An interventional study of Ice pack and warm gel pad in Pain, Anxiety and Children, sponsored by Tarsus University. Not yet recruiting. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Tarsus University · Not applicable, Interventional, and Other
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
Non-pharmacologic methods can be used to reduce pain during drain removal. One of these methods is cold application. Cold application shows a local anesthetic effect in the application area by increasing the release of endogenous opioids by stimulating touch receptors based on the gate control theory and the pain felt is reduced as a result of these mechanisms.
It is thought that ice pack and warm gel ice applications to be used during drain removal in pediatric patients may be a non-pharmacologic method for surgical drain removal and will contribute to comprehensive research on this subject.
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
Ice pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure.
Warm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 108 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Tarsus University is the lead sponsor of 78 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Ice pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure.
Other: Ice pack
Warm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
Other: warm gel pad
Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure.
The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated.
Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
State-Trait Continuity Inventory for Children
State-Trait Continuity Inventory for Children : The inventory, which is used to measure the state and trait anxiety states of children, was developed by Spielberger in 1973. It is a simplified form of the State-Trait Anxiety Inventory developed for adults for children. While the number of options was 4 in the adult form, it was reduced to 3 in the child form. Özusta translated the inventory into Turkish and conducted an application study.
Time frame: 1 hour
Pain level
Numerical Pain Scale : This method, which aims to determine the severity of pain, aims to explain the patient\'s pain in numbers. On numerical scales, absence of pain (0) is evaluated as unbearable pain (10).
Time frame: 1 hour
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Tarsus University