Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-24 @ 3:51 AM
Study NCT ID:
NCT02832050
Status:
WITHDRAWN
Last Update Posted:
2024-01-30
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)
Sponsor:
Alder Hey Children's NHS Foundation Trust
Organization:
Study Overview
Official Title:
PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
3 participants screened, all failed screening process
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAYTIME
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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: