Nonpharmacological Methods for Children in Procedural Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2018-08-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Procedural Pain Procedural Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Distraction cards group

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

Group Type EXPERIMENTAL

Distraction cards

Intervention Type 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.

Virtual reality group

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

Group Type EXPERIMENTAL

Virtual reality

Intervention Type 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.

Buzzy® group

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

Group Type EXPERIMENTAL

Buzzy

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Distraction cards

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.

Intervention Type OTHER

Virtual reality

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.

Intervention Type OTHER

Buzzy

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.

Intervention Type OTHER

Other Intervention Names

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Flippits1, MMJ Labs, Atlanta, Georgia, ABD

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes