Clinical trial NCT06011668: EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN
Official title: THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety and Fear
Keywords: Pain
Anxiety
Distraction
Children
Intramuscular injection
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain was measured by Wong- Baker Faces Pain Scale
timeFrame: at 1st minute before the procedure
measure: Pain was measured by Wong- Baker Faces Pain Scale
timeFrame: during the procedure
measure: Pain was measured by Wong- Baker Faces Pain Scale
timeFrame: at 1st minute after the procedure
measure: Fear was measured by Child Fear Scale
timeFrame: at 1st minute before the procedure
measure: Fear was measured by Child Fear Scale
timeFrame: during the procedure
measure: Fear was measured by Child Fear Scale
timeFrame: at 1st minute after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Senem Merve KURT
state: Merkez
Study officials:
References: