Clinical trial NCT06354608: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children
Official title: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Procedural Pain
Keywords: Audio Book
Vibration
Intramuscular Injection
pediatric emergency
Child
pain
fear
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental, parallel-group (intervention-control), randomized controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.

Detailed description: IM injection is one of the medical procedures that causes pain and fear in children. It has been reported that the effect of children's previous pain and fearful experiences continues into adulthood, and this may lead to the avoidance of subsequent medical procedures as a reaction to increased pain and fear. For all these reasons, pediatric nurses and other healthcare professionals should aim for successful pain control before and during painful procedures in children to prevent future adverse effects of painful medical procedures.

Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children. Therefore, all healthcare professionals, especially nurses, as the first person to welcome children into the hospital and the person who spends the most time with the child, have important responsibilities in eliminating children's fear of medical procedures. It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure. It is known that non-pharmacological pain control methods help the child cope with pain, reduce pain, and alleviate distress from invasive procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. These include relaxation techniques, deep breathing, listening to music, singing and talking, watching cartoons, games, vibration and cold applications, and distraction cards. As understood from the studies, nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain.

It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques. When the literature was reviewed, it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients, whereas there were a limited number of studies evaluating the methods independently. It is thought that there is a need for planning randomized controlled experimental nursing studies in this field. This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years. While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024, the sample consisted of 120 children who met the sample selection criteria. The research consists of 3 groups. These groups will audio book group (n=40), local vibration group (n=40), and control group (n=40). In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com, Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain and fear score. The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Children's Fear Scale (CFS).

Eligibility criteria: Inclusion Criteria:

* The child and family agree to participate in the research,
* The child is between the ages of 4-6,
* The child does not have a chronic and mental health problem,
* Absence of visual, auditory problems or mental retardation at a level that can fill the scales,
* No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
* Absence of a disease causing chronic pain,
* Not having a febrile illness at the time of application,
* Being treated in the pediatric emergency unıt at the time of the study,
* Intramuscular injection in the vastus lateralis region,
* Ondansetron will be injected intramuscularly in the vastus lateralis area, as directed by the doctor.
* Performing the operation at once.

Exclusion Criteria:

* The child and family's refusal to participate in the research,
* Having a visual and auditory problem
* The child is less than 4 years old or older than 6 years old
* The child has a chronic and mental health problem
* The child experiences pain,
* To have taken analgesic medication in the last 6 hours.

Primary outcomes:
measure: Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES
timeFrame: Pain levels of the children will be evaluated 1 minute after the procedure.
measure: Comparison of the fear score values of the groups
timeFrame: Children's fear levels will be evaluated first 1 minutes before the procedure.
measure: Comparison of the fear score values of the groups
timeFrame: Children's fear levels will be evaluated 1 minutes after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: University of Yalova
Study officials:
affiliation: Director
name: Duygu Demir, Assis. Prof.
role: STUDY_DIRECTOR
affiliation: Researcher
name: Derya Kılıç, Assis. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
citation: Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
citation: Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
citation: Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy(R) and ShotBlocker(R) during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.
citation: Sunitha Suresh BS, De Oliveira GS Jr, Suresh S. The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial. Pediatr Surg Int. 2015 Feb;31(2):197-201. doi: 10.1007/s00383-014-3649-9. Epub 2015 Jan 3.