Comparison of the effects of melatonin tablets and orange blossom water on sleep quality and preoperative anxiety in patients undergoing elective surgery.

Comparison of the effects of melatonin tablets and orange blossom water on sleep quality and preoperative anxiety in patients undergoing elective surgery.

Randomized, double-blind, active-controlled clinical trial with parallel design

This study will be conducted in the inpatient and admission departments of these educational and medical centers (Besat, Shahid Beheshti, and Ekbatan). Patients will be included in the study if they meet the inclusion criteria and give informed consent. Their demographic information will be recorded in a questionnaire and divided into three groups: spring orange, melatonin, and placebo.

Inclusion criteria: Patients aged 18 to 65 years Candidates for elective (non-emergency) surgery Ability and willingness to participate in the study and complete the questionnaires Exclusion criteria:Patients under 18 years of age or over 65 years Patients candidates for emergency surgery Patients with a history of serious psychiatric disorders (e.g., major depression, bipolar disorder, schizophrenia) that may affect anxiety or sleep quality Patients with known sleep disorders (e.g., sleep apnea, chronic insomnia)

Melatonin group: The night before surgery, they receive 5 mg of melatonin tablets. Orange blossom extract group: The night before surgery, they receive 15 ml of standard orange blossom extract. Placebo group (control): The night before surgery, they receive a placebo (with a similar appearance and taste).

Anxiety- quality of sleep

This study is a three-group, parallel, randomized controlled clinical trial that aims to compare the effects of melatonin tablets and orange blossom water on sleep quality and preoperative anxiety in patients aged 18 to 65 years who are candidates for elective surgery. Convenient sampling will be performed from patients referring to Besat, Shahid Beheshti, and Ekbatan educational and medical centers. The sample size is 105 people (35 people in each group), and the allocation of individuals to three groups of melatonin, orange blossom water, and placebo will be done using a block randomization method and using sealed and coded envelopes. The intervention will be performed the night before surgery; the melatonin group will receive 5 mg of oral melatonin, the orange blossom water group will receive 15 ml of standard industrial orange blossom water, and the control group will receive the same placebo.Data will be collected using a researcher-made checklist, Spielberger Anxiety Questionnaire, and Chen Sleep Quality Questionnaire on the day of admission (before the intervention) and on the morning of the operation. Inclusion criteria include no history of mental illness, no sensitivity to the intervention, no use of sedatives or hypnotics in the past month, and no severe heart, liver, or kidney diseases. The study is conducted with the approval of the Ethics Committee of Hamadan University of Medical Sciences and the license of the relevant medical centers.

The study will be conducted in a double-blind manner. Melatonin tablets, orange blossom water, and placebo will be identical in appearance and packaging and will be coded and prepared by someone other than the implementation team. Patients and outcome assessors will be unaware of the type of medication they receive. Allocation of interventions to patients will be done through sealed, coded, and confidential envelopes that will only be opened in emergency cases.

Access to data will be available immediately after the final article is published.

Access to data will be available immediately after the final article is published

All researchers, researchers and clinical experts will be allowed to access the data of this study.

It will be welcomed to conduct extensive analysis on the data of this study along with the data of other studies to write meta-analysis review articles.

For more information, send an email to Dr. Mohsen Zarei. All correspondence will be addressed to DR.MOHSENZAREI1206@GMAIL.COM.

After making a phone call and submitting a request via email, a final response will be sent within at least 1 month.