NCT05790005

Brief Summary

The goal of this experimental study is to determine the effect of therapeutic play method applied to hospitalized children aged 7-12 before the first surgical dressing attempt, on anxiety and fear. Researcher will compare the study and control groups to see if therapeutic play has an effect on anxiety and fear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2023

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 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 23, 2023

Last Update Submit

February 10, 2024

Conditions

Keywords

AnxietyFearHospitalized ChildDressingsPlayOperation

Outcome Measures

Primary Outcomes (6)

  • Child Anxiety Scale-State Scale

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

    two hours before the surgical dressing

  • Child Anxiety Scale-State Scale

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

    fifteen minutes before the surgical dressing

  • Child Anxiety Scale-State Scale

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

    immediately after the surgical dressing

  • Child fear scale

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

    two hours before the surgical dressing

  • Child fear scale

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

    fifteen minutes before the surgical dressing

  • Child fear scale

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

    immediately after the surgical dressing

Study Arms (2)

Intervention group

EXPERIMENTAL

A therapeutic play will be played for 20 minutes after the warm-up play for 10 minutes before the first surgical dressing to be applied after the surgery with children in the 7-12 age groups. There will be 46 children in the intervention group.

Other: therapeutic play

Control group

NO INTERVENTION

Therapeutic play will be not played for 20 minutes after the 10-minute warm-up game before the first surgical dressing to be applied after the surgery with children in the 7-12 age group. The routine procedure applied in the service before the dressing process will be applied. There will be 46 children in the control group.

Interventions

2 days after the operation, 1 hour before the dressing, a warm-up game will be played with the child in the playroom of the pediatric surgery service, aiming to put the organs prepared by the researcher in their correct places on the picture for the first 10 minutes. Then, the teddy bear, which is given the appearance of an operation area by sewing a zipper on his stomach, will be given to the child and he will be asked to make the first dressing of the teddy bear. therapeutic game, in which the dramatization method is used, will last 20 minutes. During the 30-minute play practice, the child's questions will be answered.

Intervention group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children in the 7-12 age group
  • Children who speak and understand Turkish
  • Children whose first dressing will be done in the service on the second day after the operation

You may not qualify if:

  • Children with hearing, vision and speech problems in themselves or their parents
  • Children with a mental disorder in themselves or in their parents
  • Children who had circumcision surgery (because the primary dressing was removed and crystallin spray was sprayed on the surgical area and the area was left open)
  • Children who should not move before dressing (having hypospadias surgery)
  • Children still in the intensive care unit at the time of the first surgical dressing
  • Children whose dressing had to be changed before the second postoperative day (wetting, bleeding, opening, etc.)
  • Children with previous play therapy experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celal Bayar University Hafsa Sultan Hospital

Manisa, Uncubozköy, 45010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hüsniye Çalışır, Prof. Dr.

    Aydin Adnan Menderes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups, the Intervention group and the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 29, 2023

Study Start

April 7, 2023

Primary Completion

September 15, 2023

Study Completion

December 27, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations