Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
Primary Purpose
Anxiety, Surgery, Spinal Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimedia video information
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video Group
non video group
Arm Description
Video 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.
patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.
Outcomes
Primary Outcome Measures
Change in anxiety
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.
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04387487
First Posted
April 30, 2020
Last Updated
January 7, 2021
Sponsor
Chitwan Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04387487
Brief Title
Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
Official Title
Effect of Multimedia Video Information in Relieving Anxiety Related to Spinalanesthesia. A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chitwan Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.
Detailed Description
Anxiety is common in perioperative patients with incidence of 60-89 %. Lack of knowledge about surgery and anesthesia, anesthesia procedures and unfamiliar surroundings are the common causes of anxiety . Anxiety related to anesthesia can be due to lack of knowledge about its process, procedures and risk associated with it or misconceptions about it. Long NPO status and unexpected delay before and during anesthesia procedure and surgery further increases the anxiety in perioperative patients. Anxiety increases the activity of sympathetic nervous system and cause preoperative and intraoperative tachycardia, hypertension, arrhythmias, increased pain perception and increase requirement of anaesthetic drugs. This may lead to harmful effect on patient health and decrease overall patient satisfaction and even traumatic experience for rest of life. This may affect process of giving informed consent for the planned surgery. Many measures are taken to allay anxiety in perioperative patients. Anxiolytic medications are given preoperative period to allay anxiety but they may have detrimental effect on patient health, requires administration under supervision of health professional and may not be effective unless the cause of anxiety is taken care. Counselling regarding the procedure of anesthesia during pre-anesthetic check up is other way to allay anxiety but transfer of knowledge is usually limited and may not be entirely retained. Other method in the form of written pamphlets, booklet or questionnaires have been tried but most of the patients in Nepal are not literate enough to read and understand it. Multimedia information to allay patient's anxiety has been successfully tried. Previous study shows a significant reduction in anxiety level due to preoperative multimedia information among the patients undergoing surgery. Investigators have developed a short visual clip of 4.5 minutes duration depicting the procedure of spinal anaesthesia .Investigators will be using Hamilton Anxiety Score in patients undergoing surgical procedures under spinal anesthesia .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Surgery, Spinal Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention name- multimedia video information Intervention details- 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.
Masking
ParticipantInvestigator
Masking Description
participant and investigators will be masked
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video Group
Arm Type
Experimental
Arm Description
Video 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.
Arm Title
non video group
Arm Type
No Intervention
Arm Description
patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.
Intervention Type
Behavioral
Intervention Name(s)
Multimedia video information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
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.
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)
Time Frame
1) During pre anesthesia check up before providing verbal or multimedia information. 2) one hour before the surgery 3) 8 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepak Bhandari, MD
Phone
+9779851123608
Email
drbhandari.crc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nabin Krishna Yadav, MD
Phone
+9779842163493
Email
korgiya@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
patients Hamilton scores and data regarding the study will be provided.
IPD Sharing Time Frame
data will be available after the study is completed to only people who request to view the data
IPD Sharing Access Criteria
data will be shared only for academic purpose
Citations:
PubMed Identifier
8315804
Citation
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.
Results Reference
background
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Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
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