Ice Pack and Lukewarm Gel Pad Use on Pain, Anxiety Level and Physiological Parameters
NCT06600763 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2024-09-23
Summary
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
1. Phase: The necessary ethics committee and institutional permission will be obtained before starting the study.
2. Stage: The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician.
3. Stage: After obtaining written informed consent from the child\'s parents for the drain removal procedure, the researcher will explain the drain removal procedure and what will be done during the procedure to the parents. Then the descriptive information form will be filled.
4. Stage: Physiological parameters (pulse, blood pressure, respiration, SPO2 ) of the children will be measured by the researcher before and after the procedure.
5. Before the procedure, the necessary materials (ice pack or warm gel ice, infrared thermometer, gloves, saline, scalpel, clamp, sterile sponge, plaster and scissors) will be prepared and the drainage system will be clamped.
6. The parent and nurse will assess and record the child\'s pain score 15 minutes before, during and 15 minutes after the procedure. The child will be asked to make the same assessments and the results will be recorded.
Conditions
Interventions
- OTHER
-
Ice pack
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.
- OTHER
-
warm gel pad
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.
Sponsors & Collaborators
-
Tarsus University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-20
- Primary Completion
- 2025-02-25
- Completion
- 2025-05-31
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