Nonpharmacological Methods for Children

Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of the methods of cold application and Shotblocker on the pain and anxiety level of the children in reducing the pain associated with the intramuscular injection.

The hypotheses of the study:

Hypothesis 0. Shotblocker and the cold application to the injection site prior to the injection are not effective in reducing the pain associated with the intramuscular injection in children.

Hypothesis 1. Using ShotBlocker during the intramuscular injection reduces the pain and anxiety experienced by the child.

Hypothesis 2. Applying cold to the injection site prior to the intramuscular injection reduces the pain and anxiety experienced by the child.

This research was designed as a randomized controlled experimental study in a university hospital in Çorum.

The sample of the study comprised 150 children aged 7 to 12 years who were brought to the pediatric injection room in a university hospital and had intramuscular injection. The children were randomized into the Shotblocker (n=50), cold application (n=50) and control (n=50) groups. In addition to Wong-Baker Pain Scale and Child Anxiety Scale, the Child Information Form was used in the study to determine the introductory characteristics of the children and their family.

Conditions

• Child
• Procedural Anxiety
• Procedural Pain

Interventions

OTHER

Cold application group

Cold application group (Group 1): In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.

OTHER

Shotblocker group

Shotblocker group (Group 2): The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.

OTHER

Control Group

Control Group (Group 3): The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.

Sponsors & Collaborators

• Bandırma Onyedi Eylül University

  lead OTHER

Principal Investigators

• Selen OZAKAR AKÇA, PhD, RN, Associate Professor · Hitit University

• Havva Nur PELTEK KENDİRCİ, PhD, MD, Associate Professor · Hitit University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2018-06-30

Completion

2018-12-20

Countries

• Turkey (Türkiye)

Study Locations