The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
- Conditions
- AnxietyPainNurse's Role
- Registration Number
- NCT06370117
- Lead Sponsor
- Aydin Adnan Menderes University
- Brief Summary
The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.
H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
- Detailed Description
Design: It is a randomized controlled experimental study. Methods: This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access. The sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). Children were selected into groups by simple randomization method. Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. Introductory Information Form, Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data.
The data was analyzed on SPSS (Version 25, Chicago, IL, USA). The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed. Descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. The conformity of the measurement values to normal distribution was tested with "Shapirow-wilk" analysis. Pearson chi-square test was applied to the dependency relationship of frequency measurement values. One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups. Kruskal Wallis H-Test was used to compare groups that did not show normal distribution. Mann Whitney U test was used in further analysis to determine the difference between two independent groups. Wilcoxon test was used to test the significance of the difference between the scores of two related measurements. P values \<0.05 were considered statistically significant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- being between the ages of 4-12
- being willing to participate in the study,
- being accompanied by their parents (mother or father).
- Failure to establish vascular access on the first try
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Wong-Baker Facial Expression Rating Scale From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months Wong-Baker Facial Expression Rating Scale (WB-FRS): It was developed by Wong and Baker in 1981. This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing pain intensity, increasing from zero to five from left to right (0 points = very happy/no pain, 5 points = the most severe pain). The face on the far left has a smiling expression, indicating a pain-free state, while the face on the far right has a crying expression, corresponding to the most severe pain. The child is told to choose the face that best expresses his/her feelings.
- Secondary Outcome Measures
Name Time Method Children's Fear and Anxiety Scale From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months Children's Fear and Anxiety Scale (CCAS): McMurtry et al. It was developed by in 2011. In this scale, the child is shown a picture containing five facial expressions rated between 0 and 4 points. While 0 indicates no fear and anxiety; 4 represents the highest fear and anxiety \[0: neutral expression (no anxiety), 1: very little fear (very little anxiety), 2: some fear (some anxiety), 3: more fear (more anxiety), 4: possible shows the highest fear (severe anxiety).
Trial Locations
- Locations (1)
Bircan Kahraman Berberoğlu
🇹🇷Aydın, AYDIN-efeler, Turkey
Bircan Kahraman Berberoğlu🇹🇷Aydın, AYDIN-efeler, Turkey