CTRI

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CTRI Number

CTRI/2025/04/083942 [Registered on: 02/04/2025] Trial Registered Prospectively

Last Modified On:

27/03/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

Study on anxiety levels before and after explaining spinal anesthesia to patients.

Scientific Title of Study

A prospective observational study to compare pre and post anxiety score following demonstration of spinal anesthesia in patients undergoing elective surgery

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	S Thivya
Designation	Postgraduate MSc Anesthesia Technology
Affiliation	SRM medical college and hospital
Address	Room no 22 Department of Anesthesiology SRM medical college and hospital SRM Nagar Kattankulathur Kancheepuram TAMIL NADU 603203 India
Phone	6380814051
Fax
Email	ts0887@srmist.edu.in

Details of Contact Person
Scientific Query

Name	Dr G Mirunalini
Designation	Associate professor
Affiliation	SRM Institute of Science and Technology
Address	No 209 B block Second floor Department of Anesthesiology SRM Medical college hospital and research centre SRM nagar Kattankulathur Kancheepuram TAMIL NADU 603203 India
Phone	9486131643
Fax
Email	mirunalg@srmist.edu.in

Details of Contact Person
Public Query

Name	Dr G Mirunalini
Designation	Associate professor
Affiliation	SRM Institute of Science and Technology
Address	No 209 B block Second floor Department of Anesthesiology SRM Medical college hospital and research centre SRM nagar Kattankulathur Kancheepuram TAMIL NADU 603203 India
Phone	9486131643
Fax
Email	mirunalg@srmist.edu.in

Source of Monetary or Material Support

SRM Medical college hospital and research centre SRM Nagar kattankulathur Chengalpattu district Tamil Nadu India 603203

Primary Sponsor

Name	SRM Medical college and hospital
Address	SRM Medical college and hospital SRM Nagar Potheri 603203
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Mirunalini G	SRM Institute of Science and Technology	Room No 22 Second floor B block Department of Anaesthesiology SRM Medical college hospital and research centre SRM Nagar Kattankulathur 603203 Kancheepuram TAMIL NADU	9486131643 mirunalg@srmist.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Patient scheduled for elective surgery under spinal anesthesia

ExclusionCriteria

Details

Patient refusal
Unconscious, unco-operative, a psychiatric disorder, illiterate

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare Pre and post anxiety score after video based explanation on spinal anaesthesia in patients posted for elective surgery	During the first visit of patient to pre anaesthetic assessment clinic After the patient comes out from pre anaesthetic assessment clinic On the morning of surgery in pre medication room

Secondary Outcome

Outcome	TimePoints
To identify correlation between different demonstration methods and anxiety level	After the end of surgery

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

15/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

JUSTIFICATION:

By providing information to the patients in the pre assessment clinic by explaining to them about the spinal anaesthesia procedure, we aim to improve the post operative outcome of the patient by reducing the anxiety levels.

HYPOTHESIS:

Pre operative explanation about the spinal anesthesia procedure has a positive effect on anxiety level of the patient and reduces anxiety

METHODOLOGY:

• A thorough pre-anaesthetic check-up will be done by anesthesiologist on patients after arrival to pre-op assessment room.

• Patient anxiety score will be taken initially by the principal investigator before the patient goes inside the PAC.

• Explanation about spinal anesthesia will be given by the anesthesiologist to the patient.

• Again post explanation anxiety score will be taken 2 times by the principal investigator:

(i) during exit from the assessment clinic

(ii) again second time on the morning of surgery.

• Pre and post anxiety score will be measured by Amsterdam preoperative anxiety and information scale (APAIS)

• Methods used for demonstration of spinal anaesthesia by the attending anaesthesiologist will be either of the following depending on their protocol

i) Oral explanation methods

ii) Video based explanation methods