AnxietyNCT06997263
Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery
A study testing Melatonin 3 mg Sublingual and Melatonin 6 mg Sublingual in people with Anxiety and Postoperative Pain, run by Benha University at 1 site in Egypt.
Trial summary
This prospective randomized controlled study aims to evaluate the anxiolytic effect of preoperative sublingual melatonin and its impact on postoperative pain scores when administered in two different doses to female patients undergoing elective gynecological surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Postoperative Pain, Anesthesia
- What is being tested?
- Melatonin 3 mg Sublingual and Melatonin 6 mg Sublingual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Jan 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patient scheduled for open elective gynecological surgeries (hysterectomy, ovarian cystectomy, myomectomy)
- Age 18-65 y
- American Society of Anesthesiologists (ASA) physical status (ASA I -II)
Who cannot join
- Patients with a history of uncontrolled hypertension
- Ischemic heart disease
- Uncontrolled diabetes
- Bronchial asthma
- Psychiatric illness
- Sleep disorders
Show all 9Show fewer
- Obesity (Body mass index >30 kg/m2)
- Patients taking antipsychotic, antidepressants, sedatives, anxiolytics, and anti-epileptic drugs.
- Pregnant and lactating females .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Different Doses of Sublingual Melatonin to Alleviate Anxiety and Pain Associated With Elective Gynecological Surgeries Under General Anesthesia: A Randomized Controlled Trial
This prospective randomized controlled study aims to evaluate the anxiolytic effect of preoperative sublingual melatonin and its impact on postoperative pain scores when administered in two different doses to female patients undergoing elective gynecological surgeries.
Read the detailed description
Elective gynecological surgery plays a vital role in women's healthcare, addressing a wide range of medical conditions from benign disorders to oncological diseases. Despite its importance, these procedures often lead to significant preoperative anxiety and postoperative pain, which can adversely affect patient recovery and satisfaction. The psychological impact is particularly prominent in gynecologic surgeries due to factors such as loss of fertility, body image concerns, and invasiveness of the procedures.
The perioperative period is a time of heightened vulnerability, with anxiety potentially leading to physiological stress responses that may compromise surgical outcomes and increase morbidity. Common sources of this anxiety include fear of anesthesia, postoperative pain, surgical failure, and loss of personal control.
To address these concerns, various pharmacologic agents such as benzodiazepines, non-steroidal anti-inflammatory drugs, and opioids have been used. However, these drugs may have limitations or side effects. Recently, melatonin, a naturally occurring hormone involved in regulating the sleep-wake cycle, has been proposed as a promising alternative due to its anxiolytic and analgesic effects. It is considered safe, well-tolerated, and easy to administer.
Sublingual melatonin offers advantages such as rapid absorption and good bioavailability, making it a practical option for preoperative use. This study will explore the comparative efficacy of two different sublingual doses of melatonin on reducing anxiety and postoperative pain in women undergoing elective gynecologic surgery under general anesthesia.
- Conditions
- Anxiety, Postoperative Pain, Anesthesia
- Being tested
- Melatonin 3 mg Sublingual, Melatonin 6 mg Sublingual
- Keywords
- Melatonin, Sublingual Melatonin, Hysterectomy, Ovarian Cystectomy, Myomectomy, Anxiety Reduction, Pain Management, Premedication
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mg SublingualDrug
A single 3 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the Low-Dose Melatonin Group.
Melatonin 6 mg SublingualDrug
A single 6 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the High-Dose Melatonin Group.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Melatonin Group | Experimental | Participants in this group will receive 3 mg of sublingual melatonin the night before surgery and another 3 mg 1 hour before induction of general anesthesia. Receives: Drug: Melatonin 3 mg Sublingual |
| High-Dose Melatonin Group | Experimental | Participants in this group will receive 6 mg of sublingual melatonin the night before surgery and another 6 mg 1 hour before induction of general anesthesia. Receives: Drug: Melatonin 6 mg Sublingual |
| Control Grou | No intervention | Participants in this group will receive no premedication with anxiolytic drugs prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Anxiety Score (BAI)
Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is rated on a 4-point Likert scale (0-3), with total scores ranging from 0 to 63. Higher scores indicate more severe anxiety.
Measured: At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively
Secondary outcomes (5)
Postoperative Pain Intensity
Pain will be assessed using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will verbally rate their pain at multiple postoperative time points.
Measured: At 0, 1, 4, 12, and 24 hours postoperatively
Time to First Rescue Analgesia Request
Duration of postoperative analgesia will be measured as the time from Post-Anesthesia Care Unit (PACU) recovery to the first request for rescue analgesia (morphine), indicating when pain relief wears off.
Measured: Up to 24 hours postoperatively
Cumulative Postoperative Opioid Consumption
The total dose of intravenous morphine (mg) administered within the first 24 hours post-surgery to manage postoperative pain.
Measured: From Post-Anesthesia Care Unit (PACU) admission to 24 hours postoperatively
Post-Anesthesia Care Unit (PACU) Discharge Time
Time from surgery completion until the patient achieves an Aldrete Recovery Score ≥8, which qualifies them for discharge from Post-Anesthesia Care Unit (PACU). The score assesses activity, respiration, circulation, consciousness, and oxygen saturation (max score = 10).
Measured: Immediately postoperatively, assessed up to 2 hours
Length of Hospital Stay
Total time the patient remains hospitalized post-surgery until discharge.
Measured: From end of surgery to hospital discharge, typically 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start15 Jan 2024
- Primary completion10 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam AbdAllah Ahmed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997263
- Sponsor's protocol ID
- MS 25-03-2025
- Status last verified
- Jun 2025
- First submitted
- 30 Dec 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Doses of Sublingual Melatonin to Alleviate Anxiety and Pain Associated With Elective Gynecological Surgeries Under General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06997263
- Acronym / sponsor ID
- MS 25-03-2025
- Conditions
- Anxiety, Postoperative Pain, Anesthesia
- Keywords
- Melatonin, Sublingual Melatonin, Hysterectomy, Ovarian Cystectomy, Myomectomy, Anxiety Reduction, Pain Management, Premedication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 30 May 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.
This prospective randomized controlled study aims to evaluate the anxiolytic effect of preoperative sublingual melatonin and its impact on postoperative pain scores when administered in two different doses to female patients undergoing elective gynecological surgeries.
Detailed description
Elective gynecological surgery plays a vital role in women's healthcare, addressing a wide range of medical conditions from benign disorders to oncological diseases. Despite its importance, these procedures often lead to significant preoperative anxiety and postoperative pain, which can adversely affect patient recovery and satisfaction. The psychological impact is particularly prominent in gynecologic surgeries due to factors such as loss of fertility, body image concerns, and invasiveness of the procedures.
The perioperative period is a time of heightened vulnerability, with anxiety potentially leading to physiological stress responses that may compromise surgical outcomes and increase morbidity. Common sources of this anxiety include fear of anesthesia, postoperative pain, surgical failure, and loss of personal control.
To address these concerns, various pharmacologic agents such as benzodiazepines, non-steroidal anti-inflammatory drugs, and opioids have been used. However, these drugs may have limitations or side effects. Recently, melatonin, a naturally occurring hormone involved in regulating the sleep-wake cycle, has been proposed as a promising alternative due to its anxiolytic and analgesic effects. It is considered safe, well-tolerated, and easy to administer.
Sublingual melatonin offers advantages such as rapid absorption and good bioavailability, making it a practical option for preoperative use. This study will explore the comparative efficacy of two different sublingual doses of melatonin on reducing anxiety and postoperative pain in women undergoing elective gynecologic surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Melatonin Group | Experimental | Drug: Melatonin 3 mg SublingualParticipants in this group will receive 3 mg of sublingual melatonin the night before surgery and another 3 mg 1 hour before induction of general anesthesia. |
| High-Dose Melatonin Group | Experimental | Drug: Melatonin 6 mg SublingualParticipants in this group will receive 6 mg of sublingual melatonin the night before surgery and another 6 mg 1 hour before induction of general anesthesia. |
| Control Grou | No intervention | –Participants in this group will receive no premedication with anxiolytic drugs prior to surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patient scheduled for open elective gynecological surgeries (hysterectomy, ovarian cystectomy, myomectomy)
- Age 18-65 y
- American Society of Anesthesiologists (ASA) physical status (ASA I -II)
Key exclusion criteria (9 listed)
- Patients with a history of uncontrolled hypertension
- Ischemic heart disease
- Uncontrolled diabetes
- Bronchial asthma
- Psychiatric illness
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 |
|---|---|---|
| Melatonin 3 mg SublingualA single 3 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the Low-Dose Melatonin Group. | Drug | Low-Dose Melatonin Group |
| Melatonin 6 mg SublingualA single 6 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the High-Dose Melatonin Group. | Drug | High-Dose Melatonin Group |
Primary outcome
Change in Preoperative Anxiety Score (BAI)
Time frame: At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively
Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is rated on a 4-point Likert scale (0-3), with total scores ranging from 0 to 63. Higher scores indicate more severe anxiety.
5 secondary outcomes
Postoperative Pain Intensity
Time frame: At 0, 1, 4, 12, and 24 hours postoperatively
Time to First Rescue Analgesia Request
Time frame: Up to 24 hours postoperatively
Cumulative Postoperative Opioid Consumption
Time frame: From Post-Anesthesia Care Unit (PACU) admission to 24 hours postoperatively
Post-Anesthesia Care Unit (PACU) Discharge Time
Time frame: Immediately postoperatively, assessed up to 2 hours
Length of Hospital Stay
Time frame: From end of surgery to hospital discharge, typically 1-3 days
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 11 Jun 2025.
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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 Melatonin 3 mg Sublingual and Melatonin 6 mg Sublingual in people with Anxiety and Postoperative Pain, run by Benha University at 1 site in Egypt.
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 3 inclusion and 9 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 11 Jun 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 Egypt. 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?
Change in Preoperative Anxiety Score (BAI) (time frame: At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.