Clinical trial NCT05823324: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: pain
anxiety
Peripheral intravenous catheterisation
therapeutic play
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
timeFrame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
measure: Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
timeFrame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
Secondary outcomes:
measure: Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
timeFrame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
city: Istanbul
country: Turkey
facility: Seda Caglar
Study officials:
References: