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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251118068036N3

Enrollment

105

Registered

2026-05-16

Start date

2026-06-06

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Zarei

Hamedan University of Medical Sciences

DR.MOHSENZAREI1206@GMAIL.COM+98 81 3131 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026