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DrainNCT07408921

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

A study testing Ice Pack and Warm Gel Pad Group in people with Drain, run by Tarsus University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Drain
What is being tested?
Ice Pack and Warm Gel Pad Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2026to 15 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tarsus University

    Mersin, Turkey, 33400

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Drain
Being tested
Ice Pack, Warm Gel Pad Group
Keywords
Ice Pack, Warm Gel Pad, Anxiety, Comfort, Physiological Parameters, Patient Satisfaction
Medical subject headings
Anxiety Disorders, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ice PackOther

    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 GroupOther

    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 groups in NCT07408921
Study groupRoleWhat they receive
Ice Pack GroupExperimentalIn 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.
Receives: Other: Ice Pack
Warm Gel Pad GroupExperimentalIn 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.
Receives: Other: Warm Gel Pad Group
Control groupNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 months

  2. 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.

    Measured: 10 months

  3. Physiological Parameters

    In this form, systolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.

    Measured: 10 months

  4. 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

    Measured: 10 months

  5. Physiological Parameters

    In this form, diastolic blood pressure measured in the intervention and control groups before and after the procedure will be recorded.

    Measured: 10 months

  6. Physiological Parameters

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

    Measured: 10 months

  7. Physiological Parameters

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

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion15 Oct 2026
  4. Study completion15 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study was planned as a randomized controlled experimental study
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408921
Sponsor's protocol ID
TU-BOZKUL-015
Status last verified
Oct 2026
First submitted
3 Feb 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 26890474
  • https://doi.org/10.1002/nur.4770130405

Questions about this trial

What is this clinical trial studying?

A study testing Ice Pack and Warm Gel Pad Group in people with Drain, run by Tarsus University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: 10 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408921, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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