| CTRI Number |
CTRI/2023/10/059099 [Registered on: 25/10/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of viewing video information on anxiety prior to surgery under spinal anaesthesia in female patients. |
|
Scientific Title of Study
|
To evaluate the effect of video education on preoperative anxiety in female patients ungergoing surgery under spinal anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayuri Golhar |
| Designation |
Associate Professor |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Room no 29, Second Floor, New OT Complex, Pt BDS PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9599912334 |
| Fax |
|
| Email |
drmayuriyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri Golhar |
| Designation |
Associate Professor |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Room no 29, Second Floor, New OT Complex, Pt BDS PGIMS,
Rohtak
HARYANA
124001
India |
| Phone |
9599912334 |
| Fax |
|
| Email |
drmayuriyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkata Krishna Teja M |
| Designation |
Junior Resident |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Second Floor, New OT cum ICU Complex, Deptt of Anaesthesia and Critical Care, Pt BDS PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9100621657 |
| Fax |
|
| Email |
krishnatejanaidu29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Pt BD Sharma PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Mayuri Golhar |
Pt BDS PGIMS, Rohtak |
Room no 29, Second
Floor, Deptt of
Anaesthesiology, New
OT cum ICU Complex
Rohtak
Rohtak
HARYANA |
9599912334
drmayuriyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt BD Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Control group C: will receive verbal briefing about spinal anaesthesia for 10 mins. |
| Intervention |
Video education |
Video group V: who will watch an educational multimedia video about spinal anaesthesia of 10 minutes duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All female patients of age 18 years to 60yrs, belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled to undergoing elective surgery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Contraindications to spinal anaesthesia, Mental disorders and patients on treatment for any psychiatric illness, Patients with major cardiac, renal and hepatic impairment, Previously received spinal anaesthesia, Pregnancy, Hearing and visual impairment, Patients with poor GCS, Patient refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the effect of viewing video information on preoperative anxiety using APAIS score in female patients undergoing surgery under spinal anaesthesia. |
A(0) - Base line evening before surgery.
A(1) - Post intervention.
A(2) - 30 mins before surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect of anxiety on hemodynamic parameters.
Heart Rate (HR),Systolic Blood Pressure (SBP),Diastolic Blood Pressure (DBP) |
H(0)- Base line evening before surgery
H(1)- Post intervention
H(2)- 30 mins prior to surgery
H(3)- immediately before spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Title : To evaluate the effect of viewing video information in reducing preoperative anxiety in female patients undergoing surgery under spinal anaesthesia.
Aim : To evaluate the effect of viewing video information in reducing preoperative anxiety in female patient undergoing surgery under spinal anaesthesia.
Primary Objective : 1. To asses the effect of viewing video information on preoperative anxiety using APAIS score in female patients undergoing surgery under spinal anaesthesia.
Secondary Objective : 1 To observe the effect of anxiety on hemodynamic parameters. 2 To identify associated causes for the development of anxiety.
Inclusion criteria : All female patients of age 18 years to 60yrs, belonging to American Society of Anesthesiologists (ASA) physical status I - II scheduled to undergoing elective surgery under spinal anaesthesia.
Exclusion criteria : Patient refusal, contraindications to spinal anaesthesia, mental disorders, patients on antidepressants, beta blockers, previously received spinal anaesthesia, hearing and visual impairment.
Sample Size : 110
Group allocation : Video group (n = 55) = video viewed Control group (n=55) =verbal information given
Assessment : Effect on APAIS anxiety score. Effect of anxiety on hemodynamic parameters Causes for developing anxiety
Analysis: Data will be compiled, compared and appropriate statistical test will be applied to analyse the results
|