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PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study) (PLAYTIME)

This study is currently recruiting participants.
Verified January 2017 by Alder Hey Children's NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832050
First Posted: July 13, 2016
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust
  Purpose

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

Condition Intervention
Pain Anxiety Rheumatology Behavioral: Play therapy Behavioral: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)

Resource links provided by NLM:


Further study details as provided by Alder Hey Children's NHS Foundation Trust:

Primary Outcome Measures:
  • Procedure-related anxiety visual analogue scale (VAS) score - completed by child [ Time Frame: 1 year ]
    Procedure-related anxiety visual analogue scale (VAS) score - completed by child


Secondary Outcome Measures:
  • Observer procedure-related anxiety VAS score - completed by parent [ Time Frame: 1 year ]
    Observer procedure-related anxiety VAS score - completed by parent can improve ability to cope with a procedure.

  • Procedure-related coping VAS score - completed by child [ Time Frame: 1 year ]
    Procedure-related coping VAS score - completed by child

  • Procedure-related pain VAS score - completed by child [ Time Frame: 1 year ]
    Procedure-related pain VAS score - completed by child

  • Patient experience VAS score - completed by child and parent separately [ Time Frame: 1 year ]
    Patient experience VAS score - completed by child and parent separately


Estimated Enrollment: 60
Actual Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention

The play therapy intervention consists of a standard of care delivered by a play specialist. The play specialist delivers interventions aimed in assisting the child through the process of undergoing procedures. The intervention is semi-structured in order to facilitate a systematic approach which remains individualised and child-centred.

The intervention requires patients to be classified as 'high risk' or 'low risk' for procedure-related anxiety. This is assessed for all patients at baseline based on parent and clinician opinion. The play specialist may re-classify patients at the initial assessment or at any point whilst working with the child. If this occurs, clear documentation of the rationale for this will be recorded. Patients classified as "high risk" receive additional preparation sessions as detailed in the standard of care.

Behavioral: Play therapy
See previous description of play therapy intervention arm.
Placebo Comparator: Comparator
The comparator group will receive standard care of patients having blood tests within the Trust, which does not include the specific intervention of a play therapist routinely. As part of standard care if a child becomes particularly distressed a clinician may make a decision to refer the child for play therapy. If this occurs during the study period the child will be referred to the play specialist delivering the intervention for the study. The child will then receive play therapy as in the described intervention. They will be excluded from the main analysis but data will still be collected and analysed descriptively.
Behavioral: Standard of care
See previous description of comparator arm.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832050


Contacts
Contact: Hanna Lythgoe 0151 252 5570 hannalythgoe@doctors.org.uk
Contact: Lucy Cooper, MSc 0151 252 5570 ext 3953 lucy.cooper@alderhey.nhs.uk

Locations
United Kingdom
Alder Hey Children's Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
Investigators
Principal Investigator: Michael Beresford Alder Hey Children's NHS Foundation Trust
  More Information

Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02832050     History of Changes
Other Study ID Numbers: 197779
First Submitted: February 15, 2016
First Posted: July 13, 2016
Last Update Posted: May 30, 2017
Last Verified: January 2017

Keywords provided by Alder Hey Children's NHS Foundation Trust:
play
therapy