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Supracondylar Humerus FractureNCT05501834

Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial

A study testing Supracondylar Pin Removal After Imaging With VR, Supracondylar Pin Removal Before Imaging and Supracondylar Pin Removal Before Imaging With VR in people with Supracondylar Humerus Fracture and Anxiety, run by Boston Children's Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study aims to determine if removing supracondylar pins immediately following cast removal and prior to X-ray and/or using a VR headset during pin removal decreases patient and parent/guardian anxiety compared to pin removal following cast removal and X-ray and/or without the use of a VR headset. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Supracondylar Humerus Fracture, Anxiety
What is being tested?
Supracondylar Pin Removal After Imaging With VR, Supracondylar Pin Removal Before Imaging and Supracondylar Pin Removal Before Imaging With VR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
1 Apr 2024to 1 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged 3 to ≤10 years at time of surgery
  • Supracondylar humerus fractures that are laterally pinned at Boston Children's Hospital
  • Scheduled visit for pin removal at either Boston or Waltham orthopedic clinic by a study-participating physician
  • English speaking

Who cannot join

  • Documented history of seizure disorders or other neurological disorders.
  • Patients unwilling to follow up in Boston or Waltham BCH clinic locations

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Boston Children's Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

This study aims to determine if removing supracondylar pins immediately following cast removal and prior to X-ray and/or using a VR headset during pin removal decreases patient and parent/guardian anxiety compared to pin removal following cast removal and X-ray and/or without the use of a VR headset. The research team hypothesizes that patient anxiety response will be lower when pins are removed immediately following cast removal and will be lower when patient uses a VR headset 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.

Read the detailed description

Supracondylar humerus (SCH) fractures are one of the most common pediatric injuries.1-5 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.1,3,5 The median age of injury is between 3 and 8 years old, peaking at 5 to 6 years old.1,3 The gold standard for treating displaced SCH fractures is closed reduction and percutaneous pinning (CRPP);4,6-10 pins are almost always removed three to four weeks post-surgery in outpatient clinics, without anesthesia.11

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.12-14 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.15 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).16

Anxiety in the medical setting has been linked to future adverse effects for children.17-19 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.17,18 Preoperative anxiety in children also has been reported to have similar negative effects on behavior.20,21 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.6,22,23 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.17-19 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.

The use of virtual reality is currently being studied at several institutions as a form of distraction to reduce pain and anxiety in children during anxiety-inducing procedures, such as blood draws. It is evident from these recent studies that virtual reality successfully decreases the pain and anxiety in children when used in needle-related procedures.24-26 Procedure-related pain and anxiety were quantified using various pain scales and shown to be reduced in the VR groups, as compared with the controls.24-26 The pin removal procedure is known to produce elevated anxiety in patients, therefore we believe it is appropriate to apply this literature to our own research and determine anxiety levels after using VR during this procedure.

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. Thirdly, this study will aim to determine if the use of virtual reality (VR) has an influence on the patient anxiety response during the pin removal procedure.

Being tested
Supracondylar Pin Removal After Imaging With VR, Supracondylar Pin Removal Before Imaging, Supracondylar Pin Removal Before Imaging With VR
Keywords
Closed reduction percutaneous pinning, Supracondylar Humerus Fracture, Anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supracondylar Pin Removal After Imaging With VROther

    Patients in the treatment group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Wear the VR headset, 4. Have pins pulled in clinic room by provider.

  • Supracondylar Pin Removal Before ImagingOther

    Patients in the intervention 1 group will: 1. Go to cast room for cast removal, 2. Have pins pulled in cast room by provider, 3. Go to radiology for X-ray, 4. Have clinic visit with provider

  • Supracondylar Pin Removal Before Imaging With VROther

    Patients in the intervention group 2 will: 1. Go to cast room for cast removal, 2. Wear the VR headset, 3. Have pins pulled in cast room by provider, 4. Go to radiology for X-ray

Study groups in NCT05501834
Study groupRoleWhat they receive
Control GroupNo interventionArm 1: Control Group Patients in the control group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. 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 1ExperimentalArm 2: No change in clinic order, VR headset intervention Patients in arm two will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Receive a VR headset to wear while in clinic room, 4. Be seen in clinic room for pin removal
Receives: Other: Supracondylar Pin Removal After Imaging With VR
Intervention Group 2ExperimentalArm 3: Change in clinic order, no VR headset intervention Patients in arm three 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. Be seen in clinic room by provider
Receives: Other: Supracondylar Pin Removal Before Imaging
Intervention Group 3ExperimentalArm 4: Change in clinic order and VR headset intervention Patients in arm four will: 1. Receive a VR headset to wear while in cast room, 2. Go to cast room for cast removal, 3. Have pins immediately pulled after cast removal, 4. Go to radiology for X-ray, 5. Be seen in clinic room by provider
Receives: Other: Supracondylar Pin Removal Before Imaging With VR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Face, Legs, Activity, Cry and Consolability (FLACC) scale

    The Face, Legs, Activity, Cry and Consolability scale is validated in both young, non-verbal children and older, verbal children. The FLACC scale measures a patient's response to pain or distress using assessments of (1) facial expression, (2) leg movement, (3) activity, (4) extent to which they cried, and (5) extent to which they are consoled on a scale from 0 to 2 to generate a total score ranging from 0 (no pain/distress) to 10 (maximum pain/distress), with a higher score representing higher rates of anxiety and stress.

    Measured: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

  2. Heart rate

    Heart rate will be measured using a pulse oximetry heart rate monitor. We plan to use heart rate as a physiological correlate to the FLACC scale. For the purposes of this study, we will define an anxiety response as any patient who scores greater than 0 on the FLACC or achieves a HR in excess of the upper 95% normative limits for their age, sex and race (where applicable).

    Measured: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

Secondary outcomes (2)
  1. Spielberger State-Trait Anxiety Inventory (STAI-5)

    The Spielberger State-Trait Anxiety Inventory (STAI-5) has been widely used to measure the state and trait components of anxiety. The STAI has been shown to have excellent psychometric properties with good reliability and validity. The questionnaire can measure anxiety both in healthy and in clinical populations, with those scoring higher on STAI scales indicating to be more prone to experience anxiety. We plan to use this to measure the parent/guardian anxiety response to patient pin removal.

    Measured: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

  2. Timing

    The average length of time pin removal takes within each arm of the sturdy.

    Measured: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start1 Apr 2024
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501834
Sponsor's protocol ID
IRB-P00039559
Status last verified
Jun 2026
First submitted
2 Aug 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supracondylar Pin Removal After Imaging With VR, Supracondylar Pin Removal Before Imaging and Supracondylar Pin Removal Before Imaging With VR in people with Supracondylar Humerus Fracture and Anxiety, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Face, Legs, Activity, Cry and Consolability (FLACC) scale (time frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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