---
title: Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery
nct_id: NCT06997263
overall_status: COMPLETED
phase: NA
sponsor: Benha University
study_type: INTERVENTIONAL
primary_condition: Anxiety
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06997263.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06997263"
ct_last_update_post_date: 2025-06-11
last_seen_at: "2026-05-12T06:38:27.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

**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

**NCT ID:** [NCT06997263](https://clinicaltrials.gov/study/NCT06997263)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 96
- **Lead Sponsor:** Benha University
- **Conditions:** Anxiety, Postoperative Pain, Anesthesia
- **Start Date:** 2024-01-15
- **Completion Date:** 2025-01-15
- **CT.gov Last Update:** 2025-06-11

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patients with a history of uncontrolled hypertension
* Ischemic heart disease
* Uncontrolled diabetes
* Bronchial asthma
* Psychiatric illness
* Sleep disorders
* Obesity (Body mass index \>30 kg/m2)
* Patients taking antipsychotic, antidepressants, sedatives, anxiolytics, and anti-epileptic drugs.
* Pregnant and lactating females .
```

## Arms

- **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.
- **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.
- **Control Grou** (NO_INTERVENTION) — Participants in this group will receive no premedication with anxiolytic drugs prior to surgery.

## Interventions

- **Melatonin 3 mg Sublingual** (DRUG) — 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 Sublingual** (DRUG) — 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.

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- Benha University, Banhā, Qualiobia, Egypt

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.benha university|banhā|qualiobia|egypt` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06997263*  
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