The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

NCT ID: NCT05823324

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-06-01

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

Conditions

Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Therapeutic play

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

Group Type: EXPERIMENTAL

Therapeutic play group

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapeutic play group

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Seda Caglar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Seda Caglar

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SeCaglar

Identifier Type: -

Identifier Source: org_study_id