Comparing the effectiveness of anti-anxiety drug midazolam alone, with stress ball or with hand-holding and conversation in reducing anxiety before surgery in keyhole type of gallbladder removal surgery

To compare the efficacy of Midazolam alone, with Stress ball or with Hand-holding and Conversation in reducing preoperative anxiety in elective laparoscopic cholecystectomy - A randomized controlled study - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060560

Enrollment

150

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K802- Calculus of gallbladder without cholecystitis Health Condition 3: K808- Other cholelithiasis Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Inj Midazolam (0.05mg/kg IV) along with Hand-holding and Conversation for 15 minutes.: inj midazolam will be given and hand-holding and conversation will be done for 15 minutes with

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 30-50 years. 2. American Society of Anesthesiologists (ASA) physical class I and II. 3. Either sex (Male/Female). 5. Rural population. 4. Patient scheduled to undergo elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: 1.Patients refusal. 2.Known history of anxiety disorders. 3.Neuro psychiatric disorders or on chronic use of psychoactive medications. 4.Visual and hearing impairment. 5.Amputated upper limbs. 6.Patients taking beta blockers. 7.Patients having history of drug/substance abuse. 8.Duration of surgery more than 3 hours.

Design outcomes

Primary

Measure	Time frame
Amsterdam Preoperative Anxiety and Information Scale (APAIS).Timepoint: before and after 15 minutes of intervention	—

Secondary

Measure	Time frame
MAC values requirement based on BIS, compare haemodynamic parameters (heart rate and mean blood pressure), compare post operative pain using visual analogue score, compare patient satosfaction scoreTimepoint: 12 hours	—

Countries

India

Contacts

Public ContactMitul Mukherjee

Uttar Pradesh University of Medical Sciences, Saifai, Etawah

ushashukla1970@gmail.com9529777771

Outcome results

None listed

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