This randomized clinical trial study was conducted at Shohadaye Khalij Fars Hospital in Bushehr –Iran from (7/30/2017) to (11/11/2017) Children age 6-12 who presented to the pediatric ER and required IV catheterization for infusion were randomized to intervention or standard of care. Inclusion criteria included full consciousness, the parent’s informed consent, verbal assent of the pediatric patient, and presence of a parent during the study. Exclusion criteria included taking pain and distress relief drugs (at least 6 hours before the procedure), presence of hearing, verbal, mental, or visual limitations that may interfere with picture book use, and any psychological distress requiring emergency IV therapy. Any patient who was randomized to the trial and had an unsuccessful initial IV catheterization was excluded and their data was not used in the final analysis.
Sample size:
To ensure sufficient power to detect differences between the groups, power analysis was used to estimate the sample size. We referenced a previous study (14) to predict a medium effect size for the intervention (effect size:0.84). To predict this effect size at a 5 % significance level (p < 0.05) and power of 0.90, we calculated that 32 subjects would be required in each group, We allowed for an attrition rate of 10 % giving a total sample size of 74.
This trial was approved by the institutional ethics committee, and written informed consent was obtained from all parents, along with verbal assent of all pediatric study subjects. The trial was registered with the Iranian Registry of Clinical Trials (IRCT) (code: IRCT2017041712830N22) on May 29, 2017.
Development of the Intervention:
The picture book intervention was developed by a graphic design postgraduate student and professors of Nursing and Midwifery at Bushehr University of Medical Sciences. This book contained six child-friendly drawings in which peripheral IV catheterization and infusion therapy are demonstrated in a step-by-step manner.
The main goal of this picture book was to orientate subjects to the steps, equipment, and expectations of IV catheterization and infusion.
Procedure
First, subjects were randomized using the convenience method. Then, they were randomly assigned into intervention or control groups through drawing from a collection of 74 cards (by the nurse) labeled from 1 to 74 after the parents and their children provided informed consent and verbal assent, respectively. The cards with even numbers were assigned to the control group (standard of care) and odd numbers were assigned to the intervention group. In the intervention group (n=36), one study subject and in the control group (n=38) three subjects were Discontinued due to unsuccessful initial catheterization (Refer to CONSORT FLOW CHART – figure2). Demographic information was provided by one of the parents. Once the patient received orders for Infusion requiring IV catheterization, the subject and a parent were brought to a treatment. The IV catheterization was performed by an experienced nurse. Research nursing students were trained on standardized OSBD_R scoring. Standard care in both groups for pain included verbal explanations, caressing, and presence of parents for support. Although school-aged children can tolerate parents’ absence, hospitalization may enhance their needs for security and parental presence (15). The procedure was divided into 4 phases. During the first phase, the nurse introduced themselves to the child and parent while preparing the intravenous IV catheterization equipment for 3 minutes. Then, between phases 1 to phases 2 the nurse oriented the subject to IV catheterization and infusion therapy by using the picture book. The control group received the same orientation without the picture book. Between phase 1 and 2, the nurse assessor the OSBD_R scorer left the treatment room; ultimately thought the scorer was not blinded as they could hear the treatment room proceedings. Phase 2 was considered the interval of time required for vein identification and preparation. Phase 3 included the entire IV catheterization procedure. Finally, phase 4 was the 3 minutes immediately following completion of the IV catheterization. No other pain interventions occurred in the either group. Due to the nature of the study, parents, nurses, and participants were not blinded.
Evaluation method
Distress was measured by Observation Scale of Behavior Distress_ Revised (OSBD_R), a standard scale to measure distress validated by Elliot et al (18) and utilized in in similar studies (12, 16). Specifically for an Iranian population, Ghazavi et al. confirmed the reliability of this scale (r=0.70) (17). The scale consists of eight behaviors indicating children distress resulting from therapeutic procedures. The behaviors and their scores include crying (1.5), screaming (4.0), restraining (4.0), and verbal resistance (2.5), and information-seeking (1.5), solicitation of emotional support (2.0), verbal pain expression (2.5) and flailing (4.0). A total score of 22 is considered the highest level of distress (17). Further, demographic information such as age, gender, birth order, parents’ education level, and residential area was collected.
The presence or absence of these eight operationally -defined behaviors were recorded by trained nurse observer (assessor) at 15-second intervals during the four phases.
The summed scores were summed during each 15-second interval and divided by the number of intervals to obtain a mean score for each phase. The phases are summarized in Figure 3.
Data analysis:
The data were analyzed by SPSS software (version 22). The Kolmogorov-Smirnov and Shapiro-Wilk tests were used to check the normal distribution of distress data. The OSBD_R scores were not normally distributed. Therefore, we used the Friedman test, a non-parametric test equivalent of the repeated measure analysis of variance, to examine changes in distress intensity over time.
In addition to descriptive statistics, Chi-square analysis compared the distribution of qualitative demographic variables between the two groups before intervention. The Mann-Whitney tests were used for comparing the mean (median) distress score between the two groups in each phase (?), and Friedman tests were used for evaluating changes of mean (median) distress score duration of intervention in intervention and control group respectively. The significance level was set at p<0.05 in all tests.