Procedural Pain Clinical Trial
Official title:
The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)
Verified date | June 2020 |
Source | Istanbul Medeniyet University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | August 14, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medeniyet University | Istanbul | Kadiköy |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medeniyet University |
Turkey,
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).
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
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.
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over. | Through painful procedure completion, an average of 10 minutes | |
Primary | Wong-Baker FACES Pain Rating Scale (WB-FACES) | The WB-FACES was developed by Wong and Baker in 1981 and revised in 1983. The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right (0 = very happy/no pain, 5 = the worst pain imaginable). The first face is a happy face representing "no pain" (0) while the last face is a crying face representing "the worst pain imaginable" (5). Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain. | Through painful procedure completion, an average of 10 minutes | |
Primary | Children's Fear Scale (CFS) | The CFS was developed by McMurtry et al. (2011) to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral (0) to extreme fear (4). Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures | Through painful procedure completion, an average of 10 minutes |
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