NCT06262984

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

23 days

First QC Date

February 8, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

ChildNasopharyngeal swabTherapeutic playEmotional manifestation

Outcome Measures

Primary Outcomes (1)

  • Children's emotional manifestation

    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.

    one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing

Study Arms (2)

Therapeutic Play Group

EXPERIMENTAL

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.

Other: Therapeutic Play

Control Group

NO INTERVENTION

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.

Interventions

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.

Therapeutic Play Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Interventions

Play Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Zeynep Erkut, PhD

    Maltepe University

    PRINCIPAL INVESTIGATOR
  • Melisa Şengül

    Acıbadem Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

February 19, 2024

Primary Completion

March 13, 2024

Study Completion

March 13, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations