The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

NCT05823324 | Completed DMC

• 1 other identifier: SeCaglar
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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).

Conditions

Pain; Anxiety

Keywords

pain; anxiety; Peripheral intravenous catheterisation; therapeutic play

Outcome Measures

Primary Outcomes (2)

• 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.

  data collected just before and within 5 min after peripheral intravenous catheterization procedure

• 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

  data collected just before and within 5 min after peripheral intravenous catheterization procedure

Secondary Outcomes (1)

• Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization

  data collected just before and within 5 min after peripheral intravenous catheterization procedure

Study Arms (2)

Therapeutic play

EXPERIMENTAL

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

Behavioral: Therapeutic play group

Control

NO INTERVENTION

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

Interventions

Therapeutic play group BEHAVIORAL

The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention

Therapeutic play

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year-old children,
• had no mental disability,
• were able to communicate,
• and had mothers volunteered to participate

You may not qualify if:

• none

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpaşa

Istanbul, 34381, Turkey (Türkiye)

Location

Seda Caglar

Istanbul, 34381, Turkey (Türkiye)

Location

Related Publications (1)

• Anderoglu S, Caglar S. The effect of therapeutic play with teddy bear on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation: a randomised clinical trial. BMC Pediatr. 2025 Dec 6;26(1):29. doi: 10.1186/s12887-025-05769-4.

  PMID: 41351041 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 21, 2023
• Study Start: February 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)