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Completed

NCT Number: NCT06370117

The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Nurse's Role Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bircan Kahraman Berberoğlu

Aydin, AYDIN-efeler, 0900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buzzy

Behavioral

Before the procedure; 60 seconds before starting the vascular access process, the Buzzy® tool was placed in the procedure area and cold and vibration application was started. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site.

Music video listening

Behavioral

Before the procedure; A music video was played 60 seconds before starting the intravenous access procedure.

Buzzy+ Music video listening

Behavioral

60 seconds before starting the vascular access process, a music video was played and cold and vibration application was started with the Buzzy® tool. 60 seconds before the procedure began, the Buzzy® tool was placed on the procedure area and cold and vibration application was initiated. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed midway between the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site.

Primary outcomes

  1. Wong-Baker Facial Expression Rating Scale

    Time frame: 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 outcomes

  1. Children's Fear and Anxiety Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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