SUDANESE JOURNAL OF PAEDIATRICS

2021; Vol 21, Issue No. 2

ORIGINAL ARTICLE

Effect of external cold and thermomechanical stimulation on anxiety and pain during intravenous cannulation among children

Megha Gahlawat (1), Malar Kodi (2), Rupinder Deol (2)

(1) Nursing Officer, ESIC Hospital, Delhi, India

(2) Assistant Professor, College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India

Correspondence to:

Malar Kodi

Assistant Professor, College Of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India.

Email: malar.nur [at] aiimsrishikesh.edu.in

Received: 14 June 2020 | Accepted: 19 March 2021

How to cite this article:

Gahlawat M, Kodi M, Deol R. Effect of external cold and thermomechanical stimulation on anxiety and pain during intravenous cannulation among children. Sudan J Paediatr. 2021;21(2):162–172.

https://doi.org/10.24911/SJP.106-1590387019

ABSTRACT

Pain and anxiety are the most common and prevalent adverse stimuli experienced by hospitalised children. The most frightening and distressing source of pain and anxiety accounted for is due to venipuncture. This study aimed to assess the effect of cold and thermomechanical stimulation on pain and anxiety during intravenous (IV) cannulation among children. We conducted a prospective parallel-group randomised control trial in children who required IV cannulation. In the intervention group, external cold and thermomechanical stimulation was applied before 60 seconds, above 5 cm over IV cannulation site through Buzzy device, while the control group received routine care. Children’s level of anxiety and pain was assessed using the Children’s Fear Scale (CFS) and Wong-Baker Faces pain Scale (WBFS). Mean scores of the self-reported procedural level of pain were less in the intervention group as compared to the control group (2.80 ± 1.86, 7.47 ± 2.40). Median of procedural pain level showed a significant difference between the intervention and control group at p < 0.001, inferring that the Buzzy device strongly resulted in a reduction of perception of pain during the cannulation procedure. However, no significant difference was observed in the median of the procedural level of anxiety between the two groups (p = 0.208), stating that cold and thermomechanical stimulation did not affect the level of anxiety of children. Nevertheless, the combination of cold and thermomechanical stimulation through the Buzzy device did not have a significant impact on the procedural level of anxiety among children. Still, it could optimally alleviate the level of pain.

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KEYWORDS

Intravenous cannulation; pain; anxiety; children; cold; thermomechanical stimulation; Buzzy.

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INTRODUCTION

Hospitalisation is considered a traumatic event for children and might cause some unfavorable influences on the child. Children’s needs in hospital premises could be distinguished among three parts that include ample provision of care, protection from any hazard or harm, and shielding them from psychologically threatening circumstances. Nevertheless, hospitalised children are usually neglected and differentiated based on their age or care requirements or by both leading to adverse effects like pain, fear, distress, which might result in avoidance or delay in treatment [1-3].

About 10% to 20% of the child population avoids needle-related procedures because of anxiety. A quarter (25%) of children were estimated to have fear of needles, with the root of origin developed during early childhood [3]. An epidemiological investigation on prevalence and source of pain among pediatric patients stated that 49% of children had experienced the worst levels of pain significantly during hospitalisation, and only 21% had experienced the usual level of pain. Worst levels of pain were chiefly due to any medical procedure during hospitalisation [4-6].

Venipuncture and injection accounted for the most common distressing and painful events for hospitalised children. It was found that the pain due to intravenous (IV) cannulation insertion is second only to distress or pain related to disease condition [7]. Researches analysing observation and self-reported levels of anxiety and pain in the different age groups of children undergoing IV cannulation had consistently illustrated a high level of pain and distress in toddlers, pre-adolescents and adolescents [8].

A survey analysis of 171 children age 3 to 17 years reported that 36% of children 3 to 6 years and 13% of children 7 to 17 years had moderate-to-severe levels of pain during venipuncture [8]. Another study organised to evaluate anxiety on 223 children and adolescents undergoing venipuncture procedure illuminated that 50% of children reported a high level of anxiety in the absence of pharmacological or non- pharmacological interventions. Age-wise distribution depicted that 83% of toddlers had the maximum level of anxiety followed by 51% of pre-adolescents (7-12 years), and 28% of adolescents (above 12 years) [9,10].

It reflects that despite an abundance of information emphasising the intensity of pain associated with the needle-related procedure, there is a considerable frequency of untreated pain [11-13]. Thus health care practitioners should recognise the need to mitigate pain and distress in children during IV cannulation, or it would be buoyancy back with long term and immediate adverse outcomes.

Numerous evidence-based approaches used to combat the effect of anxiety and pain during IV cannulation. These approaches are classified broadly into pharmacological, psychological, procedural and physical approaches. Up until now, these methods had not gained universal precautions because of a lack of physical means for improving permeation of local anesthetics, high cost, long duration of the application and lack of clinical practice and training [13-16].

In the context of this, some researchers evaluated customary and ordinary maneuvers such as massage, vibration, cooling, or warmth on the perception of the level of anxiety and pain. Outcome stated that among all, vibration provides the most effective response. Still, the combination of thermomechanical stimulation and external cold had the most potent pain-relieving and distracting effect in inhibiting pain during the procedure [17,18]. Recently, impressive reductions in pain and anxiety levels were observed after using a combination of cold and thermomechanical stimulation among the pediatric population [19].

A Buzzy device recently developed and available in the biomedical market having a similar combination of cold and the thermomechanical stimulation. It is a battery-operated handheld device, which might allay pain and anxiety. It works on gate control theory, and mitigate pain by invigorating nerves with cold sensation to close pain gates and concomitantly stimulate A β mechanoreceptors with the technique of vibration [20]. Researches which explored this device in children had demonstrated effective pain-reducing and solace providing device, simultaneously confirming the use of this pioneering tool in the various clinical setting [21].

Across the globe, shreds of evidence had been enlisted regarding the efficacy of the device. However, literature reviews confirm no reports on the evaluation of this device in India among the paediatric cohort during IV cannulation. conversely, some studies supported the use of external thermo-mechanical stimulation on pain reduction alone or with some other methods like distraction cards, but mostly done with the study sample as adults in priority [22-24]. Therefore, there is a need to assess the effectiveness of external cold and thermomechanical stimulation on anxiety and pain during IV cannulation among children. The Buzzy device, if found effective in reducing the level of anxiety and pain among children during IV cannulation; then, it can be recommended to teach policies and protocols to use intervention (Buzzy device) in clinical settings during IV cannulation.

The present study aimed to assess the effectiveness of cold and thermomechanical stimulation by using a buzzy device on anxiety and pain during IV cannulation among children. Two hypotheses followed:

The level of pain during IV cannulation in the intervention group (external cold and thermo mechanical stimulation through Buzzy device) is lower than the level of pain in the control group.

The level of anxiety during IV cannulation in the intervention group (external cold and thermo mechanical stimulation through Buzzy device) is lower than the level of anxiety in the control group.

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MATERIALS AND METHODS

Design

A prospective open-label parallel-group randomised control trial to evaluate the effectiveness of cold and thermomechanical stimulation on anxiety and pain during IV cannulation among children. It hypothesised that using a buzzy device would considerably reduce pain and anxiety.

Setting and samples

This study included inpatients from pediatric units of All India Institute of Medical Sciences (AIIMS), Rishikesh in Uttarakhand between 20 August 2018 and 20 March 2019. Participants were required to meet eligibility criteria i) being in the 3 to12 years of age range ii) require IV cannulation and iii) undergoing first-time IV cannulation. Exclusion criteria were as follows i) who were having break or abrasion on the skin where the device would be placed, nerve damage in affected extremity critical or chronic illness, or neurodevelopmental delay. ii) Chronic pain due to an injury or disease, history of intake of any analgesic within the last 6 hours, history of syncope during the needle-related procedure; and iii) history of prior exposure to any device having a combination of both cold and vibration techniques.

Before the enrollment of participants, power analysis to estimate sample size was performed based on previous research. Sensitivity power analysis to estimate sample size was based on previous effect size, considering an alpha risk of 0.05 and power of 80%, using online G*Power software (http://www.gpower.hhu.de) [25]. Anticipating the fact that there would be some probability of drop out of samples (20%), a sample size 57 was determined to be adequate. Pediatric patients (N = 60) were selected by the researchers by Non-probability consecutive sampling technique based on inclusion criteria (30 in Intervention group 30 in Control group).

A computer-based random number generator was used to assign the patients into groups. Sequentially numbered opaque sealed envelopes (SNOSE) [26] were used for allocation concealment, and envelopes opened after obtaining written informed consent from parents and assent from children by a nurse who assigned them either in intervention or control group only at the time of IV cannulation. An open-label trial was used in this study, as children could visualise the device and no placebo was given. A CONSORT (Consolidated Standards Of Reporting Trials) flow diagram was prepared by the researchers [27] (Figure 1).

