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| Name | Class |
|---|---|
| Baltalimani Bone Diseases Research and Training Hospital | OTHER_GOV |
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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:
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:
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:
Active Comparator Arm
Intervention Name: Standard Clinical Care
Description: Routine postoperative care according to hospital protocol, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold and arm sling elevation pillow | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İlke Karabıyık Demir, PhD Student | Contact | +905419762442 | ilkekarabyk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seda Çağlar, Assoc. Prof. Dr. | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital | Istanbul | Sarıyer | Turkey (Türkiye) |
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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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).
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To ensure the objectivity of the study findings, a single-blind design is employed. While the participants and investigators are aware of the intervention due to its physical nature, the data collector (outcome assessor) is a clinical nurse who is blinded to the group assignments of the children. This assessor performs the observations and administers the scales (STAIC and CCBC) without knowledge of whether the child is in the experimental or control group.
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| Standard postoperative care | Other | Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic. |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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