Upper Extremity FracturesNCT07475975
The Effect of the Cold Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Children
A study testing Cold and arm sling elevation pillow and Standard postoperative care in people with Upper Extremity Fractures and Postoperative Anxiety, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to learn whether the use of a "cold and arm sling elevation pillow" affects anxiety and comfort levels in children aged 7-12 years undergoing surgery for upper extremity fractures. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Upper Extremity Fractures, Postoperative Anxiety, Patient Comfort
- What is being tested?
- Cold and arm sling elevation pillow and Standard postoperative care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Dec 2027
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years
- Scheduled for elective surgery with a diagnosis of upper extremity fracture
- Planned to receive analgesic treatment every 8 hours (three times daily) for postoperative pain management
- Fully oriented and without any condition that would impair communication or cooperation
- Expected to have a hospital stay of at least 24 hours in the orthopedic wards where the study is conducted
- Children and their parents/legal guardians who provide consent to participate in the study
Who cannot join
- Undergoing emergency surgical intervention
- Presence of an open wound, infection, suspected compartment syndrome, or vascular injury at the fracture site
- Presence of sensory loss or neurological deficit in the affected extremity
- Presence of cognitive, hearing, speech, or severe physical disabilities
- Treated conservatively with cast immobilization
- Planned postoperative analgesic regimens that are more frequent or less frequent than every 8 hours, or that require high-dose analgesic therapy
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- Requiring revision surgery
- Presence of metabolic or neuromuscular comorbidities (e.g., osteogenesis imperfecta, recurrent fractures)
- Children whose mothers are unable to communicate or do not speak Turkish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital
Istanbul, Sarıyer
İlke Karabıyık Demir, +905419762442, ilkekarabyk@gmail.com
About this study
Official title: The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures
The purpose of this clinical trial is to learn whether the use of a "cold and arm sling elevation pillow" affects anxiety and comfort levels in children aged 7-12 years undergoing surgery for upper extremity fractures. The main questions it aims to answer are:
- Does the use of a cold and arm sling elevation pillow reduce postoperative anxiety levels in children?
- Does the use of a cold and arm sling elevation pillow increase postoperative comfort levels in children?
Read more
Researchers will compare the experimental group (using the specially designed cold and arm sling elevation pillow) with the control group (receiving standard clinical care, including standard pillows and separate ice packs) to see the effects of the integrated pillow on anxiety and comfort.
Participants will:
- Receive education before surgery based on their randomly assigned group (experimental or control),
- Use the assigned elevation and cold application method for the first 24 hours following surgery,
- Complete anxiety and comfort assessment scales at four different time points: before the intervention, just before surgery, 6 hours after surgery, and at the time of discharge.
Read the detailed description
Experimental Arm
- Intervention Name: Cold and Arm Sling Elevation Pillow
- Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components:
- Elevation Module: Maintains the limb above heart level to reduce postoperative edema.
- Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours).
- Arm Sling Function: Adjustable straps allow the pillow to function as a stabilizer during mobilization. The device features a child-friendly "teddy bear" design to reduce medical anxiety.
Active Comparator Arm
- Intervention Name: Standard Clinical Care
- Description: Routine postoperative care according to hospital protocol, including:
- Elevation: Using standard hospital bed pillows to support the limb.
- Cold Application: Separate ice gel packs wrapped in gauze/towels, applied for 15-20 minutes every hour for the first 24 hours.
- Stabilization: Use of a standard fabric arm sling during patient mobilization
- Being tested
- Cold and arm sling elevation pillow, Standard postoperative care
- Keywords
- Postoperative Anxiety, Patient Comfort, Upper Extremity Fracture, Cold and arm sling elevation pillow, children
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold and arm sling elevation pillowDevice
Also called Experimental group
This intervention consists of a combined, non-pharmacological nursing approach that includes cold therapy, an arm sling, and an elevation pillow. The cold therapy, planned to reduce postoperative edema and pain, is designed to be integrated into the elevation pillow in a manner compatible with the arm sling. The elevation pillow used in this intervention is suitable for cold therapy and can be easily converted into an arm sling when needed. In addition, cold therapy can be maintained during mobilization when the elevation pillow is transformed into the arm sling form.
