Procedural Pain Clinical Trial
Official title:
The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility | 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 unit 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Yalova | Yalova |
Lead Sponsor | Collaborator |
---|---|
University of Yalova |
Turkey,
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: 10.10 — View 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. — View 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 2 — View 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. — View 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 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES | The Wong-Baker Faces Pain Scale revised (W-BFS) is used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of "0" to "10." Pain is described by selecting the facial expression depicting the degree of perceived pain. This scale will be assessed independently by the child, a parent who is present and observes the child's behavior, and the same nurse who is independent of the study. | Pain levels of the children will be evaluated 1 minute after the procedure. | |
Primary | Comparison of the fear score values of the groups | The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure. | Children's fear levels will be evaluated first 1 minutes before the procedure. | |
Primary | Comparison of the fear score values of the groups | The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure. | Children's fear levels will be evaluated 1 minutes after the procedure. |
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