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

Sponsor

Mersin University (Other)

Overall Status

Completed

CT.gov ID

NCT06011668

Collaborator

(none)

180

Enrollment

Location

Arms

Actual Duration (Months)

89.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Anxiety and Fear	Device: video game playing, kaleidoscope and virtual reality glasses	N/A

Detailed Description

Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and Research Hospital between October and December 2021. Children aged 6-12 years were included in the study. In the study, the sample was divided into four groups. The study consisted of 180 children, 45 children in each group. Using the randomization program, it was determined which sample group the children would be included in.

In the study, video game playing, kaleidoscope and virtual reality glasses were used as a distraction method for the experimental group. Intramuscular injection (IM) was applied to the control group without any application. The research implementation period lasted an average of one minute. Required ethical permissions were obtained prior to the research. Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale (CFS) was used to measure anxiety level in the study. Explanatory information about the application to be made to the children and their parents was given by the researcher, and the consent form was signed by informing them voluntarily. The research data were collected by the researcher by interviewing the children face to face. In line with the data obtained in the study, it was concluded that the descriptive characteristics of the children in the experimental and control groups were similar (p>0.05). It was concluded that playing video games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in the study, reduced pain and anxiety. It is expected that techniques that reduce pain and anxiety when intramuscular injections are given to children in nursing practices will be used in practice and that these practices will be included in the training of nurses.

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS

Actual Study Start Date :

Oct 15, 2021

Actual Primary Completion Date :

Oct 15, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: distraction method video game playing	Device: video game playing, kaleidoscope and virtual reality glasses 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.
Experimental: distraction kaleidoscope	Device: video game playing, kaleidoscope and virtual reality glasses 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.
Experimental: distraction methods virtual reality glasses	Device: video game playing, kaleidoscope and virtual reality glasses 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.

Arm

Intervention/Treatment

Experimental: distraction method

video game playing

Device: video game playing, kaleidoscope and virtual reality glasses

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.

Experimental: distraction

kaleidoscope

Device: video game playing, kaleidoscope and virtual reality glasses

Experimental: distraction methods

virtual reality glasses

Device: video game playing, kaleidoscope and virtual reality glasses

Outcome Measures

Primary Outcome Measures

Pain was measured by Wong- Baker Faces Pain Scale [at 1st minute before the procedure]
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.
Pain was measured by Wong- Baker Faces Pain Scale [during the procedure]
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.
Pain was measured by Wong- Baker Faces Pain Scale [at 1st minute after the procedure]
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.
Fear was measured by Child Fear Scale [at 1st minute before the procedure]
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.
Fear was measured by Child Fear Scale [during the procedure]
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.
Fear was measured by Child Fear Scale [at 1st minute after the procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.