Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05501834 |
| Other study ID # |
IRB-P00039559 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Boston Children's Hospital |
| Contact |
Shannon McGurty, BS |
| Phone |
617-919-4209 |
| Email |
shannon.mcgurty[@]childrens.harvard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to determine if removing supracondylar pins immediately following cast
removal and prior to X-ray decreases patient and parent/guardian anxiety compared to pin
removal following cast removal and X-ray. The research team hypothesizes that patient anxiety
response will be lower when pins are removed immediately following cast removal compared to
our current standard of care. Secondarily, this study will determine if there is an
association between patient anxiety response and their parent's/guardian's anxiety.
Description:
Supracondylar humerus (SCH) fractures are one of the most common pediatric injuries. These
fractures are reported as the second most common pediatric fracture, constituting about 18%
of all pediatric fractures and approximately 60% of all elbow fractures. The median age of
injury is between 3 and 8 years old, peaking at 5 to 6 years old. The gold standard for
treating displaced SCH fractures is closed reduction and percutaneous pinning (CRPP); pins
are almost always removed three to four weeks post-surgery in outpatient clinics, without
anesthesia.
Many would assume that patients experience anxiety during pin removal, but no studies to our
knowledge quantified a patient's physiological and behavioral response during this procedure.
However, there have been many in-depth investigations of these responses during cast removal
procedures, where heart rate (HR) is used as a psychological indicator of anxiety.
Additionally, Merkel et al. developed the Face, Legs, Activity, Cry and Consolability (FLACC)
Scale which is a valid and reliable tool to quantify pain behaviors in children. Further
research showed that the FLACC Scale was also sensitive to painless procedures (i.e.
intravenous insertion), and therefore, it can be considered a composite of pain and distress
(anxiety).
Anxiety in the medical setting has been linked to future adverse effects for children.
Previous publications have shown that patients with anxiety in the perioperative setting have
increased postoperative pain, maladaptive behavior, and long-term anxiety with future medical
visits. Preoperative anxiety in children also has been reported to have similar negative
effects on behavior. It is plausible that an anxiety-provoking procedure, such as pin
removal, would have similar effects.
The primary purpose of the first phase of this study (IRB-P00028933), which took place from
2018 to 2020, was to quantify the anxiety experienced by patients undergoing pin removal in
clinic following closed reduction and percutaneous pinning (CRPP) for SCH fractures. Now that
the first phase is complete, the research team is interested in taking this research another
step forward to see how healthcare providers can reduce patient and parent anxiety in
clinical settings. Before the first phase of this study, there were no known studies that
quantified a patient's physiological and behavioral response during a postoperative pin
removal procedure, as CRPP is the gold standard treatment for displaced supracondylar humerus
(SCH) fractures. The findings of the primary purpose of the first phase ultimately
demonstrated that all patients undergoing pin removal experience an anxiety response,
therefore highlighting an area of clinical practice in need of a targeted to help decrease
patient anxiety and improve patient experience.
Patients currently proceed with the following clinical flow on the day of their pin removal:
(1) patients first present to the cast room for cast removal, (2) radiographs are obtained to
confirm alignment and fracture stability, and (3) patients are seen by their provider in an
orthopaedic clinic room for pin removal. While this process is streamlined in a busy
orthopaedic clinic, it could still take up to an hour of time. After cast removal may also be
the first time a patient sees the pins and this added time before pin removal could escalate
anxiety. It is evident in the literature that an X-ray prior to pin removal is unnecessary,
as it does not change clinical management. Anxiety in the medical setting has been linked to
future adverse effects for children, such as increased postoperative pain, maladaptive
behavior, and long-term anxiety with future medical visits. It is plausible that an
anxiety-provoking procedure, such as pin removal, could have similar effects. Ultimately, the
findings of the first phase of our study provide the groundwork for future research efforts
in techniques to minimize anxiety for the pediatric patient having to undergo pin removal.
Something as simple as changing the clinic flow of our current pin removal process, such as
removing pins immediately following cast removal and prior to X-ray, may decrease the overall
time waiting for pin removal and decrease patient anxiety.
Therefore, the primary aim of this study is to determine if removing supracondylar pins
immediately following cast removal and prior to X-ray decreases patient and parent/guardian
anxiety compared to pin removal following cast removal and X-ray. It is hypothesized that
patient anxiety response will be lower when pins are removed immediately following cast
removal compared to our current standard of care. Secondarily, this study will aim to
determine if there is an association between patient anxiety response and their
parent's/guardian's anxiety.
After consenting to participate in the trial, patients will be randomized to one of two
treatment arms--the intervention or the control-that will be evaluated for this study. We
will measure patient and parent/guardian anxiety on the day of pin removal. We plan to
randomize patients into two clinical flows: standard of care clinic flow (control treatment)
and change in clinic flow (new treatment).
Control Group Patients in the control group will: 1. Go to cast room for cast removal, 2. Go
to radiology for X-ray, 3. Will be seen in clinic room for pin removal. These steps are our
current standard of care. An orthopedic, cast room technician bivalves and removes the top
half of the patient's cast. In radiology, anteroposterior (AP) and lateral X-ray views are
obtained to confirm radiographic healing. In the clinic room, a surgeon or nurse removes the
pins using pin removal pliers.
Intervention Group Patients in the treatment group will: 1. Go to cast room for cast removal,
2. Have pins immediately pulled after cast removal, 3. Go to radiology for X-ray, 4. Will be
seen in clinic room by provider
In both groups, the study coordinator will record FLACC score and HR for patients and STAIS-5
score for parents/guardian. Training to administer the FLACC will include discussion led by
the PI (Yi-Meng Yen, MD, PhD) about the 5 categories, clarification of defining
characteristics for behaviors, and scoring techniques. Additionally, the study coordinator
has already been trained to administer the FLACC and can also teach other study coordinators.
If multiple study coordinators are used to administer the FLACC, reliability will be
assessed.
