CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/04/084269 [Registered on: 07/04/2025] Trial Registered Prospectively

Last Modified On:

07/04/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Single Arm Study

Public Title of Study

Study on how Anxiety before surgery affects Pain Medicine use after surgery in patients who are undergoing surgery for child birth.

Scientific Title of Study

A prospective observation study of correlation between preoperative anxiety and postoperative analgesia consumption in patients undergoing caesarean section under spinal anaesthesia

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dhilleswari G
Designation	Post graduate Msc Anaesthesia Technology
Affiliation	SRM medical college and hospital SRM Nagar Potheri
Address	Room no 22 Department of Anesthesiology SRM Medical college and hospital Chennai TAMIL NADU 603203 India Kancheepuram TAMIL NADU 603203 Kancheepuram TAMIL NADU 603203 India
Phone	7032087406
Fax
Email	Dhilleswari.g14@gmail.com

Details of Contact Person
Scientific Query

Name	Dr G Mirunalini
Designation	Associate professor
Affiliation	SRM medical college and hospital SRM Nagar Potheri
Address	Room no 22 Department of Anesthesiology SRM Medical college and hospital Chennai TAMIL NADU 603203 India Kancheepuram TAMIL NADU 603203 Kancheepuram TAMIL NADU 603202 India
Phone	9486131643
Fax
Email	mirunalg@srmist.edu.in

Details of Contact Person
Public Query

Name	Dr G Mirunalini
Designation	Associate professor
Affiliation	SRM medical college and hospital SRM Nagar Potheri
Address	Room no 22 Department of Anesthesiology SRM Medical college and hospital Chennai TAMIL NADU 603203 India Kancheepuram TAMIL NADU 603203 Kancheepuram TAMIL NADU 603202 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	Private medical college

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 Kancheepuram TAMIL NADU	9486131643 mirunalg@srmist.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee of SRM Medical College Hospital And Research centre	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
Comparator Agent	NIL	NILL
Intervention	NILL	NILL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	1.Patient scheduled for both elective surgery and emergency surgeries under spinal anaesthesia

ExclusionCriteria

Details

1.Patient refusal
2.Unconscious, uncooperative, a psychiatric disorder, illiterate, allergy to drugs.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To Correlation between pre operative anxiety and post operative analgesia consumption	assessing will include Preoperative anxiety will be assessed 12–24 hours before surgery, and postoperative analgesia consumption will be recorded at 2, 4, 6 and 12 hours after surgery.

Secondary Outcome

Outcome	TimePoints
To identify risk factors associated with pre operative anxiety	assessing will include preoperative risk factors and Preoperative anxiety will be assessed 12–24 hours before surgery, .

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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)

05/05/2025

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="1"

Recruitment Status of Trial (Global)

Not Applicable

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

Aim of the study

This study evaluates the correlation between preoperative anxiety and postoperative analgesia consumption in patients undergoing Caesarean section under spinal anesthesia.

Methodology

A prospective observational study will be conducted at SRM Medical College and Hospital, involving 100 patients aged above 18 years. Preoperative anxiety will be assessed 12–24 hours before surgery using the State-Trait Anxiety Inventory (STAI) , while postoperative analgesic consumption will be recorded at 2, 4, 6 and 12 hours. This study aims to determine whether higher anxiety levels lead to increased postoperative analgesic requirements, helping improve pain management strategies for better patient outcomes.

Justification of the study

Findings from this study may assist in developing targeted preoperative interventions to reduce anxiety and optimize postoperative recovery. Understanding this correlation can lead to more effective multimodal pain management protocols in clinical practice.