Effects of preoperative oral Diazepam During Loop Electrosurgical Excision Procedure on Anxiety : a randomized trial

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240630006

Enrollment

154

Registered

2024-06-30

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Abnormal cervical cytology report And subsequent treatment procedures, such as colposcopy and LEEP, can cause significant anxiety and psychological distress. This is mostly due to fear of getting cancer and a lack of clear understanding of the treatment process. Oral Diazepam is anxiolytic drug that safe and available for preoperative treatment in many other procedure. We believe that Preoperative oral Diazepam can decrease anxiety before Loop Electrosurgical Excision Procedure. And it is

Interventions

Oral tablet diazepam 10 mg,placebo, use oral tablet folic acid 5 mg

Active Comparator Drug,Placebo Comparator Drug

Diazepam 10 mg,placebo

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The women who have indication for conization according to 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors.

Exclusion criteria

Exclusion criteria: History of diazepam allergy Pregnancy Cervical and vaginal infection Reception diazepam or benzodiazepine before procedure in 24 hours Cirrhosis GFR below 60 ml/min/1.73 m2) unstable blood pressure ( below 90/60 mmHg Or higher 160/110 mmHg ) insomnia, depression, central nervous system depression, or other mental diseases myasthenia gravis, attention deficit hyperactivity disorder,or chronic obstructive pulmonary disease cardiovascular events such as stroke, cerebral ischemia, or myocardial infarction before 6 month Blindness

Design outcomes

Primary

Measure	Time frame
Anxiety at before recieve the intervention and 1 hours after end of the intervention The State Trait Anxiety Inventory (STAI)	—

Secondary

Measure	Time frame
anxiety at before recieve the intervention and 1 hours after end of the intervention visual analogue scale,pain at 1 hours after end of the intervention visual analogue scale	—

Countries

Thailand

Contacts

Public ContactSattawat Charoenwong

Udonthani Hospital

bamboombankboat@gmail.com0824838436

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026