Urological SurgeryNCT06910345
Effect of Melatonin Patches on Sleep in Urological Surgery
A study testing 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 in people with Urological Surgery, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urological Surgery
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2024to 15 May 2025
- 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
- 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.
Who cannot join
- •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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urological Surgery
- Being tested
- 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
- Keywords
- transdermal melatonin,, urological surgery, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 sleepOther
A skin patch (2.1 mg melatonin) was applied to the melatonin group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The Richards-Campbell Sleep Scale will be completed at 20:00 the evening before surgery and at 06:00 the morning of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start25 Feb 2024
- Primary completion20 Mar 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urological SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910345
- Sponsor's protocol ID
- 09/06 number, 19.11.2024
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 19606092
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin Patches on Sleep Quality in Patients Undergoing Urological Surgery
- ClinicalTrials.gov ID
- NCT06910345
- Acronym / sponsor ID
- 09/06 number, 19.11.2024
- Conditions
- Urological Surgery
- Keywords
- transdermal melatonin,, urological surgery, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | 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 sleepBefore 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. |
| control group | No intervention | –Patients in the control group will not undergo any intervention other than the standard care protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have undergone planned urological surgery,
Key exclusion criteria (3 listed)
- •Patients who used different sleeping pills/hypnotics during the study period,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 sleepA skin patch (2.1 mg melatonin) was applied to the melatonin group. | Other | Melatonin group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Results publication: PubMed 19606092Aeschbach 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Urological Surgery, run by Atlas 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 4 inclusion and 3 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 26 Nov 2025. 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?
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.). 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 NCT06910345, which also lists 1 linked publication.
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 26 Nov 2025.