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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 physician will be informed and the drain removal procedure will be initiated.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Anxiety — 10 months
  The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
• Comfort, — 10 months
  It is a scale that provides a subjective assessment of comfort on a horizontal or vertical line from 0 -10 to evaluate the level of comfort.
• Physiological Parameters — 10 months
  In this form, systolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.
• Patient Satisfaction — 10 months
  It is a scale that provides a subjective assessment of comfort on a horizontal or vertical line from 0 -10 to evaluate the level of patient satisfaction
• Physiological Parameters — 10 months
  In this form, diastolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.
• Physiological Parameters — 10 months
  In this form, respiratory rate measured in the intervention and control groups before and after the procedure will be recorded.
• Physiological Parameters — 10 months
  In this form, pulse rate measured in the intervention and control groups before and after the procedure will be recorded.

Trial sites (1)

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