Clinical trial NCT06370117: The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
Official title: The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Nurse's Role
Keywords: Pain
Anxiety
Nurse's Role
Child
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 4-12
* being willing to participate in the study,
* being accompanied by their parents (mother or father).

Exclusion Criteria:

* Failure to establish vascular access on the first try

Primary outcomes:
measure: Wong-Baker Facial Expression Rating Scale
timeFrame: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months
Secondary outcomes:
measure: Children's Fear and Anxiety Scale
timeFrame: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Bircan Kahraman Berberoğlu
state: AYDIN-efeler
Study officials:
affiliation: Aydın Adnan Menderes Univercity
name: BIRCAN KAHRAMAN BERBEROĞLU
role: STUDY_CHAIR
References: