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

NCT07408921 | Recruiting

• 1 other identifier: TU-BOZKUL-015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drain

Keywords

Ice Pack; Warm Gel Pad; Anxiety; Comfort; Physiological Parameters; Patient Satisfaction

Outcome Measures

Primary Outcomes (7)

• Anxiety

  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,

  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

  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

  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

  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

  In this form, respiratory rate measured in the intervention and control groups before and after the procedure will be recorded.

  10 months

• Physiological Parameters

  In this form, pulse rate measured in the intervention and control groups before and after the procedure will be recorded.

  10 months

Study Arms (3)

Ice Pack Group

EXPERIMENTAL

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

Warm Gel Pad Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Ice Pack OTHER

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.

Ice Pack Group

Warm Gel Pad Group OTHER

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.

Warm Gel Pad Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead
• Mersin University: collaborator

Study Sites (1)

Tarsus University

Mersin, Turkey, 33400, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• https://doi.org/10.1002/nur.4770130405

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Murat Bozlu

  Mersin University

  PRINCIPAL INVESTIGATOR

• NACİYE BALBAY

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Bozkul

CONTACT

+903246000033; gamze.bozkul@gmail.com

Gülay ALTUN UĞRAŞ

CONTACT

gulaltun@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assignment of the patients included in the study to the groups will be performed by a researcher (GAU) who is not involved in the data collection process, using a simple randomization method with a random numbers table. The table will be generated using the website https://www.randomizer.org/ . When a patient who has undergone open urological surgery is admitted to the urology clinic, researchers GB and NB will assess the patients in terms of the inclusion criteria. The decision to remove the surgical drain, based on the evaluation that the drain has completed its function or that the indication for drainage has resolved, will be made by researcher MB and communicated to researchers GB and NB. When a patient who meets the inclusion criteria of the study and signs the informed consent form is identified, GB and NB will inform researcher GAU, and GAU will notify GB and NB of the group to which the patient will be assigned. In this manner, all researchers except GAU, as well as the pati
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was planned as a randomized controlled experimental study

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 13, 2026
• Study Start: February 15, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)