NCT05288309

Brief Summary

Medical procedures are negative experiences that cause pain, distress, and anxiety and are not only uncomfortable during medical procedures, especially in children; negative consequences such as poor recovery, sleep disturbances, and post-traumatic stress symptoms. There are many different approaches, including pharmacological and non-pharmacological methods, for the treatment of pain and anxiety in children during medical procedures. Non-pharmacological methods vary depending on the child's age, level of development and the type of procedure, and non-pharmacological methods generally used in children fall into three groups: supportive, physical and cognitive or behavioral methods. Supportive methods are practices that include psychosocial care of the child, such as reading a book or playing games. Physical methods include techniques such as cold application, massage, and transcutaneous electrical nerve stimulation. Cognitive or behavioral methods include practices such as listening to music, daydreaming, relaxation, and various methods of distraction. Cognitive and behavioral approaches typically use the activating or relaxing effects of music for arousal or calming and to enhance the learning of certain skills and behaviors. Music therapy practice reduces pain and anxiety levels by stimulating the pituitary gland. Another method used is the use of kaleidoscope. In the literature, they reported that the use of kaleidoscope is effective in reducing the pain that may occur during blood collection in studies conducted with preschool and school children, children and adolescents, and school-age children. The results show that the kaleidoscope can be used effectively to distract children from the painful procedure and reduce the perception of pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

February 3, 2022

Last Update Submit

October 19, 2022

Conditions

Keywords

AnxietyBlood drawchildrenNursingPainRainstickKaleidoscope

Outcome Measures

Primary Outcomes (1)

  • Comparison of Wong-Baker Faces Pain Scale Mean Scores by Groups

    This scale measuring the severity of pain was used in children aged between 3-18 years. In this scale, pain was scored for facial expressions according to numerical values, and the numerical rating of the scale varied between 0 and 10. Facial expressions ranging from smiling (0=very happy/no pain) to crying (10=most painful) indicated emotions.

    It will be evaluated within an average of 5 minutes during the blood collection process.

Secondary Outcomes (1)

  • Comparison of Child Anxiety Scale Mean Scores before and during the procedure according to the groups

    It will be evaluated within an average of 3 minutes before the blood draw and an average of 3 minutes during the blood collection process.

Study Arms (2)

RAİNSTİCK

OTHER

In the 1st experimental group, the sound of the rain stick was played to distract attention. The rainstick, used by traditional societies, is a rhythm instrument that makes the sound of rain by moving it up and down. The length of the rain stick made of bamboo is 40 cm. There are spiral-shaped spines inside the tool, which is closed at both ends. It makes the sound of drizzling rain by moving it up and down.

Other: RAINSTİCK

KALEİDOSCOPE

OTHER

In the second experimental group, kaleidoscope was used to distract attention. A kaleidoscope, or kaleidoscope, is a device that sees colorful patterns when looked into. Inside, there are three mirrors adjacent to each other with an inclination of 60 degrees between them. There are pieces of colored glass between the mirrors. When viewed from one end of this binocular, shape-shifting polygons are seen, often with images that will never be the same again. These patterns are created by the reflection of light and change constantly as the binoculars are moved.

Other: KALEİDOSCOPE

Interventions

When the child, who was taken to Experimental Group 1, sat on the patient's chair, the sound of the rain stick was started to be played 1 minute before the blood draw. At that time, the nurse began to prepare the child for the blood draw. The tourniquet insertion procedure and the determination of the vein from which blood will be drawn from the antecubital region were performed by the nurse. Blood collection was taken from the antecubital region in one go by the same nurse by means of a vacuum blood collection tube, and blood flowed to the vacuum within 5 seconds, showing that the procedure was successful. This process took about 2-3 minutes and the children listened to the sound of rain sticks throughout the process.

RAİNSTİCK

The child, who was taken into Experimental Group 2, was started to watch the kaleidoscope 1 minute before the blood draw, as he sat on the patient's chair. At that time, the nurse began to prepare the child for the blood draw. The tourniquet insertion procedure and the determination of the vein from which blood will be drawn from the antecubital region were performed by the nurse. Blood collection was taken from the antecubital region in one go by the same nurse by means of a vacuum blood collection tube, and blood flow to the vacuum within 5 seconds showed that the procedure was successful. This process took about 2-3 minutes and children were watched with kaleidoscope throughout the process.

KALEİDOSCOPE

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must be between 5-12 years old
  • There should be no pain before the blood draw procedure
  • Should not have a chronic disease that will cause pain Blood should be taken from the antecubital region
  • Must be willing to participate in the research

You may not qualify if:

  • The transmission barrier
  • Wearing glasses
  • Involuntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erzincan Binali Yıldırım University

Merkez, Erzi̇ncan, 24000, Turkey (Türkiye)

Location

Erzincan Binali Yıldırım Üniversitesi

Merkez, Erzi̇ncan, 24000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersPain, Procedural

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Children in the 5-12 age group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 21, 2022

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 10, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations