Skip to main content
OpenTrials
Completed

NCT Number: NCT06262984

Therapeutic Play Before Nasopharyngeal Swabbing in Children

The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maltepe University

Istanbul, Turkey (Türkiye)

About this study

Many different non-pharmacological methods are used to cope with negative emotional responses such as pain, stress, fear and anxiety caused by diagnostic procedures in children. One of these non-pharmacological methods is therapeutic play. Therapeutic play method applied in line with the philosophy of atraumatic care in preparation for medical diagnostic procedures can ensure children's adaptation to the procedures by reducing the negative emotional effects of these procedures on the child. Energy Expenditure Play, Dramatic Play and Creative Play are used as therapeutic play types.

The aim of this study is to determine the effect of therapeutic play applied before the nasopharyngeal swab procedure on the emotional indicators of children aged 3-6 years who apply to the pediatric clinic and pediatric service. In line with the results obtained from studies using a similar research method, the sample size of the study was determined by power analysis (G*Power 3.1.9.4). The sample size was found to be 68 children in total, with a minimum of 34 children for each group. To collect data, an information form and the Children's Emotional Manifestation Scale (CEMS) will be used. Children and their parents who apply to the pediatric service and pediatric outpatient clinic will be informed about the study. The children and parents included in the study will be informed about the research by the researcher through a face-to-face meeting, and a consent form and information form will be filled out. Children will determine their groups by drawing lots. The researcher will demonstrate the nasopharyngeal swabbing process on the doll with the children who have chosen a therapeutic play group, using a therapeutic play method, and play with the child. Children who choose the control group will be explained the nasopharyngeal swab procedure as routinely performed in the outpatient clinic. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between the ages of 3 and 6,
  • Children who have not received medical attention in the last 24 hours,
  • Children without speech, hearing, psychological or neurological problems,
  • Children who can speak and understand Turkish at native level,
  • Children and their parents who agree to participate in the research.

Exclusion criteria

  • Being younger than 3 years old and older than 6 years old,
  • Children who received medical intervention in the last 24 hours,
  • Children with any speech, hearing, psychological or neurological problems,
  • Children who do not speak Turkish as their native language,
  • Children and their parents who do not agree to participate in the research.

Treatment and study plan

Therapeutic Play

Other

The researcher will demonstrate the nasopharyngeal swabbing process on the doll with the children who have chosen a therapeutic play group, using a therapeutic play method, and play with the child. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

Primary outcomes

  1. Children's emotional manifestation

    Time frame: one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing

    The child's emotional response will be evaluated with the Children's Emotional Manifestation Scale (CEMS) by the researcher and the observing nurse before, during and after the procedure.

    In the scale, emotional indicators are evaluated according to 5 parameters (facial expression, voice, activity, interaction, cooperation level). These five parameters are scored from 1 to 5, with the lowest score being '5' and the highest being '25'. A higher scale score indicates that the child showed more negative emotional behavior during the procedure.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

The Effect of the Therapeutic Play Applied Before Nasopharyngeal Swaping on Children's Emotional Manifestation in the 3-6 Years Old Group

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.