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
Phase 2
- Conditions
- Health Condition 1: K801- Calculus of gallbladder with othercholecystitisHealth Condition 2: K802- Calculus of gallbladder without cholecystitisHealth Condition 3: O- Medical and SurgicalHealth Condition 4: K808- Other cholelithiasis
- Registration Number
- CTRI/2023/12/060560
- Lead Sponsor
- ttar Pradesh University of Medical Sciences, Saifai, Etawah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amsterdam Preoperative Anxiety and Information Scale (APAIS).Timepoint: before and after 15 minutes of intervention
- Secondary Outcome Measures
Name Time Method 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