| CTRI Number |
CTRI/2026/02/103853 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Pre-surgery Educational Video on Anxiety and Vital Signs in Adults Undergoing Planned Orthopedic Surgery |
|
Scientific Title of Study
|
A randomized control trial to determine the effectiveness of a
Video based Pre-operative Special Surgical Instruction (V-POSSI) on
postoperative anxiety levels and vital signs among adult patients undergoing
planned orthopedic surgery at a tertiary care hospital |
| Trial Acronym |
V-POSSI Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somedutta Sarkar |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
AIIMS Kalyani |
| Address |
College of Nursing, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, District - Nadia, Kalyani, West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9433983059 |
| Fax |
|
| Email |
somedutta.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Somedutta Sarkar |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
AIIMS Kalyani |
| Address |
College of Nursing, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, District - Nadia, Kalyani, West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9433983059 |
| Fax |
|
| Email |
somedutta.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Somedutta Sarkar |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
AIIMS Kalyani |
| Address |
College of Nursing, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, District - Nadia, Kalyani, West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9433983059 |
| Fax |
|
| Email |
somedutta.nursing@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Somedutta Sarkar |
| Address |
College of Nursing, AIIMS Kalyani, West Bengal |
| 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 |
| Somedutta Sarkar |
AIIMS Kalyani |
College of Nursing, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, District - Nadia, Kalyani, West Bengal
Nadia
WEST BENGAL |
9433983059
somedutta.nursing@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine pre-operative care |
Participants allocated to the control group will receive routine preoperative care as per institutional protocol, which includes standard verbal instructions and counseling provided by healthcare professionals, without any additional video-based educational intervention. |
| Intervention |
Video-based Pre-operative Special Surgical Instruction (V-POSSI) |
Participants allocated to the experimental group will receive a 10-minute structured video-based pre-operative educational intervention in addition to routine preoperative care. The video provides standardized audiovisual information regarding preoperative preparation, operating theatre environment, anesthesia process, perioperative procedures, and expected postoperative experiences. The intervention will be administered approximately 24 hours prior to the scheduled orthopedic surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above
Patients scheduled for elective orthopedic surgery
Willingness to participate and provide informed consent
Adequate vision and hearing to view the educational video |
|
| ExclusionCriteria |
| Details |
Patients on chronic anxiolytics, sedatives, or antipsychotic medications
Patients with cognitive impairment or diagnosed psychiatric illness
Emergency surgery cases
Patients unwilling to provide informed consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative anxiety level measured using the Post operative anxiety rating scale and postoperative vital signs (pulse rate, blood pressure, respiratory rate) |
within 24–48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of postoperative anxiety levels and vital signs with selected socio-demographic variables |
within 24–48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="58"
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)
|
01/03/2026 |
| 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="1"
Months="0"
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
|
Brief Summary
Preoperative anxiety is a common problem among patients undergoing elective surgery and is associated with adverse physiological responses and unfavorable postoperative outcomes. Anxiety may lead to unstable vital signs, increased postoperative pain, delayed recovery, and prolonged hospital stay. Structured preoperative education has been shown to reduce anxiety and improve patient preparedness; however, evidence from Indian tertiary care settings, particularly in orthopedic surgery, remains limited.
This randomized controlled trial aims to evaluate the effectiveness of a Video-based Pre-operative Special Surgical Instruction (V-POSSI) in reducing postoperative anxiety levels and stabilizing vital signs among adult patients undergoing planned orthopedic surgery at a tertiary care hospital in West Bengal.
Eligible adult patients scheduled for elective orthopedic surgery will be recruited using purposive sampling and randomly allocated into experimental and control groups using block randomization with allocation concealment. The experimental group will receive V-POSSI in addition to routine care, while the control group will receive routine preoperative care alone.
The V-POSSI consists of a 10-minute structured educational video providing audiovisual information about the perioperative environment, anesthesia, operating theatre procedures, and expected postoperative experiences. The video will be administered approximately 24 hours prior to surgery.
Postoperative anxiety will be assessed using the Post Operative Anxiety Rating Scale, and postoperative vital signs (pulse rate, blood pressure, and respiratory rate) will be recorded from hospital vital signs charts. Data will be analyzed using descriptive and inferential statistics to determine the effectiveness of the intervention and associations with selected socio-demographic variables.
The findings of this study are expected to provide evidence on the feasibility and effectiveness of video-based preoperative education as a non-pharmacological intervention to reduce anxiety and improve physiological stability among orthopedic surgery patients in Indian tertiary care settings. |