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

March 3, 2026 updated by: Gamze BOZKUL, Tarsus University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ice Pack Group
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.
Other: 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.
Experimental: 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.
Other: 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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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.
10 months
Comfort,
Time Frame: 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.
10 months
Physiological Parameters
Time Frame: 10 months
In this form, systolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.
10 months
Patient Satisfaction
Time Frame: 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
10 months
Physiological Parameters
Time Frame: 10 months
In this form, diastolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.
10 months
Physiological Parameters
Time Frame: 10 months
In this form, respiratory rate measured in the intervention and control groups before and after the procedure will be recorded.
10 months
Physiological Parameters
Time Frame: 10 months
In this form, pulse rate measured in the intervention and control groups before and after the procedure will be recorded.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Collaborators

Mersin University

Investigators

  • Principal Investigator: Murat Bozlu, Mersin University
  • Principal Investigator: NACİYE BALBAY, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Borofsky, M. S., & Lingeman, J. E. (2015). The role of open and laparoscopic stone surgery in the modern era of endourology. Nature reviews. Urology, 12(7), 392-400. https://doi.org/10.1038/nrurol.2015.141
  • Kang H. (2021). Sample size determination and power analysis using the G*Power software. Journal of educational evaluation for health professions, 18, 17. https://doi.org/10.3352/jeehp.2021.18.17
  • Celebi, C., Sivrikaya, I., Olmez, H., Guvenc, S. I., & Urkan, M. (2023). Effectiveness of cold application and lavender oil on pain during drain removal: A randomized clinical trial. Nigerian journal of clinical practice, 26(8), 1101-1109. https://doi.org/10.4103/njcp.njcp_881_22
  • Kriegmair, M. C., Mandel, P., Krombach, P., Dönmez, H., John, A., Häcker, A., & Michel, M. S. (2016). Drain placement can safely be omitted for open partial nephrectomy: Results from a prospective randomized trial. International journal of urology : official journal of the Japanese Urological Association, 23(5), 390-394. https://doi.org/10.1111/iju.13063
  • https://doi.org/10.1002/nur.4770130405

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-BOZKUL-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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