Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
Effect of Multimedia Video Information in Relieving Anxiety Related to Spinalanesthesia. A Randomized Control Trial
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Mar 2021
Shorter than P25 for not_applicable anxiety
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2021
CompletedJanuary 8, 2021
January 1, 2021
4 months
April 30, 2020
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in anxiety
1. During pre anesthesia visit before conduction pre anesthesia checkup a base line level anxiety will be measured among both the group of patients. After this pre anesthesia examination will be conducted. The intervention group will be then asked to watch multimedia video information where as other group will be provided with verbal information only. 2. Change in anxiety level will be measured at one hour before the surgery and eight hours after the surgery among the both the group using same scoring system. Change in anxiety level will be assessed using the Hamilton anxiety rating scale which ranges from minimum 0 and maximum 56 (higher score means poor outcome high level of anxiety)
1) During pre anesthesia check up before providing verbal or multimedia information. 2) one hour before the surgery 3) 8 hours after the surgery
Study Arms (2)
Video Group
EXPERIMENTALVideo Group multimedia video information of 4.5 mins regarding procedure, indication and complications related to spinal anesthesia will be shown to patients in intervention group , patient will be allowed to ask questions.
non video group
NO INTERVENTIONpatients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.
Interventions
During pre anesthesia visit after regular pre anesthesia check up patient will be asked to fill the Hamilton scoring questionnaire about anxiety. After this a multimedia video information about spinal anesthesia of around 6 minutes will be shown to the intervention group during pre anesthesia visit. This video will contain explanation about how spinal anesthesia procedure is conducted. Patient will be allowed to ask questions. On the day of surgery in the pre surgical area again Hamilton scoring questionnaire will be asked with the patients to check the level of anxiety.
Eligibility Criteria
You may qualify if:
- \- All patients between 18 and 65 years of age of either sex undergoing elective surgery under SAB were included.Only patients in ASA category 1 and 2 will be included.
You may not qualify if:
- Patients refusing to give consent for the study,
- Patients Having significant cardiovascular or neurological disease,
- Patients On medications such as beta blockers, antidepressants, cardiac or psychiatric drugs,
- Pregnant patients and
- Patients those who had undergone procedures under SAB in the past
- Patients facing any major complications after the surgery such as massive blood loss, having to convert to general anesthesia due to lengthy surgical procedure, patients requiring critical care administration after the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hashimoto Y, Baba S, Koh H, Takagi H, Ishihara H, Matsuki A. [Anxiolytic effect of preoperative showing of "anesthesia video" for surgical patients]. Masui. 1993 Apr;42(4):611-6. Japanese.
PMID: 8315804BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- participant and investigators will be masked
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anesthesiologist
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 13, 2020
Study Start
March 1, 2021
Primary Completion
June 30, 2021
Study Completion
July 5, 2021
Last Updated
January 8, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- data will be available after the study is completed to only people who request to view the data
- Access Criteria
- data will be shared only for academic purpose
patients Hamilton scores and data regarding the study will be provided.