Nonpharmacological Methods for Children in Procedural Pain

NCT04421430 | Completed DMC

• 1 other identifier: 2017-10/9
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Procedural Anxiety

Keywords

Anxiety; Children; Nursing; Acute pain management

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

Distraction cards group

EXPERIMENTAL

Distraction cards was applied to the children in this group during the venipuncture procedure.

Other: Distraction cards

Virtual reality group

EXPERIMENTAL

Virtual reality intervention was applied to the children in this group during the venipuncture procedure.

Other: Virtual reality

Buzzy® group

EXPERIMENTAL

Buzzy® was applied to the children in this group during the venipuncture procedure.

Other: Buzzy

Control group

NO INTERVENTION

The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.

Interventions

Distraction cards OTHER

The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully. During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them. Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture. The distraction cards intervention and venipuncture were terminated at the same time.

Also known as: Flippits1, MMJ Labs, Atlanta, Georgia, ABD

Distraction cards group

Virtual reality OTHER

The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure. The virtual reality intervention and venipuncture were terminated at the same time.

Virtual reality group

Buzzy OTHER

Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults. Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure. After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure. Buzzy® was on throughout the procedure. The Buzzy® intervention and venipuncture were terminated at the same time.

Buzzy® group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (5)

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

  PMID: 3344163 BACKGROUND

• 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.

  PMID: 21806301 BACKGROUND

• 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.

  PMID: 33485746 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Aynur Aytekin Ozdemir, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: November 16, 2017
• Primary Completion: May 31, 2018
• Study Completion: August 14, 2018
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)