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

NCT06370117 | Completed DMC

• 1 other identifier: Aydın Adnan Menderes
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Nurse's Role

Keywords

Pain; Anxiety; Nurse's Role; Child

Outcome Measures

Primary Outcomes (1)

• Wong-Baker Facial Expression Rating Scale

  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.

  From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months

Secondary Outcomes (1)

• Children's Fear and Anxiety Scale

  From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months

Study Arms (4)

control group (n= 34)

NO INTERVENTION

Control group (n=34) Routine vascular access was performed on the children in the control group. Apart from this, no other application was made. Before the procedure; Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Routine vascular access was performed. A stopwatch was used for the procedure time and the procedure time was recorded. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again.

Buzzy Group (n= 34)

EXPERIMENTAL

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. As soon as the vascular access was established, the Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Application with the Buzzy® tool continued throughout the process. A stopwatch was used to time the procedure and the Buzzy® tool was removed when the procedure was completed. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again.

Behavioral: Buzzy

Music video listening group (n= 34)

EXPERIMENTAL

The children in study group II were listened to music starting from 60 seconds before the vascular access procedure until the procedure ended. Before the procedure; A music video was played 60 seconds before starting the intravenous access procedure. The Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled in by the researcher. Process order; Music video playback continued. A stopwatch was used for the procedure time. As soon as the vascular access was established, the Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were filled out again.

Behavioral: Music video listening

Buzzy+ Music video listening Group (n= 34)

EXPERIMENTAL

Before the procedure; 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.Moreover,a music video was played. 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. Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled in by the researcher.Process order; application continued. A stopwatch was used for the procedure time.When vascular access was established, the Child Fear and Anxiety and Wong-Baker Facial Expression Rating Scale were filled out again.Once the process was finished, the buzzy was removed and the music video was closed.

Behavioral: Buzzy+ Music video listening

Interventions

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.

Buzzy Group (n= 34)

Music video listening BEHAVIORAL

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

Music video listening group (n= 34)

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.

Buzzy+ Music video listening Group (n= 34)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Failure to establish vascular access on the first try

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Bircan Kahraman Berberoğlu

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

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• BIRCAN KAHRAMAN BERBEROĞLU

  Aydın Adnan Menderes Univercity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asistant

Model Details: It is a randomized controlled experimental study.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 17, 2024
• Study Start: February 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)