EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN

NCT06011668 | Completed

• 1 other identifier: SKURT-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This thesis study was conducted in an unblinded, randomized controlled experimental manner in order to analyze the effect of attention-drawing methods that can be used during intramuscular injection in children on pain and anxiety.

Conditions

Pain, Acute; Anxiety and Fear

Keywords

Pain; Anxiety; Distraction; Children; Intramuscular injection

Outcome Measures

Primary Outcomes (6)

• Pain was measured by Wong- Baker Faces Pain Scale

  The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.

  at 1st minute before the procedure

• Pain was measured by Wong- Baker Faces Pain Scale

  The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.

  during the procedure

• Pain was measured by Wong- Baker Faces Pain Scale

  The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.

  at 1st minute after the procedure

• Fear was measured by Child Fear Scale

  In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.

  at 1st minute before the procedure

• Fear was measured by Child Fear Scale

  In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.

  during the procedure

• Fear was measured by Child Fear Scale

  In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.

  at 1st minute after the procedure

Study Arms (3)

distraction method

EXPERIMENTAL

video game playing

Device: video game playing, kaleidoscope and virtual reality glasses

distraction

EXPERIMENTAL

kaleidoscope

Device: video game playing, kaleidoscope and virtual reality glasses

distraction methods

EXPERIMENTAL

virtual reality glasses

Device: video game playing, kaleidoscope and virtual reality glasses

Interventions

video game playing, kaleidoscope and virtual reality glasses DEVICE

This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.

distraction; distraction method; distraction methods

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 6-12 and their families who speak Turkish and accepted the voluntary informed consent form verbally and in writing.
• Children who do not have a chronic disease (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
• Children who have not taken an analgesic drug in the last 6 hours
• No physical or mental illness
• Children who have no suspicion of covid 19 transmission in their family or themselves
• Children whose vital signs are in parameters suitable for their age will be taken.

You may not qualify if:

• Children who did not accept the voluntary informed consent form verbally and in writing
• Children with chronic diseases (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
• Children who have taken an analgesic drug in the past 6 hours
• Those who have a suspected covid 19 transmission in their family or themselves
• Children with any physical or mental illness will not be included.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Senem Merve KURT

Mersin, Merkez, 33010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

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: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 25, 2023
• Study Start: October 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)