Standard postoperative careOther
Also called Control group
Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Cold and arm sling elevation pillow group | Experimental | Participants in this group will receive the 'Cold and Arm Sling Elevation Pillow' intervention. This specially designed supportive device integrates three functions: cold application, limb elevation, and arm sling support. The intervention will be applied in the postoperative period to improve patient comfort and reduce anxiety levels Receives: Device: Cold and arm sling elevation pillow |
| Control Group | Other | Participants in this group will receive standard postoperative nursing care as per the hospital's routine protocol. This includes elevation of the affected extremity using a standard pillow, cold application using ice gel packs wrapped in gauze, and the use of a standard arm sling during mobilization. Receives: Other: Standard postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Comfort will be assessed using the Child Comfort Behavior Checklist. The scale consists of five sub-dimensions ("Vocalizations," "Motor Symptoms," "Performance," "Facial Expressions," and "Other") with a total of 30 items. Items are scored on a 5-point Likert-type scale, ranging from 0 to 4 (Not applicable=0, None=1, Slightly=2, Moderate=3, Strong=4).
During the scoring phase, items scored as "0" (not applicable to the child's age or condition) are excluded from the total score calculation. The child's actual score is determined by dividing the total points by the potential maximum score achievable for that specific child. The maximum possible score for the scale is 100, where higher scores indicate higher levels of comfort (a more positive outcome).
Measured: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
Postoperative anxiety
State anxiety will be assessed using the State-Trait Anxiety Inventory for Children (STAI-C). Reverse-scored items will be scored according to standard scoring guidelines, with total scores ranging from 20 to 60, where higher scores indicate higher levels of state anxiety (representing a more negative outcome).
Measured: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled experimental study with a parallel-group design. Participants are assigned to either the experimental group (Cold and arm sling elevation pillow intervention) or the control group (standard clinical care) using a block randomization method. To prevent observer bias, the study is single-blinded; the data collector (outcome assessor) is a clinical nurse who is unaware of the group assignments. Data are collected at four distinct time points: baseline (T0), pre-surgery (T1), 6 hours post-surgery (T2), and at discharge (T3).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Baltalimani Bone Diseases Research and Training Hospital
- Responsible party
- Principal investigator, İlke Karabıyık Demir, Istanbul University - Cerrahpasa
- Investigators
- Seda Çağlar, Assoc. Prof. Dr., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475975
- Sponsor's protocol ID
- 1395301
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the pediatric participants and their families. Furthermore, as this study is part of a doctoral thesis project, the data are restricted for use in the current research and its associated academic publications according to the approved ethical protocol.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures
- ClinicalTrials.gov ID
- NCT07475975
- Acronym / sponsor ID
- 1395301
- Keywords
- Postoperative Anxiety, Patient Comfort, Upper Extremity Fracture, Cold and arm sling elevation pillow, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Baltalimani Bone Diseases Research and Training Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn whether the use of a "cold and arm sling elevation pillow" affects anxiety and comfort levels in children aged 7-12 years undergoing surgery for upper extremity fractures. The main questions it aims to answer are:
- Does the use of a cold and arm sling elevation pillow reduce postoperative anxiety levels in children?
- Does the use of a cold and arm sling elevation pillow increase postoperative comfort levels in children?
Researchers will compare the experimental group (using the specially designed cold and arm sling elevation pillow) with the control group (receiving standard clinical care, including standard pillows and separate ice packs) to see the effects of the integrated pillow on anxiety and comfort.
Participants will:
- Receive education before surgery based on their randomly assigned group (experimental or control),
- Use the assigned elevation and cold application method for the first 24 hours following surgery,
- Complete anxiety and comfort assessment scales at four different time points: before the intervention, just before surgery, 6 hours after surgery, and at the time of discharge.
Detailed description
Experimental Arm
- Intervention Name: Cold and Arm Sling Elevation Pillow
- Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components:
- Elevation Module: Maintains the limb above heart level to reduce postoperative edema.
- Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours).
- Arm Sling Function: Adjustable straps allow the pillow to function as a stabilizer during mobilization. The device features a child-friendly "teddy bear" design to reduce medical anxiety.
Active Comparator Arm
- Intervention Name: Standard Clinical Care
- Description: Routine postoperative care according to hospital protocol, including:
- Elevation: Using standard hospital bed pillows to support the limb.
- Cold Application: Separate ice gel packs wrapped in gauze/towels, applied for 15-20 minutes every hour for the first 24 hours.
- Stabilization: Use of a standard fabric arm sling during patient mobilization
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled experimental study with a parallel-group design. Participants are assigned to either the experimental group (Cold and arm sling elevation pillow intervention) or the control group (standard clinical care) using a block randomization method. To prevent observer bias, the study is single-blinded; the data collector (outcome assessor) is a clinical nurse who is unaware of the group assignments. Data are collected at four distinct time points: baseline (T0), pre-surgery (T1), 6 hours post-surgery (T2), and at discharge (T3).
| Arm | Type | Receives |
|---|---|---|
| Cold and arm sling elevation pillow group | Experimental | Device: Cold and arm sling elevation pillowParticipants in this group will receive the 'Cold and Arm Sling Elevation Pillow' intervention. This specially designed supportive device integrates three functions: cold application, limb elevation, and arm sling support. The intervention will be applied in the postoperative period to improve patient comfort and reduce anxiety levels |
| Control Group | Other | Other: Standard postoperative careParticipants in this group will receive standard postoperative nursing care as per the hospital's routine protocol. This includes elevation of the affected extremity using a standard pillow, cold application using ice gel packs wrapped in gauze, and the use of a standard arm sling during mobilization. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7-12 years
- Scheduled for elective surgery with a diagnosis of upper extremity fracture
- Planned to receive analgesic treatment every 8 hours (three times daily) for postoperative pain management
- Fully oriented and without any condition that would impair communication or cooperation
- Expected to have a hospital stay of at least 24 hours in the orthopedic wards where the study is conducted
Key exclusion criteria (9 listed)
- Undergoing emergency surgical intervention
- Presence of an open wound, infection, suspected compartment syndrome, or vascular injury at the fracture site
- Presence of sensory loss or neurological deficit in the affected extremity
- Presence of cognitive, hearing, speech, or severe physical disabilities
- Treated conservatively with cast immobilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold and arm sling elevation pillowAlso: Experimental groupThis intervention consists of a combined, non-pharmacological nursing approach that includes cold therapy, an arm sling, and an elevation pillow. The cold therapy, planned to reduce postoperative edema and pain, is designed to be integrated into the elevation pillow in a manner compatible with the arm sling. The elevation pillow used in this intervention is suitable for cold therapy and can be easily converted into an arm sling when needed. In addition, cold therapy can be maintained during mobilization when the elevation pillow is transformed into the arm sling form. | Device | Cold and arm sling elevation pillow group |
| Standard postoperative careAlso: Control groupStandard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic. | Other | Control Group |
Primary outcome
Comfort
Time frame: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
Comfort will be assessed using the Child Comfort Behavior Checklist. The scale consists of five sub-dimensions ("Vocalizations," "Motor Symptoms," "Performance," "Facial Expressions," and "Other") with a total of 30 items. Items are scored on a 5-point Likert-type scale, ranging from 0 to 4 (Not applicable=0, None=1, Slightly=2, Moderate=3, Strong=4). During the scoring phase, items scored as "0" (not applicable to the child's age or condition) are excluded from the total score calculation. The child's actual score is determined by dividing the total points by the potential maximum score achievable for that specific child. The maximum possible score for the scale is 100, where higher scores indicate higher levels of comfort (a more positive outcome).
Postoperative anxiety
Time frame: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
State anxiety will be assessed using the State-Trait Anxiety Inventory for Children (STAI-C). Reverse-scored items will be scored according to standard scoring guidelines, with total scores ranging from 20 to 60, where higher scores indicate higher levels of state anxiety (representing a more negative outcome).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the pediatric participants and their families. Furthermore, as this study is part of a doctoral thesis project, the data are restricted for use in the current research and its associated academic publications according to the approved ethical protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda Çağlar, Assoc. Prof. Dr. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold and arm sling elevation pillow and Standard postoperative care in people with Upper Extremity Fractures and Postoperative Anxiety, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 7 Jul 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 Turkey (Türkiye). 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?
Contact İlke Karabıyık Demir, PhD Student (+905419762442, ilkekarabyk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.). 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 7 Jul 2026.