Clinical trial NCT03915704: Intramuscular Injection-Related Pain and Fear
Official title: Effects of Two Different Methods During Intramuscular Injections On Pain, Fear, and Satisfaction in Pediatric Emergency Department Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Keywords: pain management
intramuscular injection
non-pharmacological method
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is an experimental randomized controlled study conducted to compare the effect of buzzy and shotblocker methods applied during intramuscular injection from on pain and fear level in 6-12 year-old children. The sample of the study consisted of 90 children aged between 6 and 12 years who were diagnosed with upper and lower tract respiratory infections and received intramuscular injection of ceftriaxone at the pediatric emergency department of a university hospital in İstanbul between November 2018 and April 2019. The children were divided into 3 groups of 30 people, including shotblocker, buzzy, and control groups. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.

Detailed description: The study is a randomized controlled, non-blinded, experimental trial. The sample of the study consisted of 90 children aged between 6 and 12 years who were diagnosed with upper and lower tract respiratory infections and received intramuscular injection of ceftriaxone at the pediatric emergency department of a university hospital in İstanbul between November 2018 and April 2019. The children were recruited into the study on the basis of the following criteria: being aged between 6-12, requiring for ceftriaxone intramuscular injection because of upper and lower respiratory tract infections, being cognitively able to rate pain and fear scales, and voluntariliy signing the written informed consent. Children were excluded if they had a disease causing chronic pain, received analgesics within the last 6 hours, with pacemakers, had infection, rash, or detoriorated skin integrity in the site where the injection was to be made, had nerve damage in the injection site, had critical or unstable health status, had intellectual disability, reynaud's syndrome, and sickle cell disease, and were unwilling to participate in the study. Also, the parents were eligible for the participation when meeting the following inclusion criteria: 1) be healthy in terms of neurologic functions, 2) communicate verbally, 3) understand and read Turkish, and 4) voluntarily sign the written informed consent. The sample size should be determined as minimum 30 in both experimental and control groups in the experimental studies and parametric measurements. Therefore, 90 children who met the inclusion criteria of the study between specified dates were enrolled and each group included 30 children including two experimental groups and a control group. In order to prevent bias and increase the validity of the data, the pain and fear scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:90), their parents (n:90), and a researcher specialized in pediatric nursing (n:1).

The children were included in one of the 3 study groups, including buzzy, shotblocker, and control group without any intervention. In order to control the effect of gender on pain, the children were stratified into study groups based on their gender and selected by using block randomization methods in three study groups. The children were randomized to the related study group by drawing one of the study groups in the cloth bags prepared for the girls (pink) and the boys (blue). Papers with the same color and folding pattern representing the four groups (1,2,3,4) were thrown in the bags. In order to provide a randomized distribution and to reduce all negative effects, the children were asked to take randomly a paper from the bag according to the gender after making the necessary explanation to the parents and their children so that the groups became self-balancing. A total of 30 children including 15 girls and 15 boys were included in each group after intervention and control groups were matched in themselves in terms of gender.

The study followed the CONSORT guideline for reporting randomized controlled trials. The pain level of children before and after the injection was assessed using Wong-Baker FACES Pain Rating Scale. To assess the pain level of the children, the children were asked to evaluate themselves, and their parents and first researcher were requested to evaluate the children's pain level immediately before and after the injection. The responses of the children, their parents, and the first researcher were scored blindly. The fear level of children before and after the injection was assessed using Children's Fear Scale. To assess the fear level of the children, the children were asked to evaluate themselves, and their parents and first researcher were requested to evaluate the children's fear level immediately before and after the injection. The responses of the children, their parents, and the first researcher were scored blindly.

Eligibility criteria: Inclusion Criteria:

1. being aged between 6-12,
2. requiring for ceftriaxone intramuscular injection because of upper and lower respiratory tract infections,
3. being cognitively able to rate pain and fear scales, and voluntariliy signing the written informed consent.

Exclusion Criteria:

1. having a disease causing chronic pain,
2. receiving analgesics within the last 6 hours, with pacemakers,
3. having infection, rash, or detoriorated skin integrity in the site where the injection was to be made, had nerve damage in the injection site,
4. having critical or unstable health status, had intellectual disability, reynaud's syndrome, and sickle cell disease
5. being unwilling to participate in the study.

Primary outcomes:
measure: Pain severity
timeFrame: 5 Months
Secondary outcomes:
measure: Fear Levels
timeFrame: 5 Months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Saglik Bilimleri University
Study officials:
affiliation: Saglik Bilimleri University
name: Burcu Aykanat Girgin, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: