CTRI

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CTRI Number

CTRI/2025/03/081716 [Registered on: 05/03/2025] Trial Registered Prospectively

Last Modified On:

19/02/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

How people feel about the impact of climate change on their health

Scientific Title of Study

Explore the Perception of People on the Effect of Climate Change on the Health Risk

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Sethulakshmi A S
Designation	Student
Affiliation	prasanna school of public health
Address	Department of Healthcare and Hospital Management no division Room LH3 Tiger circle road, Madhav Nagar, Manipal, Karnataka, India Udupi KARNATAKA 576104 India
Phone	7593986473
Fax
Email	sethulakshmi.psphmpl2023@leaner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Swathi K S
Designation	Associate Professor
Affiliation	Prasanna School of Public Health, Manipal Academy of Higher Education
Address	Department of School and Health innovation Prasanna School of Public Health, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	9481749911
Fax
Email	swathi.ks@manipal.edu

Details of Contact Person
Public Query

Name	Dr Swathi K S
Designation	Associate Professor
Affiliation	Prasanna School of Public Health, Manipal Academy of Higher Education
Address	Department of School and Health innovation Prasanna School of Public Health, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	9481749911
Fax
Email	swathi.ks@manipal.edu

Source of Monetary or Material Support

Explore the Perception of People on the Effect of Climate Change on Health Risk is conducted with the infrastructural support provided by: Prasanna school of public health, Manipal academy of higher education Tiger Circle Road , Madhav Nagar Manipal Udupi Karnataka India pin: 576104

Primary Sponsor

Name	Sethulakshmi A.S
Address	Department of Healthcare and Hospital Management,No division Room no LH3 Tiger Circle Road,Madav Nagar, Manipal,Karnataka,India 576104
Type of Sponsor	Other [Self]

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 Swathi KS	prasanna school of public health	Department of Healthcare and Hospital Management no division Room no 68 Tiger Cicle Road, Madhav Nagar,Manipal,Karnataka,India pin:576104 Udupi KARNATAKA Udupi KARNATAKA	9481749911 swathi.ks@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba medical college and kasturba hospital instituional ethics committe -2	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	effects of climate change on health risk

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Individuals aged 18 years and above. 2. Individuals who are willing to participate

ExclusionCriteria

Details

1.Individuals below 18 years
2. Individuals who cannot understand English.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
25 questions related to effects of climate change on health risk will be given to each participant and the outcome will be determined using the data gathered from the questionnaire	4 weeks

Secondary Outcome

Outcome	TimePoints
There are no specific intervention or endpoint criteria as this is an observational study focused on assessing effects of climate change on health risk	4 weeks

Target Sample Size

Total Sample Size="422"
Sample Size from India="422"
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)

14/03/2025

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 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

To assess and analyse the perception of people on the effect of climate change on health risks.

Objectives: 1. To identify the general awareness of climate change and its potential health risks.

2. To evaluate the perceived severity and susceptibility to health risks associated with climate change.

Justification for study: Clmate change poses significant health risks, including respiratory illaesses, heat-related conditions, and the spread of diseases (Watts et al., 2019). However, public perception of these risks remains poorly understood. Assessing people’s awareness and perceptions is essential for improving public health preparedness (Leiserowitz et al., 2021), informing policy development, and enhancing climate adaptation efforts (Ebi & Hess, 2020). Understanding how individuals pereeive the severity and susceptibility to health risks will also help improve communication strategies and promote protective behaviors (van Valkengoed & Steg, 2019). This study aims to fill eritical knowledge gaps and support more effective public health interventions.

Departments involved: Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE.

Study period: October 2024 to February (5 Months)

Sample size: Confidence level (Z) = 1.96 for 95% confidence level Margin of error (d) = 0.05 (or 59%) Anticipated proportion of individuals with the outcome of interest (p) = assumed to be 0.5 (50%) n-Zxpx (1-p) / d² n=(1.96) ²x0.5x (1-0.5)) (0.05) 2 n=3.8416x 0.25/0.0025 n-0.9604/0.0025 n384.16 n=384.16 + 10% of non-responders and partial responders n=384+38-422 Therefore, the total sample size would be 422 participants.

8. Materials and methods: a) Inclusion criteria D Individuals aged 18 years and above.

Exclusion criteria a) Individuals below 18 years

b)Individuals who cannot understand English.

Biological materials required (type - blood, tissue etc and quantity): Nil

Statistical methods: Descriptive and Inferential statistical analysis will be done.

Tools used: A pre- validated questionnaire to assess the effect of climate change on the healthcare system.

Detailed description of procedure / processes : Permission and Clearance: IRC approval from PSPH, MAHE and IEC approval from KMC & KH, Manipal.

* The study population consists of individuals aged 18 years and albove, who can understand English.

* The study uses non-random, convenience sampling. Participants are selected using the contacts in personal and professional network, based on their availability and willingness to take part. Secondary contacts are obtained from the participants till the researcher gathers the estimated sample.

* Informed consent from the individuals participating in the study will be obtained by providing them with all necessary information, including the study’s purpose and procedures.

* An online structured questionnaire will be administered to the individuals who agree to participate in the study to assess their perception on the effect of health risk during climate change by sending direct messages and e-mails or posting a request in relevant groups.

*The data obtained will then be analyzed.

Outcome measures: Awareness level of climate change and related health risks.