Clinical trial NCT06443437: Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy
Official title: Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy Among Preschool Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fear of Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.

Detailed description: Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .

Eligibility criteria: Inclusion Criteria:

1. children and parents who agreed to participate in the study
2. children had successful phlebotomy in the first attempt.

Exclusion Criteria:

1. Children who are having a chronic disease
2. Mental disability or mental retardation
3. Taking analgesics in the last 24 hours
4. Undergone a surgical procedure,
5. Not having a successful phlebotomy on the first attempt,
6. The child and his/her family not being willing to participate in the study.

Primary outcomes:
measure: child pain
timeFrame: during phlebotomy
Secondary outcomes:
measure: child fear
timeFrame: during phlebotomy
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university children hospital
Study officials:
affiliation: Assiut university faculty of nursing
name: Safaa R Osman, post doctor
role: STUDY_CHAIR
affiliation: Assiut university faculty of nursing
name: . Nahed T Mohamed, post doctor
role: STUDY_CHAIR
affiliation: Assiut university faculty of nursing
name: Amira H Abdelfatah, post doctor
role: STUDY_DIRECTOR
References:
citation: Yildirim BG, Gerceker GO. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2023 Jan;49(1):62-74. doi: 10.1016/j.jen.2022.09.018. Epub 2022 Nov 12.
citation: Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.
citation: Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.
citation: Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.
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: Kuo HC, Pan HH, Creedy DK, Tsao Y. Distraction-Based Interventions for Children Undergoing Venipuncture Procedures: A Randomized Controlled Study. Clin Nurs Res. 2018 May;27(4):467-482. doi: 10.1177/1054773816686262. Epub 2016 Dec 30.