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The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic play group
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring pain, anxiety, Peripheral intravenous catheterisation, therapeutic play

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 3-6 year-old children, had no mental disability, were able to communicate, and had mothers volunteered to participate Exclusion Criteria: none

Sites / Locations

  • Istanbul University-Cerrahpaşa
  • Seda Caglar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic play

Control

Arm Description

The therapeutic play method with the teddy bear during PIVC was applied in this group

The standard procedure of the clinic was applied in the control group. The routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure

Outcomes

Primary Outcome Measures

Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
The FLACC Scale was used to assess the pain scores of children. The scale is scored between 0 and 10 points indicating "0": the child is relaxed and calm, "1-3": the child is mildly uncomfortable, "4-6": the child has moderate pain and "7-10": the child has severe pain.
Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
The CEMS scale was used to evaluate the anxiety scores of children.This scale, which consists of 5 different categories and 25 items, was used to evaluate the anxiety of children before and during medical procedures. Total score ranges between 5 and 25 points

Secondary Outcome Measures

Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
The STAI scale was used to assess the anxiety mean scores of the mothers.This self-assessment scale with brief statements comprises a total of 40 items, including 20 items in each of two sections, the "state anxiety inventory" and the "trait anxiety inventory". The 'State Anxiety Inventory' was designed to determine what was felt at that moment and the 'Trait Anxiety Scale' was designed to determine what was felt in the last week.

Full Information

First Posted
March 28, 2023
Last Updated
April 9, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05823324
Brief Title
The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation
Official Title
The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).
Detailed Description
The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure performed in paediatric clinics. It has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. This experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play (TP) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". In order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. Children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
pain, anxiety, Peripheral intravenous catheterisation, therapeutic play

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic play
Arm Type
Experimental
Arm Description
The therapeutic play method with the teddy bear during PIVC was applied in this group
Arm Title
Control
Arm Type
No Intervention
Arm Description
The standard procedure of the clinic was applied in the control group. The routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic play group
Intervention Description
The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention
Primary Outcome Measure Information:
Title
Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
Description
The FLACC Scale was used to assess the pain scores of children. The scale is scored between 0 and 10 points indicating "0": the child is relaxed and calm, "1-3": the child is mildly uncomfortable, "4-6": the child has moderate pain and "7-10": the child has severe pain.
Time Frame
data collected just before and within 5 min after peripheral intravenous catheterization procedure
Title
Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
Description
The CEMS scale was used to evaluate the anxiety scores of children.This scale, which consists of 5 different categories and 25 items, was used to evaluate the anxiety of children before and during medical procedures. Total score ranges between 5 and 25 points
Time Frame
data collected just before and within 5 min after peripheral intravenous catheterization procedure
Secondary Outcome Measure Information:
Title
Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
Description
The STAI scale was used to assess the anxiety mean scores of the mothers.This self-assessment scale with brief statements comprises a total of 40 items, including 20 items in each of two sections, the "state anxiety inventory" and the "trait anxiety inventory". The 'State Anxiety Inventory' was designed to determine what was felt at that moment and the 'Trait Anxiety Scale' was designed to determine what was felt in the last week.
Time Frame
data collected just before and within 5 min after peripheral intravenous catheterization procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 3-6 year-old children, had no mental disability, were able to communicate, and had mothers volunteered to participate Exclusion Criteria: none
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey
Facility Name
Seda Caglar
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

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