| CTRI Number |
CTRI/2025/01/079518 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of training on endoscopy experience before hand to reduce anxiety |
|
Scientific Title of Study
|
Effectiveness of Nurse-led intervention on anxiety and stress among patients undergoing upper gastrointestinal endoscopy in a Tertiary care Hospital, Mangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jinumol Mathew |
| Designation |
MSc Nursing student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Medical Surgical Nursing, 1st MSc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8848094477 |
| Fax |
|
| Email |
jossymaria66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Jubee Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Department of Medical Surgical Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8722831688 |
| Fax |
|
| Email |
jubeejoseph@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Denitha T |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Department of Medical Surgical Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7975123394 |
| Fax |
|
| Email |
denithatj@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital,
Manguluru, Karnataka
Jinumol Mathew (Self Funded)Father Muller college of Nursing Mangaluru,Kankanady,Karnataka
575002 |
|
|
Primary Sponsor
|
| Name |
Jinumol Mathew |
| Address |
Father Muller College of Nursing, Medical Surgical Nursing,1st MSc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Mrs Jubee Joseph |
Endoscopy Room, 2nd floor,Father Muller Medical College Hospital ,Room-202 |
Endoscopy Room
2nd floor
Father Muller Charitable Institution, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002
Dakshina Kannada
KARNATAKA |
8722831688
jubeejoseph@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no theraphy is provided |
no theraphy is provided for samples but pretest and post test will be conducted to evaluate the comparison of effect of procedure and to identify factors influence the same |
| Intervention |
nurse led intervention |
In this study it includes a pre-procedural explanation relating to the sensations and sequence of events associated with the endoscopy procedure(10min), swallowing method [Instruct and demonstrate the patient to swallow saliva as a rehearsal of swallowing scope -3times](2min), tongue depressor task [By tongue depressor helps the patient to experience gag reflex-3times](3min) and deep breathing exercises. [Breath focus technique and Alternate nostril breathing](5min). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18-70 years of both genders
Planned cases of upper gastrointestinal endoscopy
Mentally alert and able to communicate freely.
|
|
| ExclusionCriteria |
| Details |
Patients who are:
1. Sedated/confused.
2. Having a diagnosis of significant behavior disturbance.
3. Already exposed previously to upper gastrointestinal endoscopy
4. Emergency cases of upper gastrointestinal endoscopy
5. Hearing or visual difficulty
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce anxiety and stress through nurse led intervention |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evidenced based practice for nurse led intervention |
5years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Endoscopy is an important diagnostic procedure for upper gastro intestinal disorders. Anxiety and stress are major concern during upper gastro intestinal endoscopy. Different medicinal and non-pharmacological approaches are available conforming and managing anxiety and stress during upper gastrointestinal endoscopy . Proper procedure preparation can affect in reduction of anxiety and to get further cooperation during the procedure. A study will be conducted to evaluate the effectiveness of Nurse-led intervention on anxiety and stress among patients undergoing upper gastrointestinal endoscopy in a Tertiary care Hospital, Mangalore The study will be conducted at the Father Muller Medical college hospital in endoscopy unit. Sample size consists of 60 ,upper gastro intestinal endoscopy patients who met the inclusion criteria by using the purposive sampling technique. Anxiety and stress will be assessed by State-Trait Anxiety Inventory Scale (STAI Y1) & Visual Analog scale for stress. The study will be started with pre-assessment and administration of Nurse led- Intervention only for experimental group for 15 minutes to 20 minutes duration before the endoscopy procedure. Post test will be done after 20 minutes of intervention for both the groups. There are plenty articles which proves the effect of nurse-led intervention on anxiety and stress among patients undergoing upper gastrointestinal endoscopy. Therefore, the researcher felt the need to conduct research by performing pre-procedural preparation along with breathing ways to reduce stress and anxiety among patients undergoing endoscopy. |