Effect of Ice Pack and Warm Gel Pad Use During Drain Removal on Anxiety, Comfort, Physiological Parameters, and Patient Satisfaction Undergoing Open Urological Surgery

Официальное название

Effect of Ice Pack and Warm Gel Pad Use During Drain Removal on Anxiety, Comfort, Physiological Parameters, and Patient Satisfaction in Patients Undergoing Open Urological Surgery: A Randomized Controlled Trial

Обзор

The study was planned as a randomized controlled experimental study to determine the effects of ice pack and warm gel pad application during drain removal on anxiety, comfort, hemodynamic parameters, and patient satisfaction in patients undergoing open urological surgery. In the analysis, the ANOVA: Repeated Measures, Between Factors test was used, with an effect size of f = 0.25 (Kang, 2021), a significance level of α = 0.05, and a power (1-β) of 0.80. Based on the assumption of three groups and two measurement times, the minimum total sample size required for the study was calculated as 120 participants (ice pack group: 40, warm gel pad group: 40, control group: 40). A post hoc power analysis will be performed at the end of the study. Fifteen minutes before the procedure, patients will complete the Descriptive Information Form, State Anxiety Inventory, and Hemodynamic Variables Monitoring Form. After completing and recording the forms, participants will be assigned to either the intervention or control group according to the randomization schedule. In the ice pack group, when the decision is made to remove the surgical drain, the drain site will be disinfected before and after each procedure using a 70% isopropyl alcohol (IPA)-based solution. A 17 × 9 cm ice pack stored at -10°C will be wrapped in sterile gauze and applied to the drain site for approximately 10 minutes. The temperature of the application area will be measured at one-minute intervals using a calibrated infrared thermometer. When the area reaches a temperature of 13.6°C, the physician will be informed and the drain removal procedure will be initiated. In the warm gel pad group, the drain site will be assessed for integrity and leakage before and after each procedure, disinfected using 70% IPA, and then covered with a 15 × 8 cm gel pad kept at room temperature. The gel pad will be applied around the drain and covered with sterile sponges. After approximately 10 minutes of application, the drain will be removed by the physician. In the control group, when the decision is made to remove the surgical drain, the procedure will be performed by the physician and routine clinical practices will be applied. After the procedure, patients will complete the Satisfaction Assessment Scale, Comfort Assessment Scale, State Anxiety Inventory, and Hemodynamic Variables Monitoring Form.

Подробное описание

The study was planned as a randomized controlled experimental study to determine the effects of ice pack and warm gel pad application during drain removal on anxiety, comfort, hemodynamic parameters, and patient satisfaction in patients undergoing open urological surgery. The study will be conducted between February 2026 and February 2027 with individuals who apply to the Urology Department of Mersin University Hospital during this period and meet the sample inclusion criteria.

The sample size of the study was calculated using an a priori power analysis with the G\*Power 3.1 program. In the analysis, the ANOVA: Repeated Measures, Between Factors test was used, with an effect size of f = 0.25 (Kang, 2021), a significance level of α = 0.05, and a power (1-β) of 0.80. Based on the assumption of three groups and two measurement times, the minimum total sample size required for the study was calculated as 120 participants (ice pack group: 40, warm gel pad group: 40, control group: 40). A post hoc power analysis will be performed at the end of the study.

Data will be collected using the Descriptive Information Form, Satisfaction Assessment Scale, Comfort Assessment Scale, State Anxiety Inventory, and Hemodynamic Variables Monitoring Form. Fifteen minutes before the procedure, patients will complete the Descriptive Information Form, State Anxiety Inventory, and Hemodynamic Variables Monitoring Form. After completing and recording the forms, participants will be assigned to either the intervention or control group according to the randomization schedule.

In the ice pack group, when the decision is made to remove the surgical drain, the drain site will be disinfected before and after each procedure using a 70% isopropyl alcohol (IPA)-based solution. A 17 × 9 cm ice pack stored at -10°C will be wrapped in sterile gauze and applied to the drain site for approximately 10 minutes. The temperature of the application area will be measured at one-minute intervals using a calibrated infrared thermometer. When the area reaches a temperature of 13.6°C, the physician will be informed and the drain removal procedure will be initiated.

In the warm gel pad group, the drain site will be assessed for integrity and leakage before and after each procedure, disinfected using 70% IPA, and then covered with a 15 × 8 cm gel pad kept at room temperature. The gel pad will be applied around the drain and covered with sterile sponges. After approximately 10 minutes of application, the drain will be removed by the physician.

In the control group, when the decision is made to remove the surgical drain, the procedure will be performed by the physician and routine clinical practices will be applied.

After the procedure, patients will complete the Satisfaction Assessment Scale, Comfort Assessment Scale, State Anxiety Inventory, and Hemodynamic Variables Monitoring Form.

Вмешательства

• Другое Ice Pack
  In the ice pack group, when the decision is made to remove the surgical drain, the drain site will be disinfected before and after each procedure using a 70% isopropyl alcohol (IPA)-based solution. A 17 × 9 cm ice pack stored at -10°C will be wrapped in sterile gauze and applied to the drain site for approximately 10 minutes. The temperature of the application area will be measured at one-minute intervals using a calibrated infrared thermometer. When the area reaches a temperature of 13.6°C, the
• Другое Warm Gel Pad Group
  In the warm gel pad group, the drain site will be assessed for integrity and leakage before and after each procedure, disinfected using 70% IPA, and then covered with a 15 × 8 cm gel pad kept at room temperature. The gel pad will be applied around the drain and covered with sterile sponges. After approximately 10 minutes of application, the drain will be removed by the physician.

Первичные конечные точки

• Anxiety [Срок оценки: 10 months]
• Comfort, [Срок оценки: 10 months]
• Physiological Parameters [Срок оценки: 10 months]
• Patient Satisfaction [Срок оценки: 10 months]
• Physiological Parameters [Срок оценки: 10 months]
• Physiological Parameters [Срок оценки: 10 months]
• Physiological Parameters [Срок оценки: 10 months]

Критерии участия

Критерии включения

• Individuals who consented to participate in the study,
• Patients who underwent open urological surgery,
• Patients followed with a single surgical drain,
• Aged 18 years and older,
• Conscious, oriented, and cooperative,
• Without communication problems.

Критерии исключения

• Individuals who did not consent to participate in the study,
• Under 18 years of age,
• Not conscious, oriented, or cooperative,
• With communication problems,
• Having had a surgical drain previously,
• Individuals with two or more surgical drains.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Tarsus University — Mersin

Публикации

• Borofsky MS, Lingeman JE. The role of open and laparoscopic stone surgery in the modern era of endourology. Nat Rev Urol. 2015 Jul;12(7):392-400. doi: 10.1038/nrurol.2015.141. Epub 2015 Jun 16. PMID 26077995
• Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30. PMID 34325496
• Celebi C, Sivrikaya I, Olmez H, Guvenc SI, Urkan M. Effectiveness of cold application and lavender oil on pain during drain removal: A randomized clinical trial. Niger J Clin Pract. 2023 Aug;26(8):1101-1109. doi: 10.4103/njcp.njcp_881_22. PMID 37635603
• Kriegmair MC, Mandel P, Krombach P, Donmez H, John A, Hacker A, Michel MS. Drain placement can safely be omitted for open partial nephrectomy: Results from a prospective randomized trial. Int J Urol. 2016 May;23(5):390-4. doi: 10.1111/iju.13063. Epub 2016 Feb 18. PMID 26890474
• https://doi.org/10.1002/nur.4770130405

Идентификаторы

NCT: NCT07408921 · TU-BOZKUL-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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