| CTRI Number |
CTRI/2025/09/094966 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effect of frequent blood tests on pain levels and mental health |
|
Scientific Title of Study
|
Impact of repeated arterial blood gas sampling on pain perception and mental health in conscious patient; A cross sectional observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC-4/2025/083 Version 02 21/08/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chithra |
| Designation |
Student |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
MSc in Respiratory Therapy (Student)
Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
9448828536 |
| Fax |
|
| Email |
chithrabgy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavya Shettigar K |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
Guide,
Department of Respiratory Therapy
Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
9741734428 |
| Fax |
|
| Email |
kavyashettigar@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Kotian |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
Co Guide,
Department of Respiratory Therapy
Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
7026751960 |
| Fax |
|
| Email |
anjalikotian@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ. |
|
|
Primary Sponsor
|
| Name |
Chithra |
| Address |
Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chithra |
Yenepoya Medical College Hospital |
MICU and Step-Down ICU
Yenepoya Medical College Hospital, University road, Deralakatte, Mangalore, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
9448828536
chithrabgy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe-4 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Conscious adults (18 - 65 years old) undergoing 2 or more than 2 ABG samplings within 24 hours for medical monitoring.
Participants of any gender will be included in the study.
Participants who are able to read and write independently are included.
Participants willing to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Participants with impaired cognition or communication barriers.
Participants requiring mechanical ventilation and participants with do not intubate orders.
Participants with pre-existing mental health disorders.
Participants with repeated ABG sampling performed on consecutive days (Assessment was conducted only once for each participant)
Participants unable to provide informed consent or complete the questionnaire.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Repeated ABG sampling has significant effect on pain perception and mental health in conscious patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="255"
Sample Size from India="255"
Final Enrollment numbers achieved (Total)= "255"
Final Enrollment numbers achieved (India)="255" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
16/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 study is a cross-sectional observational study conducted in the ICU and step-down ICU of Yenepoya Medical College Hospital, Mangalore, over a period of 1 year and 2 months (May 2025–July 2026). It aims to assess the impact of repeated arterial blood gas (ABG) sampling on pain perception and mental health in conscious adult patients. A total of 255 participants aged 18–65 years, undergoing two or more ABG samplings within 24 hours, will be selected using systematic random sampling. Demographic and clinical data will be collected from medical records, and participants will complete a pain intensity scale and a modified Oxford Needle Experience (ONE) scale questionnaire to assess pain, anxiety, fear, and psychological impact. Data will be analyzed using descriptive statistics and Spearman rank correlation to identify associations between frequency of ABG sampling and pain or mental health outcomes. The study is self-funded, ethically approved, involves no additional interventions beyond routine care, and aims to generate evidence to improve patient-centered pain management strategies. |