Can We Alleviate Pain Associated With The Peripheral Intravenous Catheterisation By Using Distraction Methods in Adults: A Randomised Controlled Trial
Phase: NA
Conditions: Pain
Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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05/08/2019 
Can We Alleviate Pain Associated With The Peripheral Intravenous Catheterisation By 
Using Distraction Methods in Adults? A Randomised Controlled Trial 
 
Study Protocol and Data Analysis 
1. Aims  
This study aimed to determine the effect of methods of distraction to mitigate pain associated 
with the PIC insertion procedure, thus improving patient satisfaction. Specifically, we 
examined such effect by playing 3D videos with virtual reality (VR) goggles and showing 
pictures to the patient containing distractive optical illusions. The study's hypotheses were as 
follows: 
a. Pictures including optical illusion and 3D video display with VR goggles reduce pain 
associated with needle entry during the PIC procedure compared to the control group. 
b. Pictures including optical illusion and 3D video display with VR goggles increase the 
satisfaction during the PIC procedure compared to the control group. 
2. Study Design and Setting 
The research was performed with a randomised controlled single-blind quasi-experimental 
study. It was conducted at the emergency unit of a training and research hospital in Ankara, 
Turkey, between January 18 and April 30, 2018. Before the PIC insertion, the patients were 
assigned to three groups. 
Group-1 (Control): No intervention was made during PIC insertion.  
Group-2 (Cards containing optical illusion pictures): Cards containing approximately six 
optical illusion pictures were shown to the patients and as a method of distraction during the 
PIC insertion procedure they were asked what they saw in these cards. Showing these cards 

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started at the beginning of the PIC insertion procedure and lasted approximately 2-3 minutes. 
(Seckel & Hofstadter, 2004). 
Group-3 (3D Video): Underwater 3D audial videos were played with visual reality (VR) 
goggles during PIC insertion until the procedure was completed. This show, starting at the 
beginning of the procedure, lasted nearly 2-3 minutes. VR goggles were used for 3D video 
playing in the research. VR goggles were applied by means of smart phones. After mobile 
phone placement in the pull chamber at the front side of the VR goggle, it was attached by a 
headband. The distance between the mobile phone and the object was adjusted specifically for 
the patient, and patient comfort was taken into account.  
3. Participants  
The study sample consisted of 120 patients aged between 18 and 65 years old, who ranked 4 
(less urgent) and 5 (non-urgent) based on Canadian Emergency Department Triage  and who 
had no visual, audial, or lingual disabilities, and no mental disorder. Only those patients who 
planned to have PIC insertion and were suitable for having PIC insertion at their antecubital 
location using 20 Gauge (pink) cannula were eligible. Patients who applied to the emergency 
service for acute pain and had not used analgesics within 24 hours before applying to the 
emergency service or had previously experienced multiple PIC procedures, were excluded 
from the research scope. Patients who refused to participate in the study, who were not 
eligible for 20 G PIC insertion, who were not in the age range of 18-65 years, and who could 
not be inserted PIC at the first time (n=98) were excluded from the study (Figure 1). The 
CONSORT checklist was followed in reporting this study. 
4. Sample Size Calculation 
The sample size was estimated by using the Medicres E-picos program (https://www.e-
picos.com/apps/power/sscm), and it was determined that a minimum of 117 patients were 

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needed [d (effect size/ effect width) =1.60, =0.05 =0.10, and power=0.95]. The study sample 
numbered 120 patients.   
5. Randomisation  
The randomisation method was used by layering according to gender. The patients were 
distributed into groups using the Medicres E-picos randomisation program (https://www.e-
picos.com/apps/calculation/rapg). Three groups of 40 patients each were generated, and 120 
patients were randomised into the control or experimental groups. 
6. Data Collection Tools  
The data were collected in the study scope by means of a data collection form consisting of 
the socio-demographic characteristics of the patients and the visual analog scale (VAS). VAS 
was used to evaluate pain caused by needle insertion. In the VAS of 10 cm length, “0” 
indicated no pain, and “10” indicated the severest pain. The scale between 1 and 10 was used 
to evaluate levels of satisfaction with the procedure. In this scale, “1” indicated the level of 
least satisfaction and “10” indicated the highest satisfaction level. The patients marked their 
pain and satisfaction levels on this scale.    
7. PIC Insertion Procedure  
The patient was seated in a position that suited the procedure. The arms were positioned 
below the heart level, when possible. An area in the antecubital location with no skin lesion 
was selected for PIC. The antecubital area and back of the hand are mostly preferred for the 
PIC. Because the antecubital vein, which is more commonly used in the PIC applications, has 
been reported to be less painful than the veins in the back of the hand in the literature, the 
PICs were all applied to the antecubital vein in the left arm. An autoguard shielded PEU-
Vialon (BD-Venflon, Becton Dickinson) was used as an PIC. Lateral holding sections of the 
cannula were positioned horizontally. The tourniquet was attached to the patient’s outfit at 5-
12 cm above the selected vein. The patient was asked to open and close his/her hand and 

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make a fist. The veins in the arm used for application were monitored and palpated. The 
selected location was cleaned by antiseptic solution and 1-2 minutes were allowed for drying. 
The PIC was held as the blade of the needle was facing upward. A location approximately 3-5 
cm below the point of insertion was pressed near the thumb of the empty hand to stabilize the 
vein, and the skin was stretched downwards. When the needle was inserted into the vein, the 
plastic portion was gently pushed through the inside of the vein. The tourniquet was undone 
and the catheter was fixed on the skin with a plaster. This application was completed within 
approximately 2-3 minutes.  All of the PIC insertion procedures were performed by the same 
researcher. The other researcher, who did not know which patient was in which group, 
collected the data on the assessment of PIC procedure-associated pain and satisfaction levels 
immediately after PIC insertion using face-to-face interviews.  
8. Ethical Consideration 
A permit (number 18/7 and dated 10/16/2018) from the Ethical Committee of the hospital 
where the research was conducted was received, and the hospital’s written permission was 
obtained. Moreover, the procedures to be carried out were explained to the patients prior to 
the procedure, and their written and oral consents were received.  
9. Data Analysis 
The collected data were analyzed by using the SPSS 21.0 package program. The variables 
determined by counting were shown in numbers and percentages, and the variables 
determined by measurements were shown as averages and standard deviations. T test and One 
way ANOVA were used in comparative statistics.  A p <0.05 level was accepted as an 
indication of significant difference in statistical decisions.  
 
 
 
 

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Figure-1.Diagram showing the flow of participants. 
Volunteers assesed for 
eligibility (n=218) 
Patients not eligible for 
the study ( n=98) 
 
Randomization    
(n=120)  
CONTROL GRUP 
(n=40) 
No intervention during a 
PIC procedure 
3D VIRTUAL REALITY 
GLASS (n=40) 
Received 
distraction 
looking through 3D virtual 
reality glasses 
Pain Assestment with 
Visual Analog Scale 
Pain Assestment with 
Visual Analog Scale 
Enrollment 
DISTRACTION PAINTING 
GROUP (n=40) 
Received 
distraction 
looking 
through 
distraction cards  
Allocation 
Allocation 
Follow-Up 
Follow-Up 
Analysis 
Analysis 
Analized (n=40) 
Excluded   Analysis 
(n=0) 
Analized (n=40) 
Excluded   Analysis 
(n=0) 
Analized (n=40) 
Excluded   Analysis 
(n=0) 
Pain Assestment with 
Visual Analog Scale