NCT05320614

Brief Summary

This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep. This study is a randomized controlled experimental study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

March 4, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

March 4, 2022

Last Update Submit

January 9, 2025

Conditions

Keywords

Web-based education,therapeutic playanxietypainfear

Outcome Measures

Primary Outcomes (1)

  • Child Fear Scale:

    This scale is scored between 0-4 based on five different facial expressions, a higher scale score indicates more fear.

    On the day of the operation, one hour before the operation, the child is asked to rate his/her fear according to this scale.

Secondary Outcomes (1)

  • Yale Modified Preoperative Anxiety Scale Child Form

    An evaluation is made by the researcher 30 minutes before the operation and when the anesthesia mask is shown in the operating room.

Other Outcomes (2)

  • Wong-Baker Facial Pain Scale

    An evaluation is made by asking the child to rate his/her pain according to this scale, two hours after he/she comes to the service room after the surgery and before being discharged.

  • Sleep Disturbance Scale For Children

    It is filled ten days after the operation. When the child comes to the check-up ten days after discharge from the hospital, the evaluation is completed by the parent in the polyclinic.

Study Arms (2)

case 1

EXPERIMENTAL

Case Group:Web-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery

Other: Web-Based Education

control 1

EXPERIMENTAL

Control Group: Explaining the routine care given in the service by the pediatric surgery nurse to the child and parent in the control group.

Other: Routine maintenance Training

Interventions

Web-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery

case 1

Explaining the routine care given to the child and parent in the control group by the pediatric surgery nurse in the service.

control 1

Eligibility Criteria

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

You may qualify if:

  • Agreeing to participate in the research,
  • Those who will have a planned surgery between the ages of 7-12,
  • Having and able to use a computer/tablet and internet connection at home,
  • Having the ability to use a computer / tablet,
  • Pediatric patients given written consent by their parents

You may not qualify if:

  • At least one previous experience of surgery
  • Having communication problems (sight, hearing, mental),
  • Diagnosed with anxiety disorder,
  • Genetic/congenital disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MSKU

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Derya DEMİR UYSAL

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hüsniye ÇALIŞIR, Prof.Dr

    Aydin Adnan Menderes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 11, 2022

Study Start

March 10, 2022

Primary Completion

April 24, 2023

Study Completion

December 20, 2023

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations