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IRCT20251118068036N3 IRCT 2026-05-16 Hamedan University of Medical Sciences Comparing the effects of melatonin and orange blossom water on sleep and anxiety in patients before surgery Comparison of the effects of melatonin tablets and orange blossom water on sleep quality and preoperative anxiety in patients undergoing elective surgery. 2026-06-06 anticipated 105 Recruiting https://irct.ir/trial/89931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Comparison of the effects of melatonin tablets and orange blossom water on sleep quality and preoperative anxiety in patients undergoing elective surgery.. Intervention 1: Intervention group: Melatonin group (first intervention group): Intervention: Taking one 5 mg melatonin tablet orally. Time of administration: The night before surgery. Administration method: The drug is administered in identical packaging and coded by the researcher and under direct supervision to prevent bias. Intervention 2: Intervention group: Orange juice group (second intervention group):Intervention: Consumption of 15 ml of industrialized and standardized orange juice.Time of consumption: The night before surgery.Method of administration: The drug is administered in identical and coded packaging by the researcher and under direct supervision to prevent bias. Intervention 3: Control group: Placebo administration: The placebo is designed to look, taste (as much as possible) and be packaged similarly to melatonin tablets so that it is not visually or sensory different from the original drug. Time of administration: The night before surgery. Method of administration: The drug is administered in a similar, coded packaging by the researcher and under direct supervision to avoid bias. Yes - There is a plan to make this available What will be shared: Access to data will be available immediately after the final article is published. When: Access to data will be available immediately after the final article is published To whom: All researchers, researchers and clinical experts will be allowed to access the data of this study. Conditions: 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. Where to obtain: For more information, send an email to Dr. Mohsen Zarei. All correspondence will be addressed to DR.MOHSENZAREI1206@GMAIL.COM. How to obtain: After making a phone call and submitting a request via email, a final response will be sent within at least 1 month. Comments:
public Mohsen Zarei
Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 DR.MOHSENZAREI1206@GMAIL.COM Hamedan University of Medical Sciences scientific Mohsen Zarei
Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 DR.MOHSENZAREI1206@GMAIL.COM Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients between the ages of 18 and 65 years Candidate for elective (non-emergency) surgery Ability and willingness to participate in the study and complete the questionnaires 18 years 65 years Both Patients with a history of serious psychiatric disorders (such as major depression, bipolar disorder, schizophrenia) that may affect anxiety or sleep quality. Patients with known sleep disorders (e.g., sleep apnea, chronic insomnia) G47.0 Insomnia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Melatonin group (first intervention group): Intervention: Taking one 5 mg melatonin tablet orally. Time of administration: The night before surgery. Administration method: The drug is administered in identical packaging and coded by the researcher and under direct supervision to prevent bias. Intervention group: Orange juice group (second intervention group):Intervention: Consumption of 15 ml of industrialized and standardized orange juice.Time of consumption: The night before surgery.Method of administration: The drug is administered in identical and coded packaging by the researcher and under direct supervision to prevent bias. Control group: Placebo administration: The placebo is designed to look, taste (as much as possible) and be packaged similarly to melatonin tablets so that it is not visually or sensory different from the original drug. Time of administration: The night before surgery. Method of administration: The drug is administered in a similar, coded packaging by the researcher and under direct supervision to avoid bias. Anxiety. Timepoint: Pre-intervention (day of admission - baseline): First assessment to record the patient's baseline anxiety level.Post-intervention / Pre-operative (morning of surgery): Second assessment to measure changes in anxiety after receiving the intervention. Method of measurement: Patient completion of the STAI questionnaire.This questionnaire consists of 40 questions divided into two subscales: overt anxiety (current situation) and covert anxiety (personal trait).Responses are based on a 4-point Likert scale (very low, low, high, very high).Scoring involves weighting the responses (1 to 4) and, in some statements, reverse scoring.The final overall anxiety score is calculated in the range of 20 to 80. Need for sleep aids or sedatives after surgery. Timepoint: Postoperative: Record whether the patient required any adjunctive medications (such as benzodiazepines or other hypnotics) after surgery. Method of measurement: Through the patient's medical record or direct questioning of the patient/healthcare staff. Hamedan University of Medical Sciences Approved 2026-04-18 Research Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh St Hamadan Hamadan Iran (Islamic Republic of)