Comparison of the efficacy of Valerian root extract and oral Diazepam on pre-operative anxiety before Orthopedic Surgeries

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013041112978N1

Enrollment

Registered

2014-06-24

Start date

2012-03-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Pre-operative Anxiety. Anxiety disorder unspecified

Interventions

Intervention 1: First Intervention group: Sedamin, Capsule, 530mg, once, The night before of surgery. Intervention 2: Control group: Starch, Placebo Capsule, once, The night before of surgery. Interve

Prevention

Placebo

First Intervention group: Sedamin, Capsule, 530mg, once, The night before of surgery

Control group: Starch, Placebo Capsule, once, The night before of surgery

secondary Intervention group: Diazepam, Tablet, 5mg, once, The night before of surgery

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Criterions of entering to the study: complete awareness, being capable at reading and writing at the lowest level, passing first and second grade of USA anesthesia assembly (ASA). Not having any records of mental and neurotic problems. Not using narcotics. Not being alcoholic.Criterions of exiting from study: being extremely anxious (the grade of obvious anxiety be more than 64 or the grade of covert anxiety be more than 62). Using anti anxiety or tranquilizer medicines.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Anxiety. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in Operation Room. Method of measurement: The State-Trait Anxiety Inventory(STAI).	—

Secondary

Measure	Time frame
Pulse Rate. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in Operation Room. Method of measurement: Computation of Pulse Rate in one minute.;Blood Pressure. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in operation room. Method of measurement: Stethoscope and Handheld Manometer.;Respiratory Rate. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in operation room. Method of measurement: Computation of Respiratory Rate in one minute.	—

Measure

Time frame

Pulse Rate. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in Operation Room. Method of measurement: Computation of Pulse Rate in one minute.;Blood Pressure. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in operation room. Method of measurement: Stethoscope and Handheld Manometer.;Respiratory Rate. Timepoint: The night before surgery in Ward(before Drug or Placebo use) and the morning of surgery in operation room. Method of measurement: Computation of Respiratory Rate in one minute.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Javad Shahinfar

North Khorasan University of Medical Sciences

jshahinfar@yahoo.com+98 58 4229 6787

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026