Effect of Melatonin Patches on Sleep in Urological Surgery

November 21, 2025 updated by: Cagla Toprak, Atlas University

Effect of Melatonin Patches on Sleep Quality in Patients Undergoing Urological Surgery

Patients undergoing urological surgery may experience a decrease in sleep quality due to many factors such as hospitalization, different environment, pain, stress and anesthesia. After surgery, melatonin secretion decreases and circadian rhythm becomes irregular in patients. This problem can lead to sleep disorders in patients. Melatonin is an important hormone that regulates both sleep and circadian rhythms. The aim of this study is to observe the effect of a melatonin skin patch designed to produce melatonin in a way that ensures a stable increase in melatonin levels in the blood, on patients undergoing urological surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to observe the effect of a melatonin skin patch designed to produce melatonin, which would provide a stable increase in blood melatonin levels, on patients undergoing urological surgery. The patients were applied a melatonin patch before surgery. The other group received routine nursing care.

Study Type

Interventional

Enrollment (Actual)

60

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 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:

  • Patients who have undergone planned urological surgery,

    • Those who receive melatonin patch therapy,
    • Those who are between the ages of 18-70,
    • Those whose hemodynamic conditions are stable will be included.

Exclusion Criteria:

  • •Patients who used different sleeping pills/hypnotics during the study period,

    • Patients with delirium/psychiatric illness,
    • Patients with hearing and speech problems will not be included.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin group
Before the patient goes to sleep, the nurse will ensure that the room is quiet and dark, as exposure to light suppresses melatonin. First, the introductory characteristics form and the Richard's-Campbel Sleep Scale will be completed for patients assigned to the melatonin group. Melatonin patches will be placed by a nurse not involved in the study at 8:00 PM before going to sleep (on the upper chest or forearm, as determined by the patient). The patches will remain on for an average of 6-10 hours, depending on the patient's preferred sleep hygiene. If a patient wishes to have the patch removed during the night, they will be instructed to ask the clinic nurse to do this. The Richard's-Campbel Sleep Scale will be completed when the patient is fully awake after the melatonin patch is removed one hour before the patient goes to the operating room on the morning of the surgery.
Other: A skin patch (2.1 mg melatonin) was applied to the melatonin group. The melatonin patches will be placed at 8:00 PM (on the upper chest or forearm, as determined by the patient) before going to sleep
A skin patch (2.1 mg melatonin) was applied to the melatonin group.
No Intervention: control group
Patients in the control group will not undergo any intervention other than the standard care protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: The Richards-Campbell Sleep Scale will be completed at 20:00 the evening before surgery and at 06:00 the morning of surgery.
Sleep is examined in the parameter and scored between 100 'very suitable' and 0 'not suitable'. The higher the score obtained from the scale, the higher the patient's sleep quality is considered.
The Richards-Campbell Sleep Scale will be completed at 20:00 the evening before surgery and at 06:00 the morning of surgery.

Collaborators and Investigators

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

Sponsor

Atlas 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

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 (Actual)

February 25, 2024

Primary Completion (Actual)

March 20, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/06 number, 19.11.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

April 15, 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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