primary diagnosis of malignancy, aged 2 to 7 years at the time of RT simulation, used English as their primary language, had no previous experience with external beam irradiation, and were functioning at a level at which they could tolerate RT intervention. Accordingly, eligible patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status rating of 0 (no physical debilitation or functional impairment) to 3 (moderate physical debilitation or functional impairment) as reported by the child's physician. One-hundred percent of the families approached for this study participated. One participant was excluded from the analysis, because he arrived to the RT clinic already sedated due to an earlier procedure. As a result, analyses were completed on a sample of 79 participants. Table 1 presents the demographic and medical features for the study group, including gender, race, socioeconomic status,³² age at simulation, diagnosis, functional status, years since diagnosis, RT treatment position, and parent state anxiety.

OBD
Based on the Observation Scale of Behavioral Distress (OSBD) of Jay et al,¹⁶ a behavioral checklist modified for use within the RT setting was used to code behavioral distress experienced during the RT simulation. The OSBD checklist is composed of 12 operationally defined behaviors and is similar in content to other behavioral observation scales and methodologies for rating and scoring children's behavioral distress during invasive medical procedures.^17,21,33 Observed distress behaviors have been reliably coded using the OSBD during both invasive¹⁶ and noninvasive³⁴ pediatric procedures with correlation coefficients being reported in the 0.72 to 0.99 range across raters.

Trained clinical observers independently rated patients' distress behavior and recorded the frequency of these behaviors during 5-minute intervals over a 10-minute baseline period and simulation procedure. The behavioral ratings were grouped into 4 categories, which included verbal (eg, "I'm scared"), vocal nonlanguage (eg, crying, screaming, or yelling), body movement/physical manifestations of distress (eg, physical resistance, facial grimacing, or hitting/kicking), and a summed total of these 3 domains. Three master's level psychologists were trained until observations in each category yielded an interrater reliability correlation coefficient of 0.80 over 6 consecutive procedures.

HR
Often, physiologic arousal has been included as a measure of distress/anxiety in studies examining pediatric invasive and noninvasive medical procedures; however, there is a lack of consensus as to whether HR is a valid, reliable, and sensitive measure of distress.^35–40 In this study, a Nellcor N-20 Series handheld pulse oximeter recorded the HR of patients every 30 seconds via an oxisensor attached at the patient's finger. This pulse oximeter yields reliable measurement of HR ranging from 20 to 250 beats per minute ±3.

State-Trait Anxiety Inventory
Parents of children rated their own anxiety via completion of the State-Trait Anxiety Inventory.⁴¹ The State-Trait Anxiety Inventory, a standardized inventory with well-documented clinical validity, is designed to measure state and trait anxiety in adults. Only the State Anxiety Scale was used in this study. The State Anxiety Inventory is composed of 20 self-report items and evaluates how the respondent feels "right now at this moment." The median coefficient for the State Anxiety Scale is .93, and test-retest correlations range from .31 to .47, reflecting the transitory nature of state anxiety. Evidence of validity for this scale is shown by its correlation with other widely used measures of anxiety in adults.

Procedure
Parents of eligible children were approached and presented with the details of the study as they initially arrived with their families for the RT simulation in the Radiation Oncology Clinic at St Jude Children's Research Hospital. At that time, informed consent was obtained according to institutional guidelines. After study enrollment, participating patients were then observed in a clinic examination room via video monitor, and 10 minutes of baseline data (HR and OBD) were collected immediately before the patient's RT simulation. During this time, participating parents completed the self-report anxiety inventory. After completion of baseline assessment, the child was taken from the clinic examination room to the RT simulation room, which contained a fluoroscopy unit with a couch and radiograph (including detector). At this time, immobilization devices were constructed, and radiographs were obtained in the treatment position localizing the region to be treated.

Logistics of Observations and Measurements
OBD, HR, and parent-report data were collected during baseline and simulation time points. All of the behavioral observations were made via television monitors located outside the clinic examination and RT simulation rooms, whereas physiologic HR data were collected via a pulse oximeter. Data collection was initiated immediately upon the child's entrance into the targeted medical room (ie, clinic examination room or the RT simulation room). Once in the RT simulation room, children were given a minimum of 15 minutes to voluntarily comply with the RT procedure. If the child was unable to comply by that time, sedation or anesthesia was prescribed. Simulation, HR, and OBD data were collected until the anesthesia agent was administered or until the simulation procedure was successfully completed.

Data Organization and Reduction
Data were organized to reflect 2 phases of RT simulation. The initial phase scores included the first 3 minutes of HR data and the first 5 minutes of OBD during both baseline and simulation phases of RT. Initial response to a novel treatment room and the impending procedural demands faced by the child has traditionally been associated with considerable behavioral distress and anxiety,¹¹ as well as decision-making, with regard to procedural compliance. As such, this phase of treatment was considered conceptually distinct from the overall treatment, and data from this interval were considered a separate time point in analysis. The total phase scores include cumulative HR and OBD data collected during the entire baseline and simulation procedures. Distress data (initial and total phases) were reduced to OBD and HR per minute to control for differences in time observed in treatment.

Simulation HR data were not collected for 14 of the participants in our sample because of operator error and, in 1 case, parent refusal. As a result, change scores could not be computed for those participants. As such, HR analyses were conducted with data from 65 subjects.

Statistical Approach
General linear regression model was used to assess whether the following factors (age, gender, race, sedation, treatment position, diagnosis, baseline distress total mean, time since diagnosis, ECOG, treatment group, and parent anxiety baseline) were associated with OBD and HR. The above factors were assessed one at a time with each outcome independently. The factors significant at an level of .10 were put in the final multiple-regression model. The factors significant at an level of .05 were considered to affect the outcomes (initial OBD and HR and total OBD and HR). Stepwise logistic regression was used to assess whether the following factors (age, gender, race, diagnosis, time from diagnosis, ECOG, treatment position, total HR, total OBD, observed time during simulation, parent state anxiety baseline, and treatment group) were associated with the sedation rate. All of the factors significant at the .10 level were entered into the multiple regression model. The criteria of significance level to remain in the model were Ps < .05 based on the likelihood ratio test. Two-sided P value was reported.

	RESULTS

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Anesthesia
At simulation, 62% (49 of 79) of patients required pharmacologic intervention to complete the procedure. Of the 49 participants sedated, 92% received propofol-delivered deep sedation, 6% received intravenous moderate sedation, and 2% received light sedation delivered via par oral sedative. Stepwise logistic regression was used to determine the factors that were significantly associated with anesthesia status (occurrence versus nonoccurrence) at simulation. Age at simulation, gender, race, diagnosis, time from diagnosis, ECOG score, treatment position, total simulation HR mean, total simulation OBD mean, parent state anxiety, and treatment group were included in the final model estimate. Eight patients who received total body irradiation and were treated in both prone and supine positions were excluded from these and all other regression analyses. Age and total simulation OBD scores were significantly associated with anesthesia status. With each 1-year increase of age, patients were 0.09 times less likely to be anesthetized (P < .03), whereas those patients with a 1 unit increase of total OBD during simulation were >1000 times more likely to be anesthetized (P < .02). Logistic regression results are reported in Table 2. Finally, children who were anesthetized experienced significantly more observed distress behavior both at baseline (P < .001) and simulation (P < .0001) as compared with nonsedated patients.

Means and SDs of OBD scores (initial phase and total) obtained at baseline and simulation, as well as mean change scores (simulation – baseline) for the group, are provided in Table 3. A general linear regression model was used to determine the effect of selected covariates on the initial- and total-phase OBD change scores. Age at simulation, gender, race, diagnosis, time since diagnosis, ECOG score, sedation status, treatment position, mean baseline HR, treatment group, and parent state anxiety were examined as covariates. Time observed in treatment was included for the total OBD analysis only. With initial-phase OBD change score as the dependent variable, only baseline HR was found to be significantly associated with the change score (P < .03). Patients with higher mean baseline HRs exhibited significant decreases in OBD from the initial baseline phase to the initial simulation phase. The final equation, including treatment position and mean baseline HR, accounted for 13% of the variance in the initial-phase OBD change scores (F_2,68 = 4.70; P < .02).

Age, gender, race, diagnosis, time since diagnosis, ECOG scores, sedation status, treatment position, mean baseline OBD, and parent state anxiety scores, as well as treatment group, were examined as covariates associated with HR change score outcomes. Time observed in the simulation session was added as a covariate to the model for total HR mean change scores only. Results from the general linear regression model revealed that the treatment position was significantly associated with increases in HR from the initial phase baseline to initial phase simulation (P < .04). Patients treated in the prone position had a significantly greater increase in the initial-phase change scores of mean HR during the initial phase as compared with those treated supine. The final model, including treatment position and sedation status, accounted for 23% of the variance in the initial-phase HR change score outcome (F_3,54 = 5.28; P < .003).

The final model predicting changes in total mean HR from baseline to simulation included age at simulation, treatment group, treatment position, total mean of baseline OBD, time observed during simulation, and sedation status as independent variables. Treatment position was the only significant covariate associated with total mean HR changes. Those treated in the supine position experienced significantly smaller changes in total mean scores of HR as compared with those treated prone (P < .02). Procedural and behavioral variables accounted for 49% of the variance (F_6,51 = 8.18; P < .001). Regression results for this model are reported in Table 5.

	DISCUSSION

TOP ABSTRACT METHODS RESULTS DISCUSSION REFERENCES

Patients who were treated in the prone position seemed to be at increased risk for RT-related distress compared with patients treated in the supine position, as reflected by significant increases in HR and OBD at simulation. This suggests that children undergoing RT simulation should be treated in the supine position whenever possible. The fact that patients in the prone position had a more limited field of vision during the procedure may partially account for the increased distress levels. To reduce OBD and, hence, the likelihood of sedation among those children treated in the prone position, it may be advantageous to use RT immobilization devices with transparent materials or facial openings. These changes to the equipment may improve patient comfort by allowing better visibility and reducing perceptions of air flow constriction, 2 factors that likely contributed to the increased distress experienced by prone-treated patients.

Another option for reducing RT-related distress includes the use of behavioral and cognitive-behavioral interventions. Techniques such as modeling, distraction, desensitization, positive reinforcement, relaxation, visual imagery, practice, education, and so forth have been found to significantly reduce RT-related distress.^4,31 Klosky et al,³¹ for example, report on a randomized clinical trial that evidenced the efficacy of a cognitive-behavioral intervention in reducing RT-related distress similar to that of orally administered diazepam (Valium) among preschool- and school-aged children.³⁶ In a smaller study, Slifer² reports that 82% of pediatric patients between the ages of 2 and 7 years were able to complete RT simulation and treatment successfully without any use of sedation after completing a behavioral intervention. Because developmental trends in our sample suggest that rates of sedation are primarily a function of younger age and increased OBD, it is also important that the design and implementation of behavioral interventions be developmentally appropriate and individualized to meet each child's specific needs. For example, auditory-based distraction/relaxation using age appropriate language and themes should be most useful in reducing RT-related distress among younger patients with visual deficits, whereas visually based modeling or distraction should be most useful for pediatric patients experiencing auditory deficits.

Although the results were generally similar between the initial phase and total RT simulation, some differences did emerge. Specifically, we found that increased initial baseline HR predicted lower initial OBD in the simulation room. It may be that a select group of children experienced anticipatory procedural anxiety as discussed in Blount et al¹¹ and Tyc et al.³ Traditionally, changes in RT-related OBD begin as the simulation procedural demands increase (ie, parent leaves the room, child positioning is attempted, alone with unfamiliar medical staff, etc), and this type of distress may have been best captured by the total, as opposed to the initial, OBD score. It may be advantageous to design interventions to take place both before and during RT simulation for the most meaningful reductions in RT-related distress to occur.

Although the results of this study represent a positive step in identifying factors that contribute to children's RT-related distress, the findings should be interpreted in the context of the study's limitations. Sedation histories and number and type of previous medical procedures experienced by the patients in our sample were not assessed, although these variables may influence the child's distress and response to the RT procedure. Likewise, we did not assess children's perceptions of their own distress because of the young age of the study participants and their inability to provide valid self-reports. True natural baseline HR and behavioral data (ie, at home or in their natural setting the day before the RT simulation) were also not obtained, making it difficult to examine "base rate" behavior and HR levels that could potentially influence our results. Initial distress may have also been overrepresented in the study, because total procedural distress scores included initial distress as well. The results discussed here should not be generalized beyond the parameters of the study: children 2 to 7 years of age undergoing RT simulation.

The results of our study indicate that both fixed and modifiable variables directly relate to distress as experienced by pediatric patients with cancer undergoing RT simulation. Developmentally appropriate interventions designed to target these variables among preschool- and early school-aged children are clearly warranted. Furthermore, incorporation of empirically tested strategies to improve child procedural coping (ie, filmed modeling, distraction, education, etc) are needed to maximize successful outcomes as evidenced by reductions in distress and rates of sedation. Future studies examining the efficacy of such proposed interventions are needed and should be tested in both the RT-simulation and treatment settings.

	ACKNOWLEDGMENTS

 
This study was funded in part by a grant from the Starlight Starbright Foundation, the American Lebanese Syrian Associated Charities, and the National Cancer Institute (Cancer Center Support grant CA21765).

We thank nursing, radiation therapy, and anesthesia personnel for their assistance with this study.

	FOOTNOTES

 
Accepted Nov 1, 2006.

Address correspondence to James L. Klosky, PhD, Division of Behavioral Medicine, MS 740, St Jude Children's Research Hospital, 332 N Lauderdale, Memphis, TN 38105-2794. E-mail: james.klosky{at}stjude.org

The authors have indicated they have no financial relationships relevant to this article to disclose.

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