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CTRI Number  CTRI/2024/09/073641 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding the relationship between physical activity and perceived stress among pregnant women  
Scientific Title of Study   Relationship between physical activity and perceived stress among pregnant women visiting tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Adrija Roy 
Designation  PG Student 
Affiliation  Manipal College of Health Professionals  
Address  Department of Clinical Psychology Manipal College of Health Professionals MAHE

Udupi
KARNATAKA
576104
India 
Phone  9513404066  
Fax    
Email  adrijaroy048@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Indu Toby 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professionals  
Address  Department of Clinical Psychology Manipal College of Health Professionals MAHE

Udupi
KARNATAKA
576104
India 
Phone  9482784595  
Fax    
Email  indu.toby@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sweta Kulkarni 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professionals  
Address  Department of Clinical Psychology Manipal College of Health Professionals MAHE

Udupi
KARNATAKA
576104
India 
Phone  99000380831  
Fax    
Email  sweta.kulkarni@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology Manipal College of Health Professional MAHE 576104 Karnataka, India  
 
Primary Sponsor  
Name  Ms Adrija Roy 
Address  Department of Clinical Psychology 5th Floor Manipal College of Health Professional MAHE 576104 Karnataka, India  
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 
Ms Adrija Roy  Kasturba Medical Hospital, Manipal- 576104  Ground floor at Department of OBG
Udupi
KARNATAKA 		 9513404066

adrijaroy048@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Kasturba Medical College and Kasturba Hospital (KMC and KH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  • Pregnant women aged between 18 to 40 years
• Period of gestation: 14-36 weeks and
Participants who can read and understand English at a basic level
 
 
ExclusionCriteria 
Details  People diagnosed with psychiatric conditions
• People with neurological or musculoskeletal complications which prevents them from
being physically active.
• Assistive pregnancy
• Women with high risk pregnancy who are advised bed rest by clinicians
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
One of the major outcome of this study is development of
interventions and strategies that would help to tackle levels of stress during pregnancy. This study can
help to understand the specific patterns of physical activity that would be beneficial in dealing with
stress more efficiently, which eventually can help one take better care of their mental health during
their pregnancy. 		 7 months 
 
Secondary Outcome  
Outcome  TimePoints 
Strategies that can better help deal with mental health conditions ( stress) during pregnancy  7 Months 
Another secondary outcome includes to compare the amount of stress across different types
of physical activities (3 types of physical activities considered) and understand the type of physical
activity that produces higher/lower levels of stress during pregnancy.  		 7 months 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   16/09/2024 
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="7"
Days="28" 
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   This particular study is conducted on the topic titled " Relationship between physical activity and perceived stress among pregnant women visiting tertiary care hospital". The aim of the study is to study the relationship between physical activity and perceived stress among pregnant women visiting tertiary care hospital. The primary objective of the study is to study patterns of physical activity & perceived stress amongst pregnant women. The main rationale behind this study is to understand that how physical activity can have a impact on the perceived stress levels of pregnant women. With understanding to efficiently deal with stress during pregnancy with the help of physical activities during pregnancy, can help them to better tackle with the mental health concerns during this time. Physical activities or exercises in turn can also physiologically aid in the process of labor and following which and can also help with the postpartum recovery. This study can be beneficial or contributory in formulating some strategies in boosting maternal health care. 

The present study will involve a quantitative approach with a cross-sectional design, which will include 85 participants who are pregnant women visiting Department of OBG, Kasturba Hospital. The study tools will include Perceived Stress Scale (PSS) and Global Physical Activity Questionnaire (GPAQ). Before administering the questionnaires, a copy of Participant Information Sheet and Informed Consent will be given to participants with proforma, after which the aforementioned questionnaires will be administered. Participants will be given questionnaires and response sheets. Responses collected will be analysed and related to the review of our literature to draw inferences for the study.

Scores of PSS and GPAQ will be attained at the end of the study and assessed. Statistical analysis of Correlational Analysis will be conducted Pearson’s/Spearman’s correlation will be performed to find the relationship between between types of physical activity and levels of perceived stress.
 
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