Effect of Melatonin Patches on Sleep in Urological Surgery

NCT06910345 | Completed

• 1 other identifier: 09/06 number, 19.11.2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urological Surgery

Keywords

transdermal melatonin,; urological surgery; sleep quality

Outcome Measures

Primary Outcomes (1)

• sleep quality

  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.

Study Arms (2)

Melatonin group

EXPERIMENTAL

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

control group

NO INTERVENTION

Patients in the control group will not undergo any intervention other than the standard care protocol.

Interventions

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 OTHER

A skin patch (2.1 mg melatonin) was applied to the melatonin group.

Melatonin group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Aeschbach D, Lockyer BJ, Dijk DJ, Lockley SW, Nuwayser ES, Nichols LD, Czeisler CA. Use of transdermal melatonin delivery to improve sleep maintenance during daytime. Clin Pharmacol Ther. 2009 Oct;86(4):378-82. doi: 10.1038/clpt.2009.109. Epub 2009 Jul 15.

  PMID: 19606092 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: None (Open Label)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start: February 25, 2024
• Primary Completion: March 20, 2025
• Study Completion: May 15, 2025
• Last Updated: November 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: April 15, 2025

Locations

TU (1)