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Effect of Melatonin Patches on Sleep in Urological Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06910345
Enrollment
60
Registered
2025-04-04
Start date
2024-02-25
Completion date
2025-05-15
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological Surgery

Keywords

transdermal melatonin,, urological surgery, sleep quality

Brief summary

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.

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.

Interventions

OTHERA 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.

Sponsors

Atlas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

None (Open Label)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
sleep qualityThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026