Buzzy device

An interventional device, resembling a bee or ladybug, was a reusable, battery-operated, handheld plastic 8 × 5 × 2.5 cm clinical tool (Figure 2). The Buzzy device has a combination of thermomechanical stimulation technique provided through the motor with a mechanism to offer external cold by attaching reusable ice wings underneath (http://buzzy4shots.com). Before every application, ice wings were solidly frozen. Buzzy device could be secured to limb via a tourniquet or by pressing and holding device manually [20,21].

Figure 1. CONSORT flow diagram.

Measurements and instruments

Two registered nurses were responsible for the procedure and data collection process. One of them, who had 12 years of experience in paediatric units, was responsible for all IV cannulation and applied devices. The investigator collected demographic information and determined pain intensity and anxiety levels from children.

Recorded information included age, gender, class/standard, number of siblings, birth order, type of family, religion, family income, system disorder, site of venous access and number of attempts done. Pre-procedural child’s level of anxiety was measured using the Children’s Fear Scale (CFS) before procedure recorded for both groups.

Figure 2. Buzzy device.

Children’s Fear Scale (CFS)

It is a standardised visual cartoon face scale tool used to determine the level of anxiety among children before and during IV cannulation [28]. This 5 point scale provides faces showing different amounts of being scared from not scared at all (0), a little scared (1), little bit more scared (2), bit more scared (3) andmost scared (4). It assesses self-reported anxiety level of children during IV cannulation, and all were instructed to look at these faces and choose the one that shows how scared they are during the needle insertion, and was also used to assess from the video taken during the procedure by another registered nurse. This tool was translated into the local language for better understanding to self-report; after that reliability was assessed by inter-rater method (r = 0.75)

Wong-Baker Faces Pain scale (WBFS)

It is a standardised visual cartoon face scale tool used to assess pain intensity among children during IV cannulation [29]. This 6 point scale provides faces showing different amounts of pain intensity from does not hurt at all (0), hurts just a little bit (2), hurts a little bit more (4), hurts even more (6), hurt a whole lot (8) and hurts worst (10). It assessed self-reported pain intensity of children during IV cannulation, and all were instructed to look at cartoon faces and choose the one that shows how much pain they felt during the needle insertion, and was also used to assess from the video taken during the procedure by another person. The descriptions of the tool were translated into the local language for better understanding and self-report; after that reliability was assessed by inter-rater method (r = 0.90).

Procedure

The patients who needed IV cannulation were identified based on their prescription for IV medication and infusion. Participants were taken to procedure room for cannulation, placed in the supine position maintaining verbal and visual contact with nurses in the ward procedure room. A registered nurse held the child hand to assess veins while another registered nurse focused on patient safety. In the intervention group, after cleaning the site according to hospital policy, the investigator placed the Buzzy device 60 seconds, over 5 cm proximal to a selected site of cannulation, and switched on the device,before the venous access attempt (Figure 3). Two nurses were selected and trained to perform IV cannulation for children.

The following steps were used for IV cannulation:

i) Identification of a suitable site (ideally dorsal and antecubital fossa of the hand) and size.

ii) A tourniquet was applied proximal to the selected site and cleaned with an alcohol swab.

iii) The cannula was inserted at an angle of 10-15 degrees to the skin with the bevel upright, just distal, and along the line of the vein.

iv) Stylet removed and secured the cannula.

IV cannulation procedure was considered successful if blood started running into an IV needle. If the cannulation was not successful at the first attempt, then the second attempt was made. During subsequent attempts, the Buzzy device was repositioned from the beginning following the same as previous. Procedural level of anxiety and pain were assessed through self-report immediately after the procedure by using the CFS and WBFC (Figure 4). The same was assessed with the help of a video, which is recorded during the procedure for more reliability of the data. The device was cleaned with alcohol swabs before switching to another participant. The ice pack was taken out of the freezer just before each IV cannulation. The Control group received routine care as per the hospital policy.

Data analysis

Collected data were coded and entered in Microsoft excel sheet and analyzed using Statistical Package for the Social Sciences for Windows, version 23.0. Descriptive statistics were presented as frequency and percentage for categorical variables and as mean and standard deviation for continuous variables for demographic characteristics of children. Chi-square or Fisher exact test were used to assess homogeneity between the intervention and control group; assumption of normality was determined by the Kolmogorov-Smirnov test. Comparison of the procedural level of anxiety and pain was made by Wilcoxon signed-rank test, and Mann-Whitney-U test. Comparison of self-reported and video analyzed procedural level of anxiety and pain was done using the Mann-Whitney-U test. Association between level of anxiety and pain among children with their socio-demographic variables was performed by assessing median, mean rank calculated via Kruskal Wallis h test and Mann-Whitney-U test, wherever applicable; and p < 0.05 was considered to be statistically significant.

Figure 3. Data collection procedure.

Figure 4. Procedural timeline.

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RESULTS

The final cohort included 60 patients (45 males and 15 females), and the mean age of children in the intervention group was 8.80 ± 2.90 as compared 8.10 ± 2.41 years in the control group. There are no statistically significant differences between intervention and control groups regarding demographic characteristics (Table 1).

Research hypothesis 1: level of pain

The pain levels of the two groups are summarised in the Table 2. Self-reported procedural level of pain (2.80 ± 1.86) and video analysed pain level (4.00 ± 2.46) in the patients was found to be significantly less in the intervention group as compared to control group (7.47 ± 2.40, 7.67 ± 2.57), respectively.

Research hypothesis 2: level of anxiety

Comparison of the pre-procedural and procedural level of anxiety shows significance at p = 0.016 (Table 3 ). Therefore, it provided the impression that considerable reduction occurred in the level of anxiety in both intervention and control groups during the procedure. Comparison of self-reported and video analysed procedural level of anxiety revealed that the level of anxiety as reported by child, and as interpreted by video, were significantly indistinguishable both in intervention and control groups at, respectively, p = 0.59 and 0.06. Also comparison of self- reported and video investigated procedural level of pain showed that the level of anxiety as reported by child and as interpreted by video were significantly identical both in intervention and control group at p = 0.07 and 0.59, respectively (Table 4).

Table 1. Demographic characteristics of children.

Variables	Intervention group (n = 30)	Control group (n = 30)	Fisher’s exact test	df	p value
	n (%) or M ± SD (Minimum-Maximum)	n (%) or M ± SD (Minimum-Maximum)
Age (years)	8.80 ± 2.90 (3-12)	8.10 ± 2.41	02.37	04	0.70
Gender
Male	23 (77%)	22 (73%)	00.01	01	1.00
Female	07 (23%)	08 (27%)
Site of venous access (in hand)
Dorsal	28 (93%)	26 (87%)	00.30	01	1.00
Antecubital	02 (07%)	04 (13%)
Number of attempts
1	28 (93%)	24 (80%)	01.02	01	0.85
2	02 (07%)	6 (20%)

df = degrees of freedom; M = mean; Max = maximum; Min = minimum; n = number; SD = standard deviation.

Table 2. Comparison of self-reported and video procedural pain level.

	Intervention group (n1 = 30)	Control group (n2 = 30)	p-value
	Mean ± SD	Mean ± SD
Self-reported procedural pain	2.80 ± 1.86a	7.47 ± 2.40b	0.59
Video analyzed procedural pain	4.00 ± 2.46a	7.67 ± 2.57b	0.06

^aRange score: 0-8; ^bRange score: 2-10.

M = mean; n = number; SD = standard deviation.

Table 3. Comparison of the pre-procedural and procedural level of anxiety.

	Median (IQR)	Z-valuea	p value
Control group (n = 30)
Pre-procedural Procedural	0 (0-2) 2 (0-3)	-2.94	0.003*
Intervention group (n = 30)
Pre-procedural Procedural	0 (0-1) 1 (0-2)	-2.55	0.208

^aWilcoxon signed rank test.

^*Significant at (p < 0.05).IQR = Interquartile range

Table 4. Comparison of self- reported and video analyzed the procedural level of anxiety and pain.

Variables	Interventional group (n1 = 30)		Man-Whitney-U	Z-value	p value	Control group (n2 = 30)		Man-Whitney-U	Z-value	p value
	SR	VA				SR	VA
	Median (IQR)					Median (IQR)
Anxiety	1 (0-2)	0 (0-2)	416.00	-0.53	0.59	2 (0-3)	3 (0-4)	325.00	-1.90	0.06
Pain	2 (2-4)	4 (2-6)	335.00	-1.77	0.07	8 (6-10)	8 (7-10)	416.00	-0.52	0.59

IQR = Interquartile range; SR = Self-reported; VA = Video analysed.

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DISCUSSION

Pain is more common during invasive procedures that are performed within hospitalisation, thus provoke fear and anxiety, especially needle anxiety can lead to worry [6,7]. Anxiety and pain are common in hospitalisation; predominantly during IV cannulation. Certainly it’s a big challenge for pediatric nurses and health care workers to do cannulation without pain in children; since family members and children wish to have painless cannulation [30-32]. Reduced anxiety and painlessness will also facilitate better clinical outcomes [9]. The American Society for Pain Management Nursing recommends that optimal pain control must be provided before and during any painful procedure [33,34]. Hence, measures to reduce pain, especially non-pharmacological approaches, are recommended to control pain and anxiety levels in children.

This study was conducted to explore the effectiveness of cold and thermomechanical stimulation via a buzzy device on the level of pain and anxiety in pediatric patients during IV cannulation. Sixty children were enrolled in the study. The mean age of children in the intervention group was 8.80 ± 2.90 years as compared to 8.10 ± 2.41 years in the control group. Most of the children were admitted with a provisional diagnosis related to gastrointestinal disorder followed by fever problems, and respiratory problems. Dorsal region of hand was the most common site chosen for IV cannulation in both groups with the majority completed in first attempt except for 7% and 20% in intervention and control group, respectively, who require second attempt for successful cannulation.

As reported by Redfern et al. [35] and Susam et al. [36], the mean score of child-reported pain was significantly less as compared to control group, i.e. (3.56 vs. 5.92, p = 0.015). Still, no significant impact was seen on the level of anxiety while assessing the outcome of Buzzy during vaccination. Similarly, in the present study, there is no significant effect of cold and thermomechanical stimulation on the level of anxiety in children undergoing IV cannulation between intervention and control groups. However, studies done by Susam et al [36] and Canbulat et al. [37] showed that the level of anxiety in the intervention group (0.58 vs. 0.73) was significantly lower than the control group (p = 0.001) which is contradicting the findings of the study. Comparison of median self-reported and video analysed procedural level of pain among children during IV cannulation conferred that level of anxiety as reported by child and as analyzed by video were significantly identical both in intervention and control group. Moadad et al. [34] and Baxter et al. [38] also showed similar results that no noteworthy difference was observed between the median of the self-reported level of pain (0, p = 0.28) and median of video observed behavior of children during cannulation (0, p = 0.77). Notably, this study showed that the level of pain and anxiety were significantly reduced by using this device.

Limitations

Inability to mask intervention participants who were not blinded to an interventional device, which might have foster biases in ratings. The device was also seen, so an open label trail was undertaken. Second observation during IV cannulation procedure could reduce detection bias and yield better reliable data. Also, the satisfaction scores could have evaluated children, pediatric nurses, and parents; but due to time constraints, it was not included.

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CONCLUSION

The study supported the Buzzy device as an emerging non-pharmacological pain management tool for minimising pain during IV cannulation. Although the device did not have a significant impact on the procedural level of anxiety among children, the combination of cold and thermomechanical stimulation optimally reduces pain. This device was easy to handle, reusable, time- saving, with quick-acting option, which could limit pain sensation among children during IV cannulation. However, it is also essential to assess the conditions such as the lack of access to each institution and the cost factor. Based on the findings of the study, it is recommended that policies/protocols regarding the use of a combination of external cold and thermomechanical stimulation (Buzzy device) ought to be provided for clinical settings.

Further research studies can be conducted on a larger sample for better authentication of results. Studies can be done to evaluate the optimal age for the administration of the Buzzy device. Also, research to determine parental and nurse’s satisfaction to the device, along with the impact of physiological parameters are recommended.

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ACKNOWLEDGEMENT

The authors would like to thank the nurses for their help, as well as the pediatric patients and their parents for participating in this study.

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CONFLICT OF INTERESTS

The authors declare no conflict of interest in this study.

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FUNDING

Self.

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ETHICAL APPROVAL

Written permission was obtained from Institutional Ethical Committee (76/IEC/PGN/2018, AIIMS/IEC/18/254). The trial was designed according to and adhered to detailed guidelines in CONSORT [27] and registered (CTRI/2018/10/015950). Informed written consent was obtained from the parents of children. Verbal assent was taken from children 3 to 6 years of age, and written assent was taken from children 7 to 12 years of age. Parents and their children were assured of their rights to refuse to participate in the study or withdraw their consent at any stage and assured for anonymity and confidentiality of data.

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