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Evaluation of anxiety in patients undergoing surgery

Completed
Conditions
Adult ASA 1 and 2Age between 18 -65 yearsUndergoing various elective surgeries
Registration Number
CTRI/2016/08/007214
Lead Sponsor
Self
Brief Summary

Anxiety is common in surgical patients during the preoperative period. High levels of preoperative anxiety may have unfavorable effects on induction and maintenance of anaesthesia as well as on the recovery from anaesthesia and surgery. Anxious patients may require higher doses of anaesthetic induction agents and postoperative analgesic drug.

Primary Objective: To evaluate reduction in anxiety levels on theday before surgery as regards to the information known by the patient regardingthe diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providingthem the information for the same

Secondary Objective: To determine the factors responsible forpreoperative anxiety in surgical patients in Hospital

After noting basic demography, SECTION1 of questionaire consists of three questions to know the information patients have about thediagnosis, upcoming surgery procedure, type of anesthesia to be provided while SECTION 2 has a list of 16 questions relating toanxiety. The participants will select different factors responsible for theiranxiety from this list. The level of patients’ anxiety assessed with the visualanalogue scale (VAS). Eachparticipant will in addition be requested to make an assessment of averagepersonal level of anxiety to be assessed by VAS score.

The patient will be randomly allotted one ofthe two groups. The study group and control group. The study group will receivethe information about the diagnosis, the surgery to be performed, and the typeof anaesthesia. The control group will not be given any information.

The average personal level of anxiety of thepatient will again be assessed with VAS score in both the groups. To find out the incidence of preoperativeanxiety by VAS of the 16 factors. A score of at least 45mm on the VAS will be regarded as significant anxietyfor each factor Maximum value -1500 Minimum value- 0 Significant anxiety-675

To determine the influence of gender, age,educational level and previous surgical treatment on anxiety using appropriatestatistical tests.

The study will be conducted in 84 subjects and appropriate statistical analysis will be done.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
84
Inclusion Criteria

Adult ASA 1 and 2 Age between 18 -65 years Undergoing various elective surgeries.

Exclusion Criteria

Pregnancy Transplant surgery Neurological diseases Aged under 18 or older than 65 Known psychiatric illness Patients on anxiolytic medication Those unable to read.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate reduction in anxiety levels on the day before surgery as regards to the information known by the patient regarding the diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providing them the information for the sameBefore pre-anaesthetic assessment on the day prior to surgery before visiting hours
Secondary Outcome Measures
NameTimeMethod
To determine the factors responsible for preoperativeanxiety in surgical patients in Hospital

Trial Locations

Locations (1)

GSMC & KEMH

🇮🇳

Mumbai, MAHARASHTRA, India

GSMC & KEMH
🇮🇳Mumbai, MAHARASHTRA, India
Dr Prerana Nirav Shah
Principal investigator
9869117027
PPS@KEM.EDU

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