Clinical trial NCT04421430: Nonpharmacological Methods for Children in Procedural Pain
Official title: The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Procedural Anxiety
Keywords: Anxiety
Children
Nursing
Acute pain management
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized into the experimental and control groups using a block randomization method. Literature shows that age, gender, and fear are three factors affecting procedural pain and anxiety in children (Ball, Bindler, \& Cowen, 2010; Twycross, 2009). Therefore, the variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization. The blocks were repeated five times in each group (2X2X2X5), and 40 participants were assigned to each. The sealed envelope method was used to randomly assign participants to the groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.

Detailed description: The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and Buzzy®, can be used especially in acute settings.

Eligibility criteria: Inclusion Criteria:

* Due to undergo venipuncture for blood testing
* Suitable for venipuncture at antecubital location using a 21 Gauge X 1.5 inch needle
* Due to undergo venipuncture under the same environmental conditions (phlebotomy seat, heat, light, noise, etc.)
* Due to undergo venipuncture at the first attempt

Exclusion Criteria:

Children;

* had chronic diseases
* had neuro-developmentally delayed
* had visual, audio, or speech impairments
* were hospital stay for treatment
* had a history of sedative, analgesic or narcotic use within 24 hours before admission

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Through painful procedure completion, an average of 10 minutes
measure: Wong-Baker FACES Pain Rating Scale (WB-FACES)
timeFrame: Through painful procedure completion, an average of 10 minutes
measure: Children's Fear Scale (CFS)
timeFrame: Through painful procedure completion, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Ozdemir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball, J. W., Bindler, R. C., &Cowen, K. J. (2010). Child Health Nursing: Partnering withak Children and Families. (2 th ed.) London: Pearson Education (Chapter 2).
citation: Twycross A. (2009). Managing pain in children. In: Dowden, S. J., & Bruce, E., (eds.). A Clinical Guide (pp. 42-49). New Jersey: Blackwell Publishing Ltd.
citation: Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
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: Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.