Clinical trial NCT02832050: PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)
Official title: PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Anxiety
Rheumatology
Keywords: play
therapy
Lead sponsor: Alder Hey Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study synopsis Objectives

* To determine whether delivering a semi-structured play therapy intervention can improve procedure-related anxiety / ability to cope with a procedure / procedure-related pain for children and young people.
* To determine whether delivering a semi-structured play therapy intervention can improve patient experience of blood monitoring.

Patients

* Patients aged 5 - 17 years who are under the care of the rheumatology team.
* Patients expected to require at least two blood tests during a 12 week period. Design
* Recruitment over 24 weeks with each child in the study for a 12 week period.
* 20 patients will receive play therapy intervention as outlined in the play therapy intervention for blood tests.
* 20 patients will be the comparator group. They will be offered standard care for blood tests.
* All children will be offered local anaesthetic cream for each blood test. Blood tests will be performed by venepuncture unless specifically requested otherwise by patient.
* All children will complete outcome measures at baseline, beginning and end of each procedure session and at completion of the study at 16 weeks.

Outcome Measures

* Procedure-related anxiety visual analogue scale (VAS) score - completed by child
* Observer procedure-related anxiety VAS score - completed by parent
* Procedure-related coping VAS score - completed by child
* Procedure-related pain VAS score - completed by child
* Patient experience VAS score - completed by child and parent separately

Detailed description: Children and young people experience significant pain and distress related to procedures. There are many studies looking at psychological and pharmacological interventions demonstrating that these can reduce procedural-related pain and distress. Distraction is frequently studied and consistently demonstrated to reduce procedure-related pain and in some cases distress. It has also been shown that children choose different distractors, and this can be related to age and sex. Best practice for distraction should therefore include identifying and working with individual patient preferences and this can additionally help by giving children some control over the procedure. There are limited studies looking at other interventions such as preparation and parent positioning showing that these interventions can have a positive impact on distress and coping. Few trials examine effect of interventions over time and multiple procedures.

Play specialists provide therapeutic play for children undergoing procedures. They use a combination of psychological interventions alongside pharmacological interventions which includes preparation for the procedure, support during the procedure and post-procedure. However, whilst there is information about what play therapy should involve and which standards should be met, we are unaware of any specific framework of how this should be delivered.

Investigators have developed a semi-structured play therapy intervention, which is developed from standard play therapy theory and well-recognised techniques as well as expert experience. This play therapy intervention is designed to represent a gold standard of care for delivering play therapy to children requiring procedures. The intervention aims to deliver play therapy in a standardised fashion whilst utilising the skill of the play specialist to choose and implement techniques in an individualised approach to each child.

This study aims to deliver this semi-structured play therapy intervention and examine its impact on procedure-related anxiety, coping, pain and patient experience.

Eligibility criteria: Inclusion Criteria:

* Child or young person aged 5 to 17 years of age.
* Child under the care of the paediatric rheumatology team at Alder Hey Children's NHS Foundation Trust.
* Child must be expected to require at least 2 blood tests during the study period of 16 weeks as part of their routine care. All decisions regarding requirement for blood tests and/or procedures will be made solely on clinical grounds and not determined in any way by the study team.
* Sufficient time for assessment visit and preparation prior to first procedure.
* The parent or child if aged above 16 years of age has provided written, informed consent to participate in the study.
* The child aged less than 16 years has provided assent appropriate to their age.

Exclusion Criteria:

* Child unable to understand and complete Visual Analogue Scale (VAS) with support.
* Family unwilling to take part in study.
* Patient has previously received regular play therapy.
* Patient receiving psychology input for procedure-related anxiety or anxiety disorder.

Primary outcomes:
measure: Procedure-related anxiety visual analogue scale (VAS) score - completed by child
timeFrame: 1 year
Secondary outcomes:
measure: Observer procedure-related anxiety VAS score - completed by parent
timeFrame: 1 year
measure: Procedure-related coping VAS score - completed by child
timeFrame: 1 year
measure: Procedure-related pain VAS score - completed by child
timeFrame: 1 year
measure: Patient experience VAS score - completed by child and parent separately
timeFrame: 1 year
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: Merseyside
Study officials:
affiliation: Alder Hey Children's NHS Foundation Trust
name: Michael Beresford
role: PRINCIPAL_INVESTIGATOR
